Rajiv Gandhi University of Health Sciences, Karnataka,



|6 |Brief resume of the intended work: |

| | |

| | |

| | |

| | |

| | |

| | |

| |6.1 Need for the study |

| |Peripheral arterial disease (PAD) also known as peripheral arterial occlusive disease (PAOD) is defined as |

| |obstructive arterial disease of the lower extremities that reduces arterial flow during exercise or, in advanced |

| |stages, at rest. The presentation of PAD is varied and may appear as asymptomatic arterial disease with abnormal |

| |non-invasive test results, symptomatic disease presenting as classic or atypical intermittent claudication (IC), or |

| |critical limb ischemia (CLI). More than 50% of patients with PAD are asymptomatic or have atypical symptoms, one |

| |third has classic symptoms of IC, and 10% of patients develop CLI.1-2 |

| |A new analysis published by the SAGE group concluded that the atherosclerotic PAD afflicts over 20 million in India. |

| |Mary Yost, author of the report stated that although PAD was believed to be a ‘western’ disease with lower prevalence|

| |in Asian Indians, their research had indicated the otherwise. The author stated that PAD appeared to afflict Indians |

| |at similar rates as those found in European and US.3 |

| |The report predicted the risk of developing PAD as tobacco use, hypertension, dyslipidaemia and diabetes in the |

| |Indian population3 .The risk of developing PAD can also be predicted by age, gender, race and well-defined |

| |atherosclerotic risk factors, including hypercholesterolemia, serum cholesterol level, coronary heart disease, |

| |hyperhomocysteinemia and chronic renal insufficiency.4 |

| |Smoking is by far the single most important risk factor for peripheral arterial disease (PAD).5 The relationship |

| |between smoking and PAD has been recognized since 1911, when Erb reported that IC was three-times more common in |

| |smokers and six-times more common in heavy smokers compared with non-smokers. It has been suggested that the |

| |association between smoking and PAD may be even stronger than that between smoking and coronary artery disease (CAD).|

| |Furthermore, a diagnosis of PAD is made approximately a decade earlier in smokers than in non-smokers. The severity |

| |of PAD tends to increase with the number of cigarettes smoked4. |

| |The amount and duration of tobacco use correlate directly with the development and progression of PAD.6 Smoking |

| |increased the risk of intermittent claudication by a factor of eight to 10 in the Reykjavik study, and cessation of |

| |tobacco use resulted in a 50% reduction in rates of intermittent claudication over a 20-year period among Icelandic |

| |men. The study assessed the relationship between smoking dose response and PAD found a statistically significant |

| |exposure associated with an increase in PAD incidence.7 |

| |Heavy chronic smokers have a four-fold higher risk of developing IC compared with non-smokers. A cause-and- effect |

| |relationship between the use of tobacco products and the development of PAD is best demonstrated by those patients |

| |who successfully discontinue tobacco use and have no further progression or regression of their PAD.8 In a study done|

| |by Jonason et al9, the rates of development of rest pain in patients with intermittent claudication were zero in |

| |non-smokers and 16% in smokers.10 Among current smokers 32% of peripheral arterial disease was attributable to |

| |current smoking and an additional 40% was attributable to past smoking among male former smokers, a study conducted |

| |by Fowler B. et al.11 |

| |In most instances the diagnosis of PAD is clear from the clinical history. The presence of IC results in a severe |

| |limitation in exercise performance and walking ability. The exercise limitation is associated with marked impairment |

| |in walking distance, walking speed and overall function.4 Treadmill testing is the main assessment method to|

| |evaluate walking ability in patients with PAD in clinical studies and currently the most commonly used as expressed |

| |in meters.12 Walking ability, as assessed by a treadmill test, is usually the primary endpoint in clinical trials of |

| |treatments for patients with PAD. A measured parameter at the exercise test is the total walking distance. In |

| |clinical trials, the primary endpoint is usually a treadmill test of the peak walking time or distance as well as the|

| |time or distance for the onset of claudication13. |

| |Initial claudication distance (ICD) or claudication-free distance is the distance that a claudicant can walk on the |

| |treadmill without pain in the limb(s) or the distance walked at the onset of claudication pain. Absolute claudication|

| |distance (ACD) or maximal walking distance is the maximal distance that a claudicant can walk on a treadmill or the |

| |distance at which claudication pain becomes so severe that the patient is forced to stop.14-15 |

| |However, the definition of both ICD and ACD is not correspondent with distances a patient would walk in daily life. |

| |Although most patients will continue to walk after appearance of the first signs of pain, few will walk until their |

| |maximum pain threshold is reached during the course of daily activities. For this reason, the distance at which a |

| |patient prefers to stop because of claudication pain is a better instrument by which to measure the functional |

| |impairment of patients with intermittent claudication. According to Kruidenier et al15 Functional Claudication |

| |Distance (FCD) is defined as the distance at which a patient prefers to stop because of claudication pain. |

| |The study concluded that the functional claudication distance was a reliable measurement for determining functional |

| |capacity in trained patients with intermittent claudication. The study signified that FCD correlated with physical |

| |function, physical role, vitality, pain and health change domain of RAND-36 Questionnaire16. FCD correlated five out |

| |of nine domains compared to two and three domain for ICD and ACD respectively in correspond to general quality of |

| |life thus making it a valid assessment tool for which the author suggested FCD could be used in conjunction with ICD |

| |and ACD15. |

| |In addition to it, the study included patients familiar with treadmill walking which could have influenced the |

| |reliability results. Furthermore, including patients with unfamiliar treadmill walking could establish a baseline |

| |reliability to assess the patient population. Since many researches have established smoking as a causative factor |

| |for PAD and around 50 % of PAD patients are asymptomatic, there is a need for assessing the functional limitation in |

| |smokers. Consequently FCD better reflected the actual functional impairment in the study by Kruidenier et al; |

| |therefore establishing it as an effective tool in assessing functional limitation in patient with IC, it may as well |

| |assess the functional limitation in smokers. |

| | |

| |Reaserch question: |

| |Is FCD a reliable and an effective tool to determine the functional limitation in smokers? |

| | |

| |6.2 Review of literature: |

| |Lotte M Kruidenier, Saskia PA Nicolaï, Edith M Willigendael, Rob A de Bie, Martin H Prins and Joep AW Teijink (2009) |

| |conducted a study to test the reliability and validity measurement of functional claudication distance in patient |

| |with intermittent claudication. The subjects followed a supervised exercise therapy program consisted of two |

| |standardized treadmill test to estimate the reliability and a standardized treadmill testing and filled out the |

| |rand-36 questionnaire to assess the validity. The study confirmed the FCD as reliable and valid measurement for |

| |determining functional capacity in subjects with intermittent claudication. The author concluded FCD better reflects |

| |the actual functional impairment and suggested FCD could be used alongside ICD and ACD.15 |

| |Saskia P.A. Nicolaï, Wolfgang Viechtbauer, Lotte M. Kruidenier, Math J.J.M. Candel, Martin H. Prins, Joep A.W. |

| |Teijink. (2009) conducted a meta-regression analysis to identify the most reliable treadmill protocol for the |

| |assessment of patients with peripheral arterial disease (PAD). The authors identified the criteria in trials |

| |assessing reliability of treadmill testing of which used a C- or G-protocol, repetition of this protocol, and a |

| |retrievable intraclass correlation coefficient (ICC). The authors identified eight studies in which 658 patients were|

| |included and concluded that treadmill assessment has the highest reliability when using a G-protocol together with |

| |the ACD as the primary outcome measure.12 |

| |Bendermacher BL, Willigendael EM, Nicolaï SP, Kruidenier LM, Welten RJ, Hendriks E, Prins MH, Teijink JA, de Bie RA |

| |(2007) conducted a cohort study to determine the effect on walking distances of supervised exercise therapy provided |

| |in a community-based setting. The study included all consecutive patients presenting at the vascular outpatient |

| |clinic with intermittent claudication, The intervention was a supervised exercise therapy in a community-based |

| |setting; a progressive treadmill test at baseline and at 1, 3, and 6 months of follow-up measured initial |

| |claudication distance and absolute claudication distance. The study concluded that the supervised exercise therapy in|

| |a community-based setting is a promising approach to providing conservative treatment for patients with intermittent |

| |claudication.19 |

| |Adriana Planas, Alberto Clará, Jaume Marrugat, José-María Pou, Anna Gasol, Anna de Moner, Carmen Contreras, Francesc |

| |Vidal-Barraquer (2002) conducted a study to analyze the relationship between age at smoking onset and development of |

| |symptomatic peripheral arterial occlusive disease (PAOD). Population-based samples of 573 active or former male |

| |smokers aged 55 to 74 years were studied. The study concluded that a starting age for smoking of 16 years or earlier |

| |more than doubles the risk of future symptomatic PAOD regardless of the amount of exposure to cigarette smoking.20 |

| | |

| |S. Degischer, KH Labs, M. Aschwanden, M. Tschoepl, K. A. Jaeger (2002) conducted a study to evaluate the reliability |

| |of constant-load testing with various workloads and compared them with claudication distances achieved with walking |

| |at normal speed on level ground and also evaluated whether metabolic equivalent (MET) normalization can be used to |

| |translate the results of different treadmill tests into each other. Fifteen patients with claudication underwent |

| |repeated treadmill testing with different treadmill settings. The walking capacity was also tested on level ground |

| |with a speed chosen by the individual patient. The relationship between real and predicted claudication distances was|

| |tested with regression modelling. The study concluded that for optimal treadmill test reliability, higher workloads |

| |should be used and ACD should be preferred over initial claudication distance. MET normalization provides the basis |

| |for the comparability of treadmill test results achieved with different test conditions.22 |

| |M. Cachovan, W. Rogatti, A. Creutzig, C. Diehm, H. Heidrich, P. Scheffler and F. Woltering (1997) conducted a study |

| |to compare the correlation and practicability of single-stage vs. graded treadmill protocols in the assessment of the|

| |absolute claudication distance (ACD). The authors had taken 52 patients with peripheral arterial occlusive disease; |

| |the ACD on treadmill at constant-load test (C-test) and the graded-exercise test (G-test) were carried out at random |

| |on the same day under standardized conditions. The study concluded that the assessment of the ACD in patients with |

| |severe claudication the C-test would seem to be more suitable than the G-test.23 |

| |Ingolfsson IO, Sigurdsson G, Sigvaldason H, Thorgeirsson G, Sigfusson N. (1994) conducted the study on Peripheral |

| |vascular disease, which gave an opportunity to monitor secular trends from 1968 to 1986 of clinical intermittent |

| |claudication (IC) amongst Icelandic males and to assess the importance of possible risk factors. The study concluded |

| |that both the prevalence and incidence of IC decline occurred a few years earlier than the decline of Chronic Heart |

| |Disease in Iceland. The study indicated the only significant risk factors for intermittent claudication, in addition |

| |to age, was smoking which increased the risk of IC 8 to 10 fold.7 |

| |Freund Km, Belanger Aj, D’agostino Rb, et al. (1993) conducted the study to determine the effects of both the rate |

| |and the cumulative dose of cigarette smoking on the health. Out of 5209 individuals aged 30 to 62 years at entry, it |

| |was observed that cigarette smoking was the prime determinant of chronic cough, and reduced both forced vital |

| |capacity and the 1-second forced expiratory volume, after a 34 year follow-up. The study signified the relationship |

| |between cigarette smoking and the incidence of cancer of the lung, stroke and transient ischemic attacks, |

| |intermittent claudication, and total cardiovascular disease, and most especially the average annual death rate. The |

| |study data confirmed and extended the evidence of the detrimental influence of cigarette smoking on health.6 |

| |Jonason T, Bergstrom R. (1987) conducted the study about the effects of cessation of smoking in 343 patients with |

| |intermittent claudication. The outcome in two groups was compared based on baseline characteristics. The study shows |

| |that Rest pain did not develop in any of the non-smokers and in smokers the cumulative proportion with rest pain was |

| |16% after seven years (p less than 0.05). The cumulative proportions with the 10-year survival 82 and 46% among |

| |non-smokers and smokers. The study provided the evidence that it is of utmost importance the patients with |

| |intermittent claudication stop smoking.9 |

| |Quick Cr, Cotton Lt. (1982) conducted a 10 month study of 124 limbs in patients suffering from intermittent |

| |claudication. Changes in ankle pressure and treadmill exercise tolerance over the period were compared between two |

| |groups, one of patients who continued to smoke (group 1) and the other of those who gave up (group 2). The study |

| |concluded that Ankle pressures after exercise and maximum treadmill walking distance did not change in smokers but |

| |significantly improved in past smokers. Also the authors concluded that stopping cigarette smoking increased the |

| |chance of improvement in ankle pressure and exercise tolerance in intermittent claudication.8 |

| | |

| |6.3 Objective of the study |

| |The aim of the study is to investigate the reliability of FCD along with ICD and ACD to assess the functional |

| |limitation among the population who are smokers. |

|7 | |

| |Materials and Methods |

| |Source of data: smoking de-addiction center in and around Bangalore |

| | |

| |Method of collection of data: |

| |Population :- Subjects who are smokers |

| |Sample Design :- Purposive sampling |

| |Sample size :- 60 |

| |Type of study :- population reliability |

| |Duration of study :- 6 months |

| |Inclusion Criteria |

| |Current smokers with a history of smoking of at least 5 years. |

| |Age: 25 to 55 years |

| |Cigarette smoked per day: 5 to 20 cigarette/day |

| |Male subjects |

| |Exclusion criteria |

| |Pre-existing medical condition |

| |Subjects trained on treadmill |

| |History of diabetes mellitus |

| |Pre-existing vascular disease |

| |Severe mental disorder |

| |Terminal illness |

| |Dyslipidemia |

| |Subjects unwilling to do study |

| | |

| |Material used: Treadmill without hand-rail |

| |Measuring tools: Walking distance measured in meters |

| | |

| |Methodology |

| |Intervention to be conducted on the participants: |

| |After getting ethical clearance subjects will be enrolled in the study. Subjects will be enrolled based on the |

| |inclusion and exclusion criteria. Thirty subjects will be interviewed with the question such as current smoking |

| |status, no of cigarette smoked and pack year is calculated accordingly. None of the subjects will receive vasoactive |

| |or non-steroidal anti-inflammatory drugs in the week before the study, and all abstained from alcohol for 24 hours |

| |before and from food, tobacco, and caffeine-containing drinks on the day of the study. All studies will be performed |

| |in a quiet, temperature controlled room maintained at 23.5°C to 24.5°C.18 |

| |In the study the subjects will perform two standardized treadmill tests within the gap of 24 hours. A progressive |

| |treadmill test will be used according to Gardner et al19 with a constant speed of 3.2 km/h and an increase in |

| |inclination of 2% every two minutes, beginning with 0% inclination. The inclination and testing duration will be |

| |maximized to 10% and 30 minutes (1600 meters), respectively. During treadmill testing all the subjects will be |

| |supervised. At each test all walking distances (ICD, FCD, and ACD) will be measured. Patients indicated the onset of |

| |claudication pain, the point of preferring to stop, and the point that maximum walking distance is reached. The |

| |subjects will be rested for 10 minutes before each test to ensure that no claudication pain is present at the start. |

| |Handrail support will not be allowed. In case of unbalance, the researcher will give the subjects his hand to hold on|

| |to until balance is regained. During the treadmill tests, the subjects will be blinded for the distance/time walked |

| |by covering the display of the treadmill.The study will be done to compare reliability of FCD with both ICD and ACD |

| |to determine the value of FCD for testing functional impairment in smokers18. |

| |Outcome measures: |

| |Treadmill walking distance: Intermittent Claudication Distance (ICD), Functional Claudication Distance (FCD), |

| |Absolute Claudication Distance (ACD) |

| |Statistics: |

| |Statistical analysis will be performed by using SPSS software (version 17) compatible with Windows. Alpha value will |

| |be set at .05 |

| |Descriptive statistics will be used to assess demographic variables and variables of the walking distance of |

| |treadmill test. |

| |The intraclass correlation will be used to assess the intrarater reliability. |

| |Microsoft word and excel will be used to generate tables and graphs. |

| |7.3 Does the study require any investigation or interventions to be conducted on patients or other humans or animals?|

| |If so, please describe briefly. |

| |Yes, the study will be carried out on human male subjects with the age group of 25 to 55 years who are smokers to |

| |determine the reliability of FCD to assess the functional limitation. |

| |7.4 Has ethical clearance been obtained from your institution in case of 7.3? |

| |Yes, the ethical clearance has been obtained from the institution. As this study involve human subjects, the ethical |

| |clearance has been obtained from the Ethical Committee of Padmashree Institute of Physiotherapy, Nagarbhavi, |

| |Bangalore, as per ethical guidelines research from biomedical research on human subjects, 2000, ICMR, New Delhi. |

|8 |List of References |

| |Hiatt wr. Medical treatment of peripheral arterial disease and claudication. N engl j med 2001; 344:1608– 1621 |

| |Athanasios Stoyioglou, Michael R. Jaff. Medical treatment of peripheral arterial disease: A comprehensive study. J |

| |Vasc Interv Radiol 2004; 15:1197–1207 |

| |The SAGE group. Report on the epidemiology of PAD, TAO and CLI in India. Published on November 13, 2009. |

| |Inter-society consensus for the management of peripheral arterial disease (TASC ii). Norgren, W.R. Hiatt, J.A. |

| |Dormandy, M.R. Nehler, K.A. Harris and F.G.R. Fowkes on behalf of the TASC ii working group. 2007 |

| |Simon D. Hobbs, Antonius B. M. Wilmink, Donald J. Adam, Andrew W. Bradbury. Assessment of smoking status in patients |

| |with peripheral arterial disease. J Vasc Surg 2005; 41:451-6. |

| |Freund Km, Belanger AJ, D’agostino Rb, et al. The health risks of smoking: the Framingham study: 34 years of follow- |

| |up. Ann epidemiol 1993; 3:417– 424 |

| |Ingolfsson IO, Sigurdsson G, Sigvaldason H, Thorgeirsson G, Sigfusson N. marked decline in the prevalence and |

| |incidence of intermittent claudication in Icelandic men 1968–1986: a strong relationship to smoking and serum |

| |cholesterol—the Reykjavik study. J clin epidemiol 1994; 47:1237–1243 |

| |Quick Cr, Cotton Lt. The measured effect of stopping smoking on intermittent claudication. Br j surg 1982; 69(suppl):|

| |s24 –s26. |

| |Jonason T, Bergstrom R. Cessation of smoking in patients with intermittent claudication: effects on the risk of |

| |peripheral vascular complications, myocardial infarction and mortality. Acta med scand 1987; 221:253–260 |

| |Ameli Fm, Stein M, Provan Jl, Prosser R. The effect of postoperative smoking on femoropopliteal bypass grafts. Ann |

| |vasc surg 1999; 3:20 –25. |

| |Fowler B, Jamrozik K, Norman P, Allen Y. Prevalence of peripheral arterial disease: persistence of excess risk in |

| |former smokers. Aust N Z J public health 2002;26:219-24 |

| |Saskia P.A. Nicolaï, Wolfgang Viechtbauer, Lotte M. Kruidenier, Math J.J.M. Candel, Martin H. Prins, Joep A.W. |

| |Teijink. Reliability of treadmill testing in peripheral arterial disease: A meta-regression analysis. J Vasc Surg |

| |2009;50:322-9 |

| |Labs KH, Dormandy Ja, Jaeger Ka, Stuerzebecher C, Hiatt Wr. Trans-Atlantic conference on clinical trial guidelines |

| |in PAOD (peripheral arterial occlusive disease) clinical trial methodology. Eur j vasc endovasc surg |

| |1999;18(3):253e265 |

| |European heart journal (1999) 20, 641–644. Estimation of walking distance in intermittent claudication: need for |

| |standardization. Article no. Euhj.1998.1394 |

| |Kruidenier Lm, Nicolai Sp, Willigendael Em, De Bie Ra, Prins Mh, Teijink Ja. Functional claudication distance: a |

| |reliable and valid measurement to assess functional limitation in patients with intermittent claudication. BMC |

| |cardiovasc disorder. 2009; 9(1):9. |

| |Zee KI van der, Sanderman R: [Measuring general health with the RAND-36: a manual]. Groningen 1993 |

| |Newby De, Wright Ra, Labinjoh C, et al. Endothelial dysfunction, impaired endogenous fibrinolysis, and cigarette |

| |smoking: a mechanism for arterial thrombosis and myocardial infarction. Circulation 1999; 99:1411–1415 |

| |Gardner AW, Skinner JS, Cantwell BW, and Smith LK: Progressive vs. single-stage treadmill tests for evaluation of |

| |claudication. Medicine and science in sports and exercise 1991, 23(4):402-408. |

| |Edith M. Willigendael, Joep A. W. Teijink, Marie-Louise Bartelink, Barthold W. Kuiken, Jelis Boiten, Frans L. Moll, |

| |Harry R. Büller, and Martin H. Prins.Influence of smoking on incidence and prevalence of peripheral arterial disease.|

| |J Vasc Surg 2004; 40:1158-65. |

| |Bendermacher BL, Willigendael EM, Nicolai SP, Kruidenier LM, Welten RJ, Hendriks E, Prins MH, Teijink JA, de Bie RA: |

| |Supervised exercise therapy for intermittent claudication in a community- based setting is as effective as |

| |clinic-based. J Vasc Surg 2007, 45(6):1192-1196. |

| |Adriana Planas, Alberto Clará, Jaume Marrugat, José-María Pou, Anna Gasol, Anna de Moner, Carmen Contreras, Francesc |

| |Vidal-Barraquer, Age at onset of smoking is an independent risk factor in peripheral artery disease development. J |

| |Vasc Surg 2002; 35:506-9 |

| |S. Degischer, KH Labs, M. Aschwanden, M. Tschoepl, K. A. Jaeger. Reproducibility of constant-load treadmill testing |

| |with various treadmill protocols and predictability of treadmill test results in patients with intermittent |

| |claudication. J Vasc Surg 2002; 36: 83-8. |

| |M. Cachovan, W. Rogatti, A. Creutzig, C. Diehm, H. Heidrich, P. Scheffler and F. Woltering .Treadmill Testing for |

| |Evaluation of Claudication: Comparison of Constant-load and Graded-exercise Tests. Eur J Vasc Endovasc Surg 14, |

| |238-243 (1997) |

| | |

| | |

| | |

| | |

| | |

| | |

| | |

| | |

| | |

| | |

| | |

| | |

| | |

| | |

| | |

................
................

In order to avoid copyright disputes, this page is only a partial summary.

Google Online Preview   Download