3-months - Northumbria University Research Portal
Exercise-induced attenuation of treatment side-effects in newly diagnosed prostate cancer patients beginning androgen deprivation therapy: a randomised controlled trialAbstractObjectives: 1) To assess whether exercise training attenuates the adverse effects of treatment in newly diagnosed prostate cancer patients beginning androgen deprivation therapy (ADT), and 2) to examine whether exercise-induced improvements are sustained after the withdrawal of supervised exercise. Patients and methods: Fifty prostate cancer patients scheduled for ADT were randomised to an exercise group (n = 24) or a control group (n = 26). The exercise group completed 3-months of supervised aerobic and resistance exercise training (2x/week for 60 min), followed by 3-months of self-directed exercise. Outcomes were assessed at baseline, 3-months, and 6-months. The primary outcome was difference in fat mass at 3-months. Secondary outcomes included fat-free mass, cardiopulmonary exercise testing variables, QRISK2 score, anthropometry, blood-borne biomarkers, fatigue, and quality of life (QoL). Results: At 3-months, exercise training prevented adverse changes in peak oxygen uptake (1.9 ml.kg-1.min-1, p = 0.038), ventilatory threshold (1.7 ml.kg-1.min-1, p = 0.013), oxygen uptake efficiency slope (0.21, p = 0.005) and fatigue (4.5, p = 0.024) compared with controls. After the supervised exercise was withdrawn, the differences in cardiopulmonary fitness and fatigue were not sustained, but the exercise group showed significantly higher QoL (8.5, p = 0.034) and a reduced QRISK2 score (-2.9%, p = 0.041) compared to controls. Conclusion: A short-term programme of supervised exercise for prostate cancer patients beginning ADT results in sustained improvements in QoL and cardiovascular event risk profile. Key words: Prostate cancer, androgen deprivation therapy, aerobic exercise, resistance training; urology.IntroductionAndrogen deprivation therapy (ADT) is often the first-line treatment for locally advanced and metastatic prostate cancer. Whilst the therapeutic benefits of ADT are well-established PEVuZE5vdGU+PENpdGU+PEF1dGhvcj5QYWdsaWFydWxvPC9BdXRob3I+PFllYXI+MjAxMjwvWWVh
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ADDIN EN.CITE.DATA [11], this evidence relates to the effects of exercise in patients that have already developed adverse effects from receiving long-term ADT. Given that these adverse health effects occur rapidly in the early stages of treatment PEVuZE5vdGU+PENpdGU+PEF1dGhvcj5BbGliaGFpPC9BdXRob3I+PFllYXI+MjAxMDwvWWVhcj48
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ADDIN EN.CITE.DATA [12, 13], it is pertinent to explore whether exercise administered concurrently with the initiation of ADT could retard or prevent treatment toxicities. To date, only one study has prescribed exercise at the commencement of ADT. Cormie et al. PEVuZE5vdGU+PENpdGU+PEF1dGhvcj5Db3JtaWU8L0F1dGhvcj48WWVhcj4yMDE1PC9ZZWFyPjxS
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ADDIN EN.CITE PEVuZE5vdGU+PENpdGU+PEF1dGhvcj5Db3JtaWU8L0F1dGhvcj48WWVhcj4yMDE1PC9ZZWFyPjxS
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ADDIN EN.CITE.DATA [11] reported beneficial effects of a 3-month supervised exercise intervention on body composition, strength, blood lipid profile, cardiopulmonary fitness and QoL in 63 prostate cancer patients beginning ADT at a single-centre PEVuZE5vdGU+PENpdGU+PEF1dGhvcj5Db3JtaWU8L0F1dGhvcj48WWVhcj4yMDE1PC9ZZWFyPjxS
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ADDIN EN.CITE.DATA [3, 14] and reductions in strength and physical function have been observed just 3-months after the cessation of supervised exercise in older adults ADDIN EN.CITE <EndNote><Cite><Author>Orange</Author><Year>2018</Year><RecNum>3193</RecNum><IDText>The Short-Term Training and Detraining Effects of Supervised Versus Unsupervised Resistance Exercise in Aging Adults</IDText><DisplayText>[15]</DisplayText><record><rec-number>3193</rec-number><foreign-keys><key app="EN" db-id="50wxdpzd9vd5r7e9t5b595djrfpttrxw9avp" timestamp="1536137046">3193</key></foreign-keys><ref-type name="Journal Article">17</ref-type><contributors><authors><author>Orange, S. T.</author><author>Marshall, P.</author><author>Madden, L. A.</author><author>Vince, R. V.</author></authors></contributors><titles><title>The Short-Term Training and Detraining Effects of Supervised Versus Unsupervised Resistance Exercise in Aging Adults</title><secondary-title><style face="italic" font="default" size="100%">Journal of strength and conditioning research</style></secondary-title></titles><periodical><full-title>Journal of strength and conditioning research</full-title></periodical><dates><year>2018</year></dates><urls></urls></record></Cite></EndNote>[15]. Therefore, the purpose of this study was to: (1) examine whether a supervised programme of aerobic and resistance exercise training reduces treatment-related side-effects in prostate cancer patients beginning ADT, and (2) to determine whether any exercise-induced improvements can be sustained by encouraging patients to maintain self-directed exercise after the withdrawal of supervision.Patients and MethodsNewly diagnosed prostate cancer patients listed for ADT by the urology multi-disciplinary team at the Norfolk and Norwich University Hospitals NHS Foundation Trust, UK, were recruited from urology outpatient clinics from 2012 to 2014. Inclusion criteria were histologically confirmed prostate cancer, aged 50-80 years, beginning luteinizing hormone-releasing hormone (LHRH) agonist treatment with or without radiotherapy, anticipated to remain on ADT for at least 6 months, be classified as 0 or 1 according to the World Health Organisation performance status, and not achieving 150 min·week-1 of moderate intensity physical activity during the last 6 months. Exclusion criteria were metastatic bone disease, previously treated with ADT, involvement in any other clinical trial, prior cardiovascular event or heart failure, chronic obstructive pulmonary disease (COPD) and an absolute contraindication to exercise testing or training ADDIN EN.CITE <EndNote><Cite><Author>ACSM</Author><Year>2010</Year><RecNum>2689</RecNum><IDText>ACSM's Guidelines for Exercise Testing and Prescription</IDText><DisplayText>[16]</DisplayText><record><rec-number>2689</rec-number><foreign-keys><key app="EN" db-id="50wxdpzd9vd5r7e9t5b595djrfpttrxw9avp" timestamp="1532620549">2689</key></foreign-keys><ref-type name="Book">6</ref-type><contributors><authors><author>ACSM</author></authors></contributors><titles><title>ACSM's Guidelines for Exercise Testing and Prescription</title></titles><edition>8th</edition><dates><year>2010</year></dates><pub-location>Philadelphia, PA</pub-location><publisher>Lippincott Williams & Wilkins</publisher><urls></urls></record></Cite></EndNote>[16]. Written informed consent was obtained before study participation and the protocol was approved by the East of England Regional Committee. This trial was registered at (trial ID: NCT03776045). Experimental designThis study was a single-centred, parallel groups, prospective, randomised controlled trial (RCT). After baseline testing, participants were randomly allocated 1:1 to a standard care control group or a standard care plus exercise group using a randomisation sequence created by an independent researcher (nQuery, Statistical Solutions, USA). Treatment allocation was concealed from the research team until after baseline measurements were collected. Outcome assessors and data analysts were blind to treatment allocation. Outcomes were assessed at baseline, 3-months (post-intervention), and 6-months (follow-up). Exercise interventionThe intervention was supervised by exercise science staff in the exercise science facilities at the University of East Anglia, UK, which is adjacent to the treating hospital. Participants competed two supervised exercise sessions per week for 12 weeks upon initiating ADT. Each session lasted ~60 min and included aerobic interval exercise on a cycle ergometer (Monark 824E; Varberg, Sweden) followed by resistance training. The aerobic exercise component involved a 5 min warm-up at light resistance (50 W) followed by 6 x 5 min bouts at an intensity of 11-15 on the 6-20 Borg Rating of Perceived Exertion (RPE) Scale ADDIN EN.CITE <EndNote><Cite><Author>Borg</Author><Year>1982</Year><RecNum>3308</RecNum><DisplayText>[17]</DisplayText><record><rec-number>3308</rec-number><foreign-keys><key app="EN" db-id="50wxdpzd9vd5r7e9t5b595djrfpttrxw9avp" timestamp="1544089507">3308</key></foreign-keys><ref-type name="Journal Article">17</ref-type><contributors><authors><author>Borg, G. A.</author></authors></contributors><titles><title>Psychophysical bases of perceived exertion</title><secondary-title>Med Sci Sports Exerc</secondary-title><alt-title>Medicine and science in sports and exercise</alt-title></titles><periodical><full-title>Med Sci Sports Exerc</full-title><abbr-1>Medicine and science in sports and exercise</abbr-1></periodical><alt-periodical><full-title>Med Sci Sports Exerc</full-title><abbr-1>Medicine and science in sports and exercise</abbr-1></alt-periodical><pages>377-81</pages><volume>14</volume><number>5</number><edition>1982/01/01</edition><keywords><keyword>Heart Rate</keyword><keyword>Humans</keyword><keyword>*Perception</keyword><keyword>*Physical Exertion</keyword><keyword>Psychophysiology/methods</keyword></keywords><dates><year>1982</year></dates><isbn>0195-9131 (Print)
0195-9131</isbn><accession-num>7154893</accession-num><urls></urls><remote-database-provider>NLM</remote-database-provider><language>eng</language></record></Cite></EndNote>[17], corresponding to approximately 55-85% age-predicted maximum heart rate (220 – age) ADDIN EN.CITE <EndNote><Cite><Author>Garber</Author><Year>2011</Year><RecNum>2578</RecNum><IDText>American College of Sports Medicine position stand. Quantity and quality of exercise for developing and maintaining cardiorespiratory, musculoskeletal, and neuromotor fitness in apparently healthy adults: guidance for prescribing exercise</IDText><DisplayText>[18]</DisplayText><record><rec-number>2578</rec-number><foreign-keys><key app="EN" db-id="50wxdpzd9vd5r7e9t5b595djrfpttrxw9avp" timestamp="1532620513">2578</key></foreign-keys><ref-type name="Journal Article">17</ref-type><contributors><authors><author>Garber, C. E.</author><author>Blissmer , B.</author><author>Deschenes, M. R.</author><author>Franklin, B. A.</author><author>Lamonte , M. J.</author><author>Lee, I. M.</author><author>Nieman, D. C.</author><author>Swain, D. P.</author></authors></contributors><titles><title>American College of Sports Medicine position stand. Quantity and quality of exercise for developing and maintaining cardiorespiratory, musculoskeletal, and neuromotor fitness in apparently healthy adults: guidance for prescribing exercise</title><secondary-title>Medicine and Science in Sports and Exercise</secondary-title></titles><periodical><full-title>Med Sci Sports Exerc</full-title><abbr-1>Medicine and science in sports and exercise</abbr-1></periodical><pages>1334-1359</pages><volume>43</volume><number>7</number><dates><year>2011</year></dates><urls></urls><electronic-resource-num>10.1249/MSS.0b013e318213fefb.</electronic-resource-num></record></Cite></EndNote>[18]. Participants maintained a cadence of 50 rev·min-1 and each 5 min bout was separated by 2.5 min of active recovery at light resistance (50 W). As patients became accustomed to the exercise, they were encouraged to progress towards the upper threshold of intensity by adding further load to the cycle ergometer flywheel. The resistance training component included six exercises that targeted the major muscle groups (dumbbell squat, modified press-up, dumbbell bent-over row, dumbbell bicep curl, short arc quad, wall squat). Participants performed 2-4 sets of 10 repetitions at 11-15 RPE, which is a valid method of monitoring resistance training intensity in this population PEVuZE5vdGU+PENpdGU+PEF1dGhvcj5GYWlybWFuPC9BdXRob3I+PFllYXI+MjAxODwvWWVhcj48
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ADDIN EN.CITE.DATA [20]. Waist and hip circumferences were measured with a non-stretching anthropometric tape using standard techniques ADDIN EN.CITE <EndNote><Cite><Author>WHO</Author><Year>2008</Year><RecNum>2865</RecNum><IDText>Waist circumference and waist–hip ratio: report of a WHO expert consultation</IDText><DisplayText>[21]</DisplayText><record><rec-number>2865</rec-number><foreign-keys><key app="EN" db-id="50wxdpzd9vd5r7e9t5b595djrfpttrxw9avp" timestamp="1532620603">2865</key></foreign-keys><ref-type name="Book">6</ref-type><contributors><authors><author>WHO</author></authors></contributors><titles><title>Waist circumference and waist–hip ratio: report of a WHO expert consultation</title></titles><dates><year>2008</year></dates><pub-location>Geneva, Switzerland</pub-location><publisher>World Health Organisation</publisher><urls></urls></record></Cite></EndNote>[21]. Cardiopulmonary fitnessAn incremental cardiopulmonary exercise test (CPET) was performed on an electronically braked cycle ergometer (Excalibur Sport, Lode, Netherlands) to determine maximum exercise tolerance. Following a warm-up against no added resistance, work rate was increased by 10-20 W·min-1 to volitional exhaustion. Breath-by-breath data were recorded throughout (Ultima, CardioO2; Medical Graphics Corporation) and averaged before interpretation using a moving average (middle five of seven breaths). Peak oxygen consumption (V?O2peak) was determined as the highest [moving average] V?O2 attained during the CPET. Peak effort was confirmed by a peak respiratory exchange ratio of > 1.10 and/or a peak heart rate within 10 beats min-1 of age-predicted maximum. The ventilatory threshold (VT) was estimated using the modified V-slope method PEVuZE5vdGU+PENpdGU+PEF1dGhvcj5MZXZldHQ8L0F1dGhvcj48WWVhcj4yMDE4PC9ZZWFyPjxJ
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ADDIN EN.CITE.DATA [22], which was confirmed by evaluating ventilatory equivalents and end-tidal pressures . Two analysts independently determined VT, with discrepancies of ≥ 7.5% resolved through discussion and consultation with a third analyst, if necessary. Ventilatory equivalents for O2 (V?E/V?O2) and CO2 (V?E/V?CO2) at VT, O2 pulse at peak exercise, and oxygen uptake efficiency slope (OUES) were also derived. BiomarkersFasting blood samples were assessed for insulin, glucose, total cholesterol, low-density lipoprotein cholesterol (LDL-C), high-density lipoprotein cholesterol (HDL-C), triglycerides, prostate specific antigen (PSA), testosterone and sex hormone binding globulin (SHBG) in the hospital’s accredited clinical biochemistry laboratory. The baseline sample was taken before the initial LHRH agonist injection. Cardiovascular event riskThe risk of a cardiovascular event in the next 10 years was estimated with the validated QRISK2 online calculator () ADDIN EN.CITE <EndNote><Cite><Author>Collins</Author><Year>2010</Year><RecNum>0</RecNum><IDText>An independent and external validation of QRISK2 cardiovascular disease risk score: a prospective open cohort study</IDText><DisplayText>[23]</DisplayText><record><dates><pub-dates><date>May 13</date></pub-dates><year>2010</year></dates><keywords><keyword>Adult</keyword><keyword>Aged</keyword><keyword>Cardiovascular Diseases/epidemiology/*prevention & control</keyword><keyword>Family Practice</keyword><keyword>Female</keyword><keyword>Humans</keyword><keyword>Incidence</keyword><keyword>Male</keyword><keyword>Middle Aged</keyword><keyword>Prospective Studies</keyword><keyword>Risk Assessment/standards</keyword><keyword>Risk Factors</keyword><keyword>Sensitivity and Specificity</keyword><keyword>United Kingdom/epidemiology</keyword></keywords><isbn>0959-8138</isbn><custom2>PMC2869403</custom2><titles><title>An independent and external validation of QRISK2 cardiovascular disease risk score: a prospective open cohort study</title><secondary-title>Bmj</secondary-title></titles><pages>c2442</pages><contributors><authors><author>Collins, G. S.</author><author>Altman, D. G.</author></authors></contributors><edition>2010/05/15</edition><language>eng</language><added-date format="utc">1562322472</added-date><ref-type name="Journal Article">17</ref-type><auth-address>Centre for Statistics in Medicine, Wolfson College Annexe, University of Oxford, Oxford OX2 6UD. gary.collins@csm.ox.ac.uk</auth-address><remote-database-provider>NLM</remote-database-provider><rec-number>6630</rec-number><last-updated-date format="utc">1562322472</last-updated-date><accession-num>20466793</accession-num><electronic-resource-num>10.1136/bmj.c2442</electronic-resource-num><volume>340</volume></record></Cite></EndNote>[23]. Hand grip strengthHand grip strength was measured with an analogue dynamometer (Takei Scientific Instruments Ltd., Tokyo, Japan). Participants performed three maximal trials on each hand, with the highest score used for analysis. Patient reported outcomes (PROs) and self-reported activityThe Functional Assessment of Cancer Therapy-Prostate (FACT-P) questionnaire assessed disease-specific QoL. Fatigue was measured with Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-Fatigue) questionnaire. Higher scores indicate better QoL and less fatigue, respectively. The Godin Leisure-Time Exercise Questionnaire (GodinQ) was used to characterise self-reported levels of physical activity ADDIN EN.CITE <EndNote><Cite><Author>Motl</Author><Year>2018</Year><RecNum>3387</RecNum><IDText>Validation of the Godin Leisure-Time Exercise Questionnaire classification coding system using accelerometry in multiple sclerosis</IDText><DisplayText>[24]</DisplayText><record><rec-number>3387</rec-number><foreign-keys><key app="EN" db-id="50wxdpzd9vd5r7e9t5b595djrfpttrxw9avp" timestamp="1553091319">3387</key></foreign-keys><ref-type name="Journal Article">17</ref-type><contributors><authors><author>Motl, R. W.</author><author>Bollaert, R. E.</author><author>Sandroff, B. M.</author></authors></contributors><auth-address>Department of Physical Therapy, School of Health Professions, University of Alabama at Birmingham.
Department of Kinesiology and Community Health, University of Illinois at Urbana-Champaign.</auth-address><titles><title>Validation of the Godin Leisure-Time Exercise Questionnaire classification coding system using accelerometry in multiple sclerosis</title><secondary-title>Rehabil Psychol</secondary-title></titles><periodical><full-title>Rehabil Psychol</full-title></periodical><pages>77-82</pages><volume>63</volume><number>1</number><edition>2017/08/02</edition><keywords><keyword>Accelerometry/*methods</keyword><keyword>*Exercise</keyword><keyword>Female</keyword><keyword>Humans</keyword><keyword>*Leisure Activities</keyword><keyword>Male</keyword><keyword>Middle Aged</keyword><keyword>Multiple Sclerosis/*rehabilitation</keyword><keyword>Reproducibility of Results</keyword><keyword>Sedentary Behavior</keyword><keyword>Surveys and Questionnaires/*standards</keyword></keywords><dates><year>2018</year><pub-dates><date>Feb</date></pub-dates></dates><isbn>0090-5550</isbn><accession-num>28758772</accession-num><urls></urls><electronic-resource-num>10.1037/rep0000162</electronic-resource-num><remote-database-provider>NLM</remote-database-provider><language>eng</language></record></Cite></EndNote>[24]. Sample sizeThe primary outcome was difference in body fat mass at 3-months. This was chosen because adiposity has shown a high propensity to increase during the initial phases of ADT, more so than other measures PEVuZE5vdGU+PENpdGU+PEF1dGhvcj5HYWx2YW88L0F1dGhvcj48WWVhcj4yMDExPC9ZZWFyPjxS
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ADDIN EN.CITE.DATA [11] is the only previous study to have investigated the effects of exercise in prostate cancer patients initiating ADT, reporting an adjusted mean difference in body fat mass of 1.4 kg (p = 0.001) at 3-months. An SD of 1.6 kg was obtained from the adjusted mean difference and p-value using Cochrane guidelines ADDIN EN.CITE <EndNote><Cite><Author>Higgins</Author><Year>2011</Year><RecNum>3180</RecNum><IDText>Chapter 7: Selecting studies and collecting data</IDText><DisplayText>[26]</DisplayText><record><rec-number>3180</rec-number><foreign-keys><key app="EN" db-id="50wxdpzd9vd5r7e9t5b595djrfpttrxw9avp" timestamp="1532620680">3180</key></foreign-keys><ref-type name="Book Section">5</ref-type><contributors><authors><author>Higgins, J.P.T.</author><author>Green, S.</author></authors><secondary-authors><author>Higgins, J.P.T.</author><author>Deeks, J.J.</author></secondary-authors></contributors><titles><title>Chapter 7: Selecting studies and collecting data</title><secondary-title>Cochrane Handbook for Systematic Reviews of Interventions? Version 5.1.0 (updated March 2011)</secondary-title></titles><dates><year>2011</year></dates><publisher>The Cochrane Collaboration.? Available from handbook..</publisher><urls></urls></record></Cite></EndNote>[26]. Therefore, 44 participants (22 per group) were required to detect a between-group difference of 1.4 kg assuming SD = 1.6 kg, numerator df = 1, ? = 0.05 and 1-β = 0.8, which was calculated using G*Power version 3.1. An attrition rate of 20% was also factored into the sample size calculation. Statistical analysisAnalyses were performed by intention to treat using R (R Foundation for Statistical Computing, Vienna, Austria). Between-group differences in outcomes at 3-months and 6-months were assessed by analysis of covariance (ANCOVA), with baseline values as covariates. The adjusted mean differences with 95% confidence intervals are presented. Statistical significance was set at a two-tailed p < 0.05. To comply with intention to treat and increase precision of the estimates, missing data at 3-months (n = 8) and 6-months (n = 13) were multiply imputed using predictive mean matching with 20 iterations. At the end of the 20 iterations, one imputed data set was created and the process was repeated to generate 20 imputed data sets. ANCOVA models were fitted on each imputed data set, and the results from each model were then pooled into a single set of estimates and standard errors using Rubin’s rules ADDIN EN.CITE <EndNote><Cite><Author>Zhang</Author><Year>2016</Year><RecNum>3440</RecNum><IDText>Multiple imputation with multivariate imputation by chained equation (MICE) package</IDText><DisplayText>[27]</DisplayText><record><rec-number>3440</rec-number><foreign-keys><key app="EN" db-id="50wxdpzd9vd5r7e9t5b595djrfpttrxw9avp" timestamp="1563871967">3440</key></foreign-keys><ref-type name="Journal Article">17</ref-type><contributors><authors><author>Zhang, Z.</author></authors></contributors><auth-address>Department of Critical Care Medicine, Jinhua Municipal Central Hospital, Jinhua Hospital of Zhejiang University, Jinhua 321000, China.</auth-address><titles><title>Multiple imputation with multivariate imputation by chained equation (MICE) package</title><secondary-title>Ann Transl Med</secondary-title></titles><periodical><full-title>Ann Transl Med</full-title></periodical><pages>30</pages><volume>4</volume><number>2</number><edition>2016/02/19</edition><keywords><keyword>Big-data clinical trial</keyword><keyword>R</keyword><keyword>imputed complete dataset</keyword><keyword>multiple imputation (MI)</keyword><keyword>multivariate imputation by chained equation (MICE) package</keyword></keywords><dates><year>2016</year><pub-dates><date>Jan</date></pub-dates></dates><isbn>2305-5839 (Print)
2305-5839</isbn><accession-num>26889483</accession-num><urls></urls><custom2>PMC4731595</custom2><electronic-resource-num>10.3978/j.issn.2305-5839.2015.12.63</electronic-resource-num><remote-database-provider>NLM</remote-database-provider><language>eng</language></record></Cite></EndNote>[27]. For participants who had missing data at 3-months, baseline values and other covariates were entered into the imputation model. When data were missing at 6-months, baseline and 3-month endpoint values with covariates were used to impute missing values. Outcomes with missing data at baseline were not included in the analysis. Data and analyses scripts can be accessed online ADDIN EN.CITE <EndNote><Cite><Author>Orange</Author><Year>2019</Year><IDText>Dataset: PROState Cancer Patients Initiating Hormone Therapy: Effect of Exercise on CARDIOvascular Health (PROSCARDIO)</IDText><DisplayText>[28]</DisplayText><record><titles><title>Dataset: PROState Cancer Patients Initiating Hormone Therapy: Effect of Exercise on CARDIOvascular Health (PROSCARDIO)</title></titles><contributors><authors><author>Orange, S.T.</author><author>Ndjavera, W.</author><author>O’Doherty, A.F.</author><author>Leicht, A.S.</author><author>Rochester, M.</author><author>Mills, R.</author><author>Saxton, J.M.</author></authors></contributors><edition>1</edition><added-date format="utc">1565008207</added-date><pub-location>Open Science Framework</pub-location><ref-type name="Dataset">59</ref-type><dates><year>2019</year></dates><rec-number>6654</rec-number><last-updated-date format="utc">1565008401</last-updated-date><electronic-resource-num>10.17605/OSF.IO/KWCH5</electronic-resource-num></record></Cite></EndNote>[28].ResultsRecruitment, retention and adherence to the interventionOf the 186 prostate cancer patients screened for eligibility, 39 were excluded due to bone metastasis or medical conditions limiting exercise. A further 97 patients declined to participate citing various reasons such as work commitments and fearing that treatment might be delayed because they had to complete baseline testing before receiving the ADT injection. Hence, 50 patients enrolled on the study and were randomised (Figure 1). At 3-months, two patients in the exercise group and two in the control group withdrew from the study due to a lack of motivation/interest. Four patients in the control group also missed the 3-month assessment time point due to conflicting schedules. A total of 13 patients missed the assessment at 6-months. All patients in the exercise group completed at least 17 out of a possible 24 supervised sessions (≥ 70%). There were no adverse events reported during training or testing. Patient characteristicsDemographic and medical characteristics at baseline were evenly distributed between groups (Table 1). The mean age of participants was 72 years, with a range of 63 to 79 years. On average, patients were overweight (i.e. BMI ≥ 25 kg/m2) and had multiple comorbidities, with hypertension (46%), cardiovascular disease (36%), and musculoskeletal disorders (26%) being the most common. Two patients in the control group (8%) had a coexistent primary cancer (lymphoma and rectal cancer). The most common patient medications were antianginal/antihypertensive drugs (58%) and statins (52%). The incidence of metastasis at baseline was 42% and the majority of participants had a Gleason score of 7-8 (52%). The average risk of having a cardiovascular event in the next 10 years was 26.8%. Outcomes at each time point are presented in Table 2. Outcomes at 3-monthsExercise prevented the decline in cardiopulmonary fitness, with significant between-group differences found in V?O2peak, VT, and OUES (Table 3). Exercise also prevented the increase in fatigue observed in the control group, as indicated by a significantly higher FACIT-Fatigue score. As expected, serum testosterone concentrations declined in both groups (indicative of severe hypogonadism), which was accompanied by reductions in PSA (Table 2). There was no evidence for differences in blood-borne biomarkers, body composition, cardiovascular disease risk, or hand grip strength (Table 3). Outcomes at 6-monthsAfter the withdrawal of supervision, the exercise group maintained self-directed levels of exercise, as evidenced by the between-group difference in GodinQ (Table 3). Despite this, the significant between-group differences in cardiorespiratory and fatigue observed at 3-months were not maintained (Table 3). However, the exercise group reported higher QoL at 6-months compared to controls. Exercise also prevented adverse changes in QRISK2 score (Table 3), indicating a reduced cardiovascular event risk compared to the control group. There was no evidence for differences in blood-borne biomarkers, body composition, or hand grip strength (Table 3).DiscussionThis is the first study to assess whether the effects of supervised exercise in prostate cancer patients beginning ADT can be maintained after the withdrawal of supervision. The 3-month aerobic and resistance training intervention prevented adverse changes in cardiorespiratory fitness and fatigue. After the supervised exercise was withdrawn, differences in cardiorespiratory fitness and fatigue were not sustained, but the exercise group showed higher QoL and a reduced cardiovascular event risk compared to the control group. These findings have important implications for clinicians concerned with the management of ADT-related side-effects. Our data showed no evidence for an effect of exercise on fat mass in men commencing ADT, which was our primary outcome. Although the adjusted mean difference favoured the exercise group at 3-months (-1.9. kg), the 95% confidence intervals showed that true mean difference is likely to lie somewhere between -4.9 to 0.9 kg, indicating a high level of uncertainty. The current literature-base is equivocal with regard to the effect of exercise on adiposity in hypogonadal men. Segal et al. PEVuZE5vdGU+PENpdGU+PEF1dGhvcj5TZWdhbDwvQXV0aG9yPjxZZWFyPjIwMDk8L1llYXI+PFJl
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ADDIN EN.CITE.DATA [31-34]. Thus, our findings are in line with the existing evidence-base showing an uncertain effect of short-term exercise programmes on body fat. Further research should explore the inclusion of other strategies alongside exercise (e.g. calorie restriction) to promote meaningful reductions in fat mass in prostate cancer patients receiving ADT. Supervised exercise prevented the reduction in cardiorespiratory fitness observed in the controls, with significant differences in V?O2peak, VT and OUES favouring the exercise group at 3-months. The adjusted mean difference in V?O2peak (1.9 ml.kg-1.min-1) was of a similar magnitude to that reported previously in prostate cancer patients after 3-months of aerobic and resistance training at the commencement of ADT (1.1 ml.kg-1.min-1) PEVuZE5vdGU+PENpdGU+PEF1dGhvcj5Db3JtaWU8L0F1dGhvcj48WWVhcj4yMDE1PC9ZZWFyPjxS
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ADDIN EN.CITE.DATA [11]. Although the minimal clinically important difference (MCID) in V?O2peak for prostate cancer patients is currently unknown, an increase of 1.8 ml.kg-1.min-1 following 6-months of exercise training has been associated with improved PSA doubling time (R2 = 0.41, p < 0.003) PEVuZE5vdGU+PENpdGU+PEF1dGhvcj5IdmlkPC9BdXRob3I+PFllYXI+MjAxNjwvWWVhcj48UmVj
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ADDIN EN.CITE.DATA [35]. This finding suggests a link between improved cardiopulmonary exercise capacity and prostate cancer progression, which is consistent with the reported inverse relationship between vigorous physical activity and biochemical recurrence in newly diagnosed prostate cancer patients ADDIN EN.CITE <EndNote><Cite><Author>Richman</Author><Year>2011</Year><RecNum>3366</RecNum><DisplayText>[36]</DisplayText><record><rec-number>3366</rec-number><foreign-keys><key app="EN" db-id="50wxdpzd9vd5r7e9t5b595djrfpttrxw9avp" timestamp="1548426374">3366</key></foreign-keys><ref-type name="Journal Article">17</ref-type><contributors><authors><author>Richman, E. L.</author><author>Kenfield, S. A.</author><author>Stampfer, M. J.</author><author>Paciorek, A.</author><author>Carroll, P. R.</author><author>Chan, J. M.</author></authors></contributors><auth-address>Department of Epidemiology, Harvard School of Public Health, Boston, Massachusetts, USA.</auth-address><titles><title>Physical activity after diagnosis and risk of prostate cancer progression: data from the cancer of the prostate strategic urologic research endeavor</title><secondary-title>Cancer Res</secondary-title><alt-title>Cancer research</alt-title></titles><periodical><full-title>Cancer Res</full-title><abbr-1>Cancer research</abbr-1></periodical><alt-periodical><full-title>Cancer Res</full-title><abbr-1>Cancer research</abbr-1></alt-periodical><pages>3889-95</pages><volume>71</volume><number>11</number><edition>2011/05/26</edition><keywords><keyword>Aged</keyword><keyword>Disease Progression</keyword><keyword>Exercise/*physiology</keyword><keyword>Humans</keyword><keyword>Male</keyword><keyword>Middle Aged</keyword><keyword>*Motor Activity</keyword><keyword>Proportional Hazards Models</keyword><keyword>Prospective Studies</keyword><keyword>Prostatic Neoplasms/diagnosis/*pathology</keyword><keyword>Risk Factors</keyword><keyword>Surveys and Questionnaires</keyword></keywords><dates><year>2011</year><pub-dates><date>Jun 1</date></pub-dates></dates><isbn>0008-5472</isbn><accession-num>21610110</accession-num><urls></urls><custom2>PMC3107352</custom2><custom6>NIHMS290316</custom6><electronic-resource-num>10.1158/0008-5472.Can-10-3932</electronic-resource-num><remote-database-provider>NLM</remote-database-provider><language>eng</language></record></Cite></EndNote>[36]. Other evidence also suggests that cardiopulmonary fitness is associated with reduced relative risk of cancer mortality and chronic disease PEVuZE5vdGU+PENpdGU+PEF1dGhvcj5TY2htaWQ8L0F1dGhvcj48WWVhcj4yMDE1PC9ZZWFyPjxS
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ZT4A
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ADDIN EN.CITE.DATA [22], and therefore the improvement occurred independent of motivational factors during the CPET. Furthermore, VT is limited by the rate of oxygen utilisation at the muscle as opposed to V?O2peak, which is primarily limited by delivery of oxygen to the muscle ADDIN EN.CITE <EndNote><Cite><Author>Bassett</Author><Year>2000</Year><IDText>Limiting factors for maximum oxygen uptake and determinants of endurance performance</IDText><DisplayText>[40]</DisplayText><record><dates><pub-dates><date>Jan</date></pub-dates><year>2000</year></dates><keywords><keyword>Anaerobic Threshold/physiology</keyword><keyword>Cardiac Output/physiology</keyword><keyword>Heart/physiology</keyword><keyword>Humans</keyword><keyword>Lactic Acid/metabolism</keyword><keyword>Lipid Metabolism</keyword><keyword>Lung/physiology</keyword><keyword>Mitochondria, Muscle/enzymology</keyword><keyword>Muscle, Skeletal/metabolism</keyword><keyword>Oxidation-Reduction</keyword><keyword>Oxygen/blood</keyword><keyword>Oxygen Consumption/*physiology</keyword><keyword>Physical Endurance/*physiology</keyword><keyword>Running/physiology</keyword></keywords><isbn>0195-9131 (Print)
0195-9131</isbn><titles><title>Limiting factors for maximum oxygen uptake and determinants of endurance performance</title><secondary-title>Med Sci Sports Exerc</secondary-title></titles><pages>70-84</pages><number>1</number><contributors><authors><author>Bassett, D. R., Jr.</author><author>Howley, E. T.</author></authors></contributors><edition>2000/01/27</edition><language>eng</language><added-date format="utc">1565000376</added-date><ref-type name="Journal Article">17</ref-type><auth-address>Department of Exercise Science and Sport Management, University of Tennessee, Knoxville 37996, USA. DBassett@utk.edu</auth-address><remote-database-provider>NLM</remote-database-provider><rec-number>6653</rec-number><last-updated-date format="utc">1565000376</last-updated-date><accession-num>10647532</accession-num><volume>32</volume></record></Cite></EndNote>[40], although this could be influenced by age-related diseases such as sarcopenia. As such, VT represents a unique peripheral muscle adaptation in response to exercise training. The exercise group reported less fatigue than controls at 3-months. The between-group difference in FACIT-Fatigue score (4.5 points) is clinically relevant given that the MCID has been estimated at 3 points PEVuZE5vdGU+PENpdGU+PEF1dGhvcj5Ob3JkaW48L0F1dGhvcj48WWVhcj4yMDE2PC9ZZWFyPjxS
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ADDIN EN.CITE.DATA [43]. The biological mechanisms underpinning the beneficial effects of exercise on fatigue are not completely understood, but may be related to its anti-inflammatory effect on cancer-related systemic inflammation ADDIN EN.CITE <EndNote><Cite><Author>Christensen</Author><Year>2018</Year><RecNum>3384</RecNum><IDText>Exercise Training in Cancer Control and Treatment</IDText><DisplayText>[44]</DisplayText><record><rec-number>3384</rec-number><foreign-keys><key app="EN" db-id="50wxdpzd9vd5r7e9t5b595djrfpttrxw9avp" timestamp="1552304673">3384</key></foreign-keys><ref-type name="Journal Article">17</ref-type><contributors><authors><author>Christensen, J. F.</author><author>Simonsen, C.</author><author>Hojman, P.</author></authors></contributors><auth-address>Centre of Inflammation and Metabolism (CIM) and Centre for Physical Activity Research (CFAS), Copenhagen University Hospital, Copenhagen, Denmark.</auth-address><titles><title>Exercise Training in Cancer Control and Treatment</title><secondary-title>Compr Physiol</secondary-title><alt-title>Comprehensive Physiology</alt-title></titles><periodical><full-title>Compr Physiol</full-title><abbr-1>Comprehensive Physiology</abbr-1></periodical><alt-periodical><full-title>Compr Physiol</full-title><abbr-1>Comprehensive Physiology</abbr-1></alt-periodical><pages>165-205</pages><volume>9</volume><number>1</number><edition>2018/12/15</edition><dates><year>2018</year><pub-dates><date>Dec 13</date></pub-dates></dates><isbn>2040-4603</isbn><accession-num>30549018</accession-num><urls></urls><electronic-resource-num>10.1002/cphy.c180016</electronic-resource-num><remote-database-provider>NLM</remote-database-provider><language>eng</language></record></Cite></EndNote>[44]. An important and novel aspect of this study was the 6-month follow-up after the withdrawal of supervised exercise. This allowed us to determine whether exercise-induced improvements were maintained in the longer-term, which is important because side-effects of ADT continue to develop throughout treatment PEVuZE5vdGU+PENpdGU+PEF1dGhvcj5XYWxsPC9BdXRob3I+PFllYXI+MjAxNTwvWWVhcj48UmVj
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ADDIN EN.CITE.DATA [3] and reductions in physical function occur just 3-months after the cessation of supervised exercise in older adults ADDIN EN.CITE <EndNote><Cite><Author>Orange</Author><Year>2018</Year><RecNum>3193</RecNum><IDText>The Short-Term Training and Detraining Effects of Supervised Versus Unsupervised Resistance Exercise in Aging Adults</IDText><DisplayText>[15]</DisplayText><record><rec-number>3193</rec-number><foreign-keys><key app="EN" db-id="50wxdpzd9vd5r7e9t5b595djrfpttrxw9avp" timestamp="1536137046">3193</key></foreign-keys><ref-type name="Journal Article">17</ref-type><contributors><authors><author>Orange, S. T.</author><author>Marshall, P.</author><author>Madden, L. A.</author><author>Vince, R. V.</author></authors></contributors><titles><title>The Short-Term Training and Detraining Effects of Supervised Versus Unsupervised Resistance Exercise in Aging Adults</title><secondary-title><style face="italic" font="default" size="100%">Journal of strength and conditioning research</style></secondary-title></titles><periodical><full-title>Journal of strength and conditioning research</full-title></periodical><dates><year>2018</year></dates><urls></urls></record></Cite></EndNote>[15]. Despite the maintenance of self-directed exercise, as evidenced by the GodinQ, the exercise-induced improvements in cardiopulmonary fitness and fatigue were not sustained at 6-months. Exercise is often performed at a lower intensity when it is unsupervised compared to when it is performed under supervision ADDIN EN.CITE <EndNote><Cite><Author>Orange</Author><Year>2018</Year><RecNum>3193</RecNum><DisplayText>[15]</DisplayText><record><rec-number>3193</rec-number><foreign-keys><key app="EN" db-id="50wxdpzd9vd5r7e9t5b595djrfpttrxw9avp" timestamp="1536137046">3193</key></foreign-keys><ref-type name="Journal Article">17</ref-type><contributors><authors><author>Orange, S. T.</author><author>Marshall, P.</author><author>Madden, L. A.</author><author>Vince, R. V.</author></authors></contributors><titles><title>The Short-Term Training and Detraining Effects of Supervised Versus Unsupervised Resistance Exercise in Aging Adults</title><secondary-title><style face="italic" font="default" size="100%">Journal of strength and conditioning research</style></secondary-title></titles><periodical><full-title>Journal of strength and conditioning research</full-title></periodical><dates><year>2018</year></dates><urls></urls></record></Cite></EndNote>[15]. As a consequence, the intensity of self-directed exercise after the withdrawal of supervision may have been inadequate to sustain the benefits observed at 3-months, and this would need to be addressed in future research. Despite this, maintaining self-directed exercise after the supervised exercise was withdrawn attenuated the adverse effects that ADT had on QoL. Specifically, the adjusted mean difference (8.5 points) in FACT-P at 6-months favoured the exercise group; a difference that is clinical meaningful PEVuZE5vdGU+PENpdGU+PEF1dGhvcj5DZWxsYTwvQXV0aG9yPjxZZWFyPjIwMDk8L1llYXI+PFJl
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ADDIN EN.CITE.DATA [46]. Secondary to increasing patient longevity, maintaining patient QoL is a key objective for physicians prescribing treatment for diseases such as prostate cancer ADDIN EN.CITE <EndNote><Cite><Author>Albertsen</Author><Year>1997</Year><RecNum>3451</RecNum><IDText>Health-related quality of life among patients with metastatic prostate cancer</IDText><DisplayText>[47]</DisplayText><record><rec-number>3451</rec-number><foreign-keys><key app="EN" db-id="50wxdpzd9vd5r7e9t5b595djrfpttrxw9avp" timestamp="1563871969">3451</key></foreign-keys><ref-type name="Journal Article">17</ref-type><contributors><authors><author>Albertsen, P. C.</author><author>Aaronson, N. K.</author><author>Muller, M. J.</author><author>Keller, S. D.</author><author>Ware Jr, J. E.</author></authors></contributors><titles><title>Health-related quality of life among patients with metastatic prostate cancer</title><secondary-title><style face="italic" font="default" size="100%">Urology</style></secondary-title></titles><periodical><full-title>Urology</full-title></periodical><pages>207-217</pages><volume>49</volume><number>2</number><dates><year>1997</year></dates><urls></urls></record></Cite></EndNote>[47]. Indeed, there have been calls for clinicians to provide supportive care alongside standard therapy to optimise the management of advanced prostate cancer ADDIN EN.CITE <EndNote><Cite><Author>Body</Author><Year>2018</Year><IDText>Medical management of metastatic prostate cancer</IDText><DisplayText>[48]</DisplayText><record><dates><pub-dates><date>Oct</date></pub-dates><year>2018</year></dates><keywords><keyword>abiraterone</keyword><keyword>androgen deprivation therapy</keyword><keyword>chemotherapy</keyword><keyword>docetaxel</keyword><keyword>enzalutamide</keyword><keyword>prostate cancer</keyword><keyword>radium</keyword></keywords><isbn>0312-8008 (Print)
0312-8008</isbn><custom2>PMC6202297</custom2><titles><title>Medical management of metastatic prostate cancer</title><secondary-title>Aust Prescr</secondary-title></titles><pages>154-159</pages><number>5</number><contributors><authors><author>Body, A.</author><author>Pranavan, G.</author><author>Tan, T. H.</author><author>Slobodian, P.</author></authors></contributors><edition>2018/11/10</edition><language>eng</language><added-date format="utc">1564995807</added-date><ref-type name="Journal Article">17</ref-type><auth-address>Department of Medical Oncology, Canberra Hospital.
Australian National University Medical School, Canberra.
Department of Medical Oncology, Royal Adelaide Hospital.
Royal Adelaide Hospital.</auth-address><remote-database-provider>NLM</remote-database-provider><rec-number>6651</rec-number><last-updated-date format="utc">1564995807</last-updated-date><accession-num>30410212</accession-num><electronic-resource-num>10.18773/austprescr.2018.046</electronic-resource-num><volume>41</volume></record></Cite></EndNote>[48]. The findings of this RCT suggest that a short-term programme of supervised exercise training commenced at the beginning of ADT is an effective, non-pharmacological strategy for preventing treatment-related reductions in QoL. Regular exercise also prevented the adverse effect of ADT on cardiovascular events risk, as evidence by the significant difference in QRISK2 score at 6-months (-2.9%, p = 0.041). This is an important finding because ADT increases the risk of acute myocardial infarction in prostate cancer patients PEVuZE5vdGU+PENpdGU+PEF1dGhvcj5UZW9oPC9BdXRob3I+PFllYXI+MjAxNTwvWWVhcj48UmVj
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ADDIN EN.CITE.DATA [50]. Convincing epidemiological evidence also shows an inverse association between regular exercise and risk of an acute cardiovascular event ADDIN EN.CITE <EndNote><Cite><Author>Nystoriak</Author><Year>2018</Year><RecNum>3453</RecNum><IDText>Cardiovascular Effects and Benefits of Exercise</IDText><DisplayText>[51]</DisplayText><record><rec-number>3453</rec-number><foreign-keys><key app="EN" db-id="50wxdpzd9vd5r7e9t5b595djrfpttrxw9avp" timestamp="1563871970">3453</key></foreign-keys><ref-type name="Journal Article">17</ref-type><contributors><authors><author>Nystoriak, M. A.</author><author>Bhatnagar, A.</author></authors></contributors><auth-address>Division of Cardiovascular Medicine, Department of Medicine, Diabetes and Obesity Center, Institute of Molecular Cardiology, University of Louisville, Louisville, KY, United States.</auth-address><titles><title>Cardiovascular Effects and Benefits of Exercise</title><secondary-title>Front Cardiovasc Med</secondary-title></titles><periodical><full-title>Front Cardiovasc Med</full-title></periodical><pages>135</pages><volume>5</volume><edition>2018/10/17</edition><keywords><keyword>atherosclerosis</keyword><keyword>blood flow</keyword><keyword>coronary artery disease</keyword><keyword>endothelium</keyword><keyword>physical activity</keyword></keywords><dates><year>2018</year></dates><isbn>2297-055X (Print)
2297-055x</isbn><accession-num>30324108</accession-num><urls></urls><custom2>PMC6172294</custom2><electronic-resource-num>10.3389/fcvm.2018.00135</electronic-resource-num><remote-database-provider>NLM</remote-database-provider><language>eng</language></record></Cite></EndNote>[51]. Thus, our findings extend those of previous studies by providing preliminary support for exercise as a countermeasure for ADT-related cardiovascular event risk. It should be acknowledged, however, that despite showing a reduction in risk compared to controls, the exercise group still reported a mean QRISK2 score of 25.8% at 6-months, which is considered high risk ADDIN EN.CITE <EndNote><Cite><Author>Collins</Author><Year>2010</Year><RecNum>0</RecNum><IDText>An independent and external validation of QRISK2 cardiovascular disease risk score: a prospective open cohort study</IDText><DisplayText>[23]</DisplayText><record><dates><pub-dates><date>May 13</date></pub-dates><year>2010</year></dates><keywords><keyword>Adult</keyword><keyword>Aged</keyword><keyword>Cardiovascular Diseases/epidemiology/*prevention & control</keyword><keyword>Family Practice</keyword><keyword>Female</keyword><keyword>Humans</keyword><keyword>Incidence</keyword><keyword>Male</keyword><keyword>Middle Aged</keyword><keyword>Prospective Studies</keyword><keyword>Risk Assessment/standards</keyword><keyword>Risk Factors</keyword><keyword>Sensitivity and Specificity</keyword><keyword>United Kingdom/epidemiology</keyword></keywords><isbn>0959-8138</isbn><custom2>PMC2869403</custom2><titles><title>An independent and external validation of QRISK2 cardiovascular disease risk score: a prospective open cohort study</title><secondary-title>Bmj</secondary-title></titles><pages>c2442</pages><contributors><authors><author>Collins, G. S.</author><author>Altman, D. G.</author></authors></contributors><edition>2010/05/15</edition><language>eng</language><added-date format="utc">1562322472</added-date><ref-type name="Journal Article">17</ref-type><auth-address>Centre for Statistics in Medicine, Wolfson College Annexe, University of Oxford, Oxford OX2 6UD. gary.collins@csm.ox.ac.uk</auth-address><remote-database-provider>NLM</remote-database-provider><rec-number>6630</rec-number><last-updated-date format="utc">1562322472</last-updated-date><accession-num>20466793</accession-num><electronic-resource-num>10.1136/bmj.c2442</electronic-resource-num><volume>340</volume></record></Cite></EndNote>[23].There were some limitations to this study. The intervention involved a 3-month programme of supervised exercise led by exercise specialists, which may not be deliverable within healthcare systems. In addition, the trial was only powered to detect differences in fat mass and may not have been adequately powered to detect differences in some of the secondary outcomes. Furthermore, using self-report questionnaires to assess physical activity can be prone to subjective bias, although anecdotal evidence from the patients helped confirm that the exercise group maintained self-directed exercise after the supervised exercise intervention was withdrawn.In conclusion, 3-months of supervised aerobic and resistance training followed by 3-months of self-directed exercise provided a sustained benefit to QoL and cardiovascular event risk in prostate cancer patients commencing ADT. Our results suggest that clinicians could prescribe a short-term exercise programme at the beginning of ADT to attenuate these important treatment-related side-effects. AcknowledgementsThe authors would like to thank all participants for volunteering to take part in this study. Conflicts of interest statementThe authors have no potential conflicts of interest to discloseReferences ADDIN EN.REFLIST [1]Pagliarulo V, Bracarda S, Eisenberger MA, et al. Contemporary role of androgen deprivation therapy for prostate cancer. Eur Urol. 2012 Jan: 61:11-25[2]Spry NA, Taaffe DR, England PJ, et al. Long-term effects of intermittent androgen suppression therapy on lean and fat mass: a 33-month prospective study. Prostate Cancer Prostatic Dis. 2013 Mar: 16:67-72[3]Wall BA, Galvao DA, Fatehee N, et al. Reduced Cardiovascular Capacity and Resting Metabolic Rate in Men with Prostate Cancer Undergoing Androgen Deprivation: A Comprehensive Cross-Sectional Investigation. Adv Urol. 2015: 2015:976235[4]Gonzalez BD, Jim HSL, Small BJ, et al. Changes in physical functioning and muscle strength in men receiving androgen deprivation therapy for prostate cancer: a controlled comparison. Support Care Cancer. 2016 May: 24:2201-7[5]Nelson AM, Gonzalez BD, Jim HS, et al. 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Exercise overcome adverse effects among prostate cancer patients receiving androgen deprivation therapy: An update meta-analysis. Medicine. 2017 Jul: 96:e7368[11]Cormie P, Galvao DA, Spry N, et al. Can supervised exercise prevent treatment toxicity in patients with prostate cancer initiating androgen-deprivation therapy: a randomised controlled trial. BJU Int. 2015 Feb: 115:256-66[12]Alibhai SM, Breunis H, Timilshina N, et al. Impact of androgen-deprivation therapy on physical function and quality of life in men with nonmetastatic prostate cancer. J Clin Oncol. 2010 Dec 1: 28:5038-45[13]Spry NA, Galvao DA, Davies R, et al. Long-term effects of intermittent androgen suppression on testosterone recovery and bone mineral density: results of a 33-month observational study. BJU Int. 2009 Sep: 104:806-12[14]Smith MR, Saad F, Egerdie B, et al. Sarcopenia during androgen-deprivation therapy for prostate cancer. 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Monitoring Resistance Exercise Intensity Using Ratings of Perceived Exertion in Previously Untrained Patients With Prostate Cancer Undergoing Androgen Deprivation Therapy. J Strength Cond Res. 2018 May: 32:1360-5[20]Savastano S, Belfiore A, Di Somma C, et al. Validity of bioelectrical impedance analysis to estimate body composition changes after bariatric surgery in premenopausal morbidly women. Obes Surg. 2010 Mar: 20:332-9[21]WHO. Waist circumference and waist–hip ratio: report of a WHO expert consultation, Geneva, Switzerland: World Health Organisation, 2008 Dec 8-11.[22]Levett DZH, Jack S, Swart M, et al. Perioperative cardiopulmonary exercise testing (CPET): consensus clinical guidelines on indications, organization, conduct, and physiological interpretation. Br J Anaesth. 2018 Mar: 120:484-500[23]Collins GS, Altman DG. An independent and external validation of QRISK2 cardiovascular disease risk score: a prospective open cohort study. 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OSF, v1; 2019; doi: 10.17605/OSF.IO/KWCH5.[29]Segal RJ, Reid RD, Courneya KS, et al. Randomized controlled trial of resistance or aerobic exercise in men receiving radiation therapy for prostate cancer. J Clin Oncol. 2009 Jan 20: 27:344-51[30]Dawson JK, Dorff TB, Todd Schroeder E, Lane CJ, Gross ME, Dieli-Conwright CM. Impact of resistance training on body composition and metabolic syndrome variables during androgen deprivation therapy for prostate cancer: a pilot randomized controlled trial. BMC Cancer. 2018 Apr 3: 18:368[31]Bourke L, Doll H, Crank H, Daley A, Rosario D, Saxton JM. Lifestyle intervention in men with advanced prostate cancer receiving androgen suppression therapy: a feasibility study. Cancer Epidemiol Biomarkers Prev. 2011 Apr: 20:647-57[32]Galvao DA, Taaffe DR, Spry N, Joseph D, Newton RU. Combined resistance and aerobic exercise program reverses muscle loss in men undergoing androgen suppression therapy for prostate cancer without bone metastases: a randomized controlled trial. J Clin Oncol. 2010 Jan 10: 28:340-7[33]Galvao DA, Taaffe DR, Spry N, et al. Exercise Preserves Physical Function in Prostate Cancer Patients with Bone Metastases. Med Sci Sports Exerc. 2018 Mar: 50:393-9[34]Segal RJ, Reid RD, Courneya KS, et al. Resistance exercise in men receiving androgen deprivation therapy for prostate cancer. J Clin Oncol. 2003 May 1: 21:1653-9[35]Hvid LG, Strotmeyer ES, Skjodt M, Magnussen LV, Andersen M, Caserotti P. Voluntary muscle activation improves with power training and is associated with changes in gait speed in mobility-limited older adults - A randomized controlled trial. Exp Gerontol. 2016 Jul: 80:51-6[36]Richman EL, Kenfield SA, Stampfer MJ, Paciorek A, Carroll PR, Chan JM. Physical activity after diagnosis and risk of prostate cancer progression: data from the cancer of the prostate strategic urologic research endeavor. Cancer Res. 2011 Jun 1: 71:3889-95[37]Schmid D, Leitzmann MF. Cardiorespiratory fitness as predictor of cancer mortality: a systematic review and meta-analysis. Ann Oncol. 2015 Feb: 26:272-8[38]Aspenes ST, Nilsen TI, Skaug EA, et al. Peak oxygen uptake and cardiovascular risk factors in 4631 healthy women and men. Med Sci Sports Exerc. 2011 Aug: 43:1465-73[39]West MA, Lythgoe D, Barben CP, et al. Cardiopulmonary exercise variables are associated with postoperative morbidity after major colonic surgery: a prospective blinded observational study. Br J Anaesth. 2014 Apr: 112:665-71[40]Bassett DR, Jr., Howley ET. Limiting factors for maximum oxygen uptake and determinants of endurance performance. Med Sci Sports Exerc. 2000 Jan: 32:70-84[41]Nordin A, Taft C, Lundgren-Nilsson A, Dencker A. Minimal important differences for fatigue patient reported outcome measures-a systematic review. BMC Med Res Methodol. 2016 May 26: 16:62[42]Gardner JR, Livingston PM, Fraser SF. Effects of exercise on treatment-related adverse effects for patients with prostate cancer receiving androgen-deprivation therapy: a systematic review. J Clin Oncol. 2014 Feb 1: 32:335-46[43]Fuller JT, Hartland MC, Maloney LT, Davison K. Therapeutic effects of aerobic and resistance exercises for cancer survivors: a systematic review of meta-analyses of clinical trials. Br J Sports Med. 2018 Oct: 52:1311[44]Christensen JF, Simonsen C, Hojman P. Exercise Training in Cancer Control and Treatment. Compr Physiol. 2018 Dec 13: 9:165-205[45]Cella D, Nichol MB, Eton D, Nelson JB, Mulani P. Estimating clinically meaningful changes for the Functional Assessment of Cancer Therapy--Prostate: results from a clinical trial of patients with metastatic hormone-refractory prostate cancer. Value Health. 2009 Jan-Feb: 12:124-9[46]Teleni L, Chan RJ, Chan A, et al. Exercise improves quality of life in androgen deprivation therapy-treated prostate cancer: systematic review of randomised controlled trials. Endocr Relat Cancer. 2016 Feb: 23:101-12[47]Albertsen PC, Aaronson NK, Muller MJ, Keller SD, Ware Jr JE. Health-related quality of life among patients with metastatic prostate cancer. Urology. 1997: 49:207-17[48]Body A, Pranavan G, Tan TH, Slobodian P. Medical management of metastatic prostate cancer. Aust Prescr. 2018 Oct: 41:154-9[49]Teoh JY, Chan SY, Chiu PK, et al. Risk of acute myocardial infarction after androgen-deprivation therapy for prostate cancer in a Chinese population. BJU Int. 2015 Sep: 116:382-7[50]Lee K, Tripathy D, Demark-Wahnefried W, et al. Effect of Aerobic and Resistance Exercise Intervention on Cardiovascular Disease Risk in Women With Early-Stage Breast Cancer: A Randomized Clinical Trial. JAMA Oncol. 2019 Mar 28: [51]Nystoriak MA, Bhatnagar A. Cardiovascular Effects and Benefits of Exercise. Front Cardiovasc Med. 2018: 5:135Figure legendsFigure 1. Participant flowchart. FACT-P = Functional Assessment of Cancer Therapy-Prostate; FFM = fat-free mass; PSA = protein specific antigen; SHBG = sex hormone binding globulin; VT = ventilatory threshold. Table 1. Baseline characteristicsExercise (n = 24)Control (n = 26)Total (n = 50)Age (years)71.4 ± 5.472.5 ± 4.272.0 ± 4.8Body mass (kg)84.0 ± 11.283.8 ± 9.683.9 ± 10.3BMI (kg/m2)28.4 ± 3.127.7 ± 3.428.0 ± 3.3Gleason score ≤ 62 (8)0 (0)2 (4) 7-813 (54)13 (50)26 (52) 9-109 (38)13 (50)22 (44)PSA (ng/mL)23.7 [16, 38]18.3 [11, 75]20.3 [14, 63]Tumour grade Locally advanced11 (46)8 (31)19 (38) Metastatic11 (46) 10 (38)21 (42)Past smoker9 (38)10 (38)19 (38)Current smoker4 (17)2 (8)6 (12)QRISK?2 (%)27.6 ± 10.826.0 ± 7.626.8 ± 9.2Number of comorbidities2.2 ± 1.6 2.9 ± 1.82.6 ± 1.7 Cardiovascular disease8 (33)10 (38)18 (36) Type 2 diabetes4 (17)2 (8)6 (12) Hypertension10 (42)13 (50)23 (46) Hyperlipidaemia4 (17)7 (27)11 (22) Lung disease3 (13)5 (19)8 (16) Kidney disease2 (8)4 (15)6 (12) Coexistent primary cancer0 (0)2 (8)2 (4) MSK disorder7 (29)6 (23)13 (26) Erectile dysfunction2 (8)2 (8)4 (8) GORD3 (13)4 (15)7 (14)Number of medications3.5 ± 3.24.0 ± 3.03.8 ± 3.1 Antianginal/antihypertensive114 (58)15 (58)29 (58) Antidiabetic4 (17)2 (8)6 (12) Antithrombotic5 (21)2 (8)7 (14) Statin10 (42)16 (62)26 (52) Acid reducer3 (13)11 (42)14 (28) Anti-inflammatory7 (29)11 (42)18 (36) Anti-depressant2 (8)5 (19)7 (14)BMI = body mass index; GORD = gastro-oesophageal reflux disease; MSK = musculoskeletal; PSA = prostate specific antigen; SHGB = sex hormone binding globulin. Data are presented as mean ± SD, median [IQR], or number of participants (percentage of participants). 1?-blockers, β-blockers, angiotensin II receptor blockers, diuretics, nitrates, calcium channel blockers, or ?CE inhibitors.Table 2. Outcomes at baseline, 3-months and 6-monthsExercise (n = 24)Control (n = 26)Baseline3-months6-monthsBaseline3-months6-monthsBody compositionFat mass (kg)24.3 ± 5.321.7 ± 7.4 22.7 ± 6.823.3 ± 8.322.7 ± 7.7 24.1 ± 7.6FFM (kg)58.2 ± 7.1 58.9 ± 5.759.3 ± 6.759.1 ± 7.358.2 ± 5.458.2 ± 6.9 Body mass (kg)84.0 ± 11.282.2 ± 10.782.1 ± 10.183.8 ± 9.682.9 ± 9.783.9 ± 9.3Waist circumference (cm)107 ± 11 108 ± 8108 ± 7106 ±7107 ± 8110 ± 8Waist to hip ratio1.03 ± 0.061.02 ± 0.051.03 ± 0.05 0.99 ± 0.051.02 ± 0.051.02 ± 0.06Blood biomarkersPSA (ng/mL)25.8 [25.7]1.8 [2.5]0.53 [1.4]18.3 [63.5]0.9 [3.1]0.41 [2.0]Total cholesterol (mmol/L)4.7 ± 0.984.9 ± 0.85 5.1 ± 0.91 4.9 ± 0.955.0 ± 1.15.2 ± 0.99HDL-C (mmol/L)1.2 ± 0.23 1.3 ± 0.20 1.3 ± 0.221.3 ± 0.291.3 ± 0.281.4 ± 0.34LDL-C (mmol/L)2.9 ± 0.943.0 ± 0.783.2 ± 0.943.0 ± 0.863.1 ± 0.943.2 ± 0.94Triglycerides (mmol/L)1.3 ± 0.611.3 ± 0.561.4 ± 0.451.3 ± 0.561.3 ± 0.641.3 ± 0.54Testosterone (nmol/L)15.1 ± 5.40.57 ± 0.480.45 ± 0.2814.8 ± 6.60.43 ± 0.380.31 ± 0.19SHBG (nmol/L)41.5 [16.8] 46.1 [26.7]51.0 [28.9]41.0 [16.5]47.8 [29.0]45.6 [23.3]Insulin (pmol/L)65.0 [63.0]74.8 [60.5]60.9 [65.4]61.0 [105]63.9 [67.7]90 [94.7]Glucose (mmol/L)5.6 [0.63]5.6 [1.3]5.8 [0.92]5.9 [1.1]5.8 [1.0]5.7 [0.74]PROsFACT-P119 ± 19123 ± 22126 ± 15123 ± 16123 ± 19120 ± 16FACIT-Fatigue41.8 ± 10.241.8 ± 11.243.7 ± 8.642.9 ± 8.438.5 ± 11.939.9 ± 9.3GodinQ29.0 ± 20.943.7 ± 21.940.0 ± 19.832.0 ± 26.336.0 ± 21.331.3 ± 19.3CPET variablesV?O2peak (ml.kg-1.min-1)23.5 ± 5.423.2 ± 5.121.9 ± 4.8 22.4 ± 5.8 20.4 ± 5.320.2 ± 4.7VT (ml.kg-1.min-1)12.1 ± 2.213.1 ± 2.4 11.8 ± 1.811.9 ± 2.211.3 ± 2.211.1 ± 2.3V?E/VCO230.4 ± 4.3 30.4 ± 3.330.9 ± 3.7 31.3 ± 4.6 33.0 ± 4.933.2 ± 4.6V?E/VO227.7 ± 4.528.5 ± 3.429.2 ± 4.029.2 ± 4.0 30.6 ± 4.130.8 ± 4.6O2 pulse (ml/beat)13.6 ± 3.013.3 ± 2.6 12.4 ± 2.212.9 ± 2.3 11.9 ± 2.711.9 ± 2.5OUES2.17 ± 0.502.09 ± 0.42 2.01 ± 0.392.11 ± 0.551.85 ± 0.331.87 ± 0.34Muscle strengthHand grip (kg)35.0 ± 6.834.2 ± 5.3 33.9 ± 6.536.3 ± 6.135.0 ± 6.734.1 ± 5.7CV event riskQRISK2(%)27.7 ± 10.8 27.2 ± 10.825.8 ± 9.826.0 ± 7.626.2 ± 7.227.4 ± 7.7CPET = cardiopulmonary exercise test; CV = cardiovascular; FACIT-Fatigue = Functional Assessment of Chronic Illness Therapy-Fatigue; FACT-P = Functional Assessment of Cancer Therapy-Prostate; FFM – fat-free mass; GodinQ = Godin Leisure-Time Exercise Questionnaire; HDL-C = high-density lipoprotein cholesterol; LDL-C = low-density lipoprotein cholesterol; OUES = oxygen uptake efficiency slope; PROs = patient reported outcomes; PSA = prostate specific antigen; SHGB = sex hormone binding globulin; VT = ventilatory threshold; VCO2 = carbon dioxide output; V?E = minute ventilation; VO2 = oxygen uptake; V?O2peak = peak oxygen uptake. Data are presented as mean ± SD or median [IQR]Table 3. Adjusted mean differences in outcomes at 3-months and 6-months3-months6-monthsAdjusted mean difference (95% CI)pAdjusted mean difference (95% CI)pBody compositionFat mass (kg)-1.9 (-4.9, 0.93)0.18-2.2 (-5.5, 1.1)0.18FFM (kg)1.2 (-1.2, 3.7)0.321.4 (-2.9, 5.8)0.51Body mass (kg)-0.98 (-2.7, 0.70)0.25-2.0 (-4.1, 0.08)0.061Waist circumference (cm)-0.32 (-3.0, 2.4)0.82-2.1 (-5.4, 1.3)0.22Waist to hip ratio-0.01 (-0.04, 0.02)0.480.00 (-0.04, 0.03)0.80Blood biomarkersPSA (ng/mL)-0.74 (-27.7, 26.2)0.96-3.1 (29.8, 23.6)0.82Total cholesterol (mmol/L)0.09 (-0.25, 0.42)0.610.12 (-0.22, 0.45)0.49HDL-C (mmol/L)0.07 (-0.04, 0.19)0.210.01 (-0.11, 0.13)0.81LDL-C (mmol/L)-0.02 (-3.0, 0.25)0.870.02 (-0.43, 0.46)0.94Triglycerides (mmol/L)-0.04 (-0.28, 0.21)0.770.09 (-0.15, 0.32)0.46Testosterone (nmol/L)0.14 (-0.12, 0.41)0.280.14 (-0.02, 0.29)0.084SHBG (nmol/L)1.6 (-6.2, 9.4)0.689.8 (-3.0, 22.6)0.13Insulin (pmol/L)10.8 (-7.4, 29.1)0.24-14.8 (-39.7, 10.1)0.23Glucose (mmol/L)0.27 (-0.11, 0.65)0.160.28 (-0.13, 0.68)0.18PROsFACT-P4.1 (-4.5, 12.6)0.348.5 (0.67, 16.3)0.034FACIT-Fatigue4.5 (0.62, 8.4)0.0244.2 (-1.3, 9.7)0.13GodinQ9.1 (-2.7, 20.9)0.1210.2 (0.74, 19.7)0.035CPET variablesV?O2peak (ml.kg-1.min-1)1.9 (0.16, 3.7)0.0340.95 (-1.0, 3.0)0.34VT (ml.kg-1.min-1)1.6 (0.38, 2.9)0.0120.73 (-0.32, 1.8)0.17V?E/VCO2-2.1 (-4.2, 0.02)0.052-1.8 (-4.0, 0.46)0.11V?E/VO2-1.3 (-3.4, 0.71)0.19-0.63 (-2.8, 1.5)0.56O2 pulse (ml/beat)0.98 (-0.25, 2.2)0.120.13 (-1.0, 1.3)0.81OUES0.21 (0.07, 0.35)0.0050.11 (-0.07, 0.29)0.23StrengthHand grip (kg)0.46 (-1.5, 2.5)0.651.0 (-0.67, 2.7)0.23CV event riskQRISK2 (%)-0.46 (-2.8, 1.9)0.68-2.9 (-5.8, 0.13)0.04195% CI = confidence interval; CPET = cardiopulmonary exercise test; CV = cardiovascular; FACIT-Fatigue = Functional Assessment of Chronic Illness Therapy-Fatigue; FACT-P = Functional Assessment of Cancer Therapy-Prostate; FFM – fat-free mass; GodinQ = Godin Leisure-Time Exercise Questionnaire; HDL-C = high-density lipoprotein cholesterol; LDL-C = low-density lipoprotein cholesterol; OUES = oxygen uptake efficiency slope; p = p-value; PROs = patient reported outcomes; PSA = prostate specific antigen; SHGB = sex hormone binding globulin; VT = ventilatory threshold; VCO2 = carbon dioxide output; V?E = minute ventilation; VO2 = oxygen uptake; V?O2peak = peak oxygen uptake.-34480566675Assessed for eligibility (n = 186)Excluded (n = 136)?? Not meeting inclusion criteria (n = 39)?? Declined to participate (n = 97)Completed assessment (n = 22)Withdrew from study (n = 2)??Lack of motivation (n = 2)Allocated to exercise group (n = 24)??Received allocated intervention (n = 24)Withdrew from study (n = 2)??Lack of interest (n = 2)Missed assessment (n = 4)??Conflicting schedules (n = 4)Allocated to control group (n = 26)??Received allocated intervention (n = 26)Completed assessment (n =20)3-monthsRandomised (n = 50)Completed assessment (n = 18)Completed assessment (n =19)Analysed by intention to treat (n = 24) ??Missing baseline data for grip strength (n = 1), PSA (n = 1), fat mass (n = 1), SHBG (n = 2), insulin (n = 2), and FFM (n = 1).Analysed by intention to treat (n = 26) ??Missing baseline data for testosterone (n = 1), VT (n = 1), grip strength (n = 2), fat mass (n = 2), SHGB (n = 2), insulin (n = 1), FFM = (n = 2), and FACT-P (n = 1).Allocation6-monthsAnalysis00Assessed for eligibility (n = 186)Excluded (n = 136)?? Not meeting inclusion criteria (n = 39)?? Declined to participate (n = 97)Completed assessment (n = 22)Withdrew from study (n = 2)??Lack of motivation (n = 2)Allocated to exercise group (n = 24)??Received allocated intervention (n = 24)Withdrew from study (n = 2)??Lack of interest (n = 2)Missed assessment (n = 4)??Conflicting schedules (n = 4)Allocated to control group (n = 26)??Received allocated intervention (n = 26)Completed assessment (n =20)3-monthsRandomised (n = 50)Completed assessment (n = 18)Completed assessment (n =19)Analysed by intention to treat (n = 24) ??Missing baseline data for grip strength (n = 1), PSA (n = 1), fat mass (n = 1), SHBG (n = 2), insulin (n = 2), and FFM (n = 1).Analysed by intention to treat (n = 26) ??Missing baseline data for testosterone (n = 1), VT (n = 1), grip strength (n = 2), fat mass (n = 2), SHGB (n = 2), insulin (n = 1), FFM = (n = 2), and FACT-P (n = 1).Allocation6-monthsAnalysis-1143000610235000 ................
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