Rajiv Gandhi University of Health Sciences Karnataka



RAJIV GANDHI UNIVERSITY OF HEALTH SCIENCES,

BANGALORE, KARNATAKA.

ANNEXURE-II

PROFORMA FOR REGISTRATION OF SUBJECTS FOR DISSERTATION

| 1. |NAME AND ADDRESS OF THE CANDIDATE |MULAY SNEHA SHRIKRISHNA |

| | |K.T.G. Girls Hostel, |

| | |Hegganahalli Cross, Vishwaneedam Post, |

| | |Sunkadakatte Via Magadi Road, |

| | |Bangalore- 560091 |

|2. |NAME AND ADDRESS OF THE INSTITUTION |K.T.G COLLEGE OF PHYSIOTHERAPY, |

| | |Hegganahalli Cross, Vishwaneedam Post, |

| | |Sunkadakatte Via Magadi Road, |

| | |Bangalore -560091 |

|3. |COURSE OF STUDY AND SUBJECT |MASTER OF PHYSIOTHERAPY |

| | |(Community Based Rehabilitation) |

|4. |DATE OF ADMISSION TO COURSE |01-04-2013 |

|5. |TITLE OF THE TOPIC |

| |“EFFECTIVENESS OF FLEXIBILITY EXERCISES ON BALANCE, FUNCTIONAL MOBILITY, AND DISABILITY FOR SEDENTARY COMMUNITY ELDERLY” |

| 6. | Brief resume of the intended work: |

| |Need for the study |

| |Spontaneous activity levels decline with aging in most individuals, resulting in increased sedentariness and its attendant adverse effects.1 Fried and|

| |Guralnik2 characterized physical disability as a major adverse health outcome of aging and underscored the fact that 84% of people 65 years and older |

| |are dependent on others in activities of daily living or instrumental activities of daily living in the community. |

| |Living a sedentary life into older age can lead to a loss of functional health due to deficits in strength, endurance, and flexibility that are |

| |consistently related to inactivity.1 Flexibility Flexibility or limberness refers to the range of movement in a joint or of joints, and length in |

| |muscles that cross the joints. Flexibility varies between, particularly in of differences in muscle length of multi-joint muscles. Flexibility in some|

| |joints can be increased to a certain degree by exercise, with stretching a common exercise component to maintain or improve flexibility.1-4 |

| |Deconditioning is a complex process of physiological change following a period of inactivity, bedrest or sedentary lifestyle. It results in functional|

| |losses in such areas as mental status, degree of continence and ability to accomplish activities of daily living.3 |

| |Restricted activity, defined as staying in bed for at least half a day and/or cutting down on one’s usual activities because of an illness, injury, or|

| |other problem, is common among community living older persons, regardless of risk for two days of bedrest.4 The most predictable effects of |

| |deconditioning are seen in the musculoskeletal system and include sarcopenia or diminished muscle mass, decreases of muscle strength by two to five |

| |per cent per day, muscle shortening, changes in periarticular and cartilaginous joint structure and marked loss of leg strength that seriously limit |

| |mobility. The decline in muscle mass and strength has been linked to falls, functional decline, increased frailty and immobility. Many elderly who are|

| |living independently at home are at the threshold of strength required to perform the activities of daily living essential to their independence.5 As |

| |part of the normal aging process they experience a decrease in muscle strength and a decline in activity, leading to weight gain. These changes, |

| |combined with other factors such as deteriorating vision, balance and coordination, result in greater risk for falls.6 In geriatric it has been found |

| |that decline in get up and go time, balance and functional activities due to deconditioning changes. |

| |Findings show that, among community-dwelling older people over 64 years of age, 28-35% fall each year. Of those who are 70 years and older, |

| |approximately 32%-42% fall each year. The frequency of falls increases with age and frailty level.7 |

| |Various health problems in the elderly are not necessarily a consequence of ageing. Poor health and early mortality can be attributed to physical |

| |inactivity and lack of sufficient and appropriate physical activity or exercise interventions.8 |

| |Functional dependence in geriatric institutions raises important issues related to decline in overall health related quality of life (HRQoL) and |

| |professional caregivers’ distress. Physical inactivity and disability in elderly patients may negatively affect their ability to perform activities of|

| |daily living (ADL) and worsen their HRQoL status.9-12 |

| |Many studies show that impaired balance and decreased lower extremity strength are important risk factors in the loss of physical functioning and |

| |occurrence of falls in older adults.13 Exercise can improve body composition, diminish falls, increase strength, reduce depression, reduce arthritis |

| |and pain, reduce risks for diabetes and coronary artery disease, and improve longevity.1 Research has consistently shown that older adults who remain |

| |or become active have a significantly decreased risk of all-cause and cardiovascular mortality compared with their sedentary counterparts.14 Previous |

| |research has shown that exercises such as strength and flexibility training, balance training,15 tai chi,13 and combinations of these activities |

| |delivered in a class situation or individually16 have increased strength and improved balance and functional activity in addition to reducing the |

| |risk of falls. In the course of typical aging, connective tissue loses its elasticity and range of movement. |

| |There were studies has been done on effect of exercise program in elderly persons but there was no study found on effect of stretching exercises in |

| |sedentary elderly. Hence the purpose of this study is to investigate effect of flexibility exercises on balance, functional mobility and disability |

| |for sedentary community geriatrics. |

| |Research Question: |

| |Whether the flexibility exercises does have an effect on balance, functional mobility and disability for sedentary community geriatrics? |

| | |

| | |

| | |

| |Hypothesis : |

| |Null hypothesis: |

| |There will be no significant effect of flexibility exercise on balance, functional mobility and |

| |disability for sedentary community geriatrics. |

| |Alternate hypothesis: |

| |There will be significant effect of flexibility exercise on balance, functional mobility and |

| |disability for sedentary community geriatrics. |

| | |

| |Review of Literature: |

| |Bert H Jacobson et al.(2011) studied the effectiveness of independent static balance training contributing to increased stability and functional |

| |capacity in community dwelling elderly people a randomized controlled trial and concluded that Standing, static balance exercises conducted |

| |independently without safety supervision led to improvements in balance, functional ability, and leg functioning in frail elderly people.17 |

| |Arnaud Dechamps, PhD et al. (2010) conducted a study to know the effects of exercise programs to prevent decline in health-related quality of life in |

| |highly deconditioned institutionalized elderly persons a randomized controlled trial and concluded that adapted exercise programs can slow down the |

| |decline in health-related quality of life among heterogeneous, institutionalized elderly persons.18 |

| | |

| |Esma Ceceli et.al (2009) compared the balance, functional activity, and flexibility of elderly people performing flexibility exercises regularly with |

| |sedentary elderly people. They concluded that that ROM exercises, when performed regularly, have beneficial effects mainly on functional ability and |

| |flexibility and some effects on balance.19 |

| |Yung-Hui Tien, Kuei-Fu Lin (2008) studied on the relationships between physical activity and static balance in elderly people. In their study they |

| |concluded that risk factors associated with balance in elderly people, includes coordination deficit, musculoskeletal weakness, gait abnormalities, |

| |neuromuscular system impairment, and sensitivity for spatial orientation deficit. These factors could limit balance ability.20 |

| |Tatjana Bulat et al. (2007) In their study they determined the effectiveness of eight week group functional balance training classes on balance |

| |outcomes in community-dwelling elderly people at risk for falls. They found that an eight week group functional balance training class was safe and |

| |effective in improving balance outcomes in a cohort of elderly people at risk for falls.21 |

| |Catherine M Arnold and Robert A Faulkner (2007) Studied on history of falls and the association of the timed up and go test to falls and near-falls in|

| |older adults with hip osteoarthritis. In their study they concluded that a high percentage of older adults with hip ostoarthritis experience falls and|

| |near-falls which may be attributed to gait impairments related to hip osteoarthritis.22 |

| |Tomoko Yamauchi et al. (2005) Studied the efficacy of a home-based well-rounded exercise program (WREP) in older adults. . General physical |

| |characteristics, functional strength (Arm Curl [AC], Chair Stand [CS]), dynamic balance and agility (Up & Go [UG]), flexibility (Back Scratch [BS], |

| |Sit & Reach [SR]), and endurance (12-min walk [12-MW]) were measured. Following the 12-wk home-based WREP, improvements were observed in AC, CS, UG, |

| |BS, SR and 12-MW for the exercise group but not for the control group. These results suggested that the home-based WREP can improve overall fitness in|

| |older adults.23 |

| |Solange Czerniewicz and Claire M Nicholson (2004) studied on the benefits of exercise in the elderly and concluded that they have reviewed the role of|

| |the Physiotherapist, Biokineticists and exercise scientist in the health and functional enhancement of the elderly and have emphasized that well |

| |trained professionals are needed to promote the value of exercise therapy as well as encourage regular participation and sufficient doses of physical |

| |activity.24 |

| |Susan L. Whitney Gregory F. Marchettid, Annika Schadee and Diane M. Wrisleya (2004) |

| |Studied to determine the sensitivity and specificity of the timed “up & go” (TUG) and the dynamic gait index(DGI) for self-reported falls in persons |

| |with vestibular disorders and concluded that sensitivity (80%) and specificity (56%) were calculated for TUG scores of greater than 11.1 seconds. The |

| |TUG and the DGI appear to be helpful in identifying fall risk in persons with vestibular dysfunction. Slower scores on the TUG (>11.1 seconds) and |

| |lower scores on the DGI (18) correlated with reports of falls in persons with vestibular dysfunction.25 |

| | |

| |Naomi Pollak , Wendy Rheault, Judith L. Stoecker (1996) studied to evaluate treatment outcome and plan realistic rehabilitation goals for elderly |

| |patients. The reliability, validity, and appropriateness of the Functional Independence Measure (FIM) were examined for a population aged 80 years and|

| |more from a multilevel, continuing care retirement community.  Construct validity of the FIM was demonstrated. High test-retest reliability was |

| |demonstrated. In their study they suggest that with certain caveats, the FIM may be useful as a functional assessment instrument for persons who are |

| |80 or more years old.26 |

| |Podsiadlo D, Richardson S (1991) made a study to know the timed "Up & Go" a test of basic functional mobility for frail elderly persons and concluded|

| |that the timed "Up & Go" test is a reliable and valid test for quantifying functional mobility that may also be useful in following clinical change |

| |over time. The test is quick, requires no special equipment or training, and is easily included as part of the routine medical examination.27 |

| |Objective of the study: |

| |To determine the effectiveness of flexibility exercises on balance, functional mobility and disability for sedentary community geriatrics |

|7. |Materials and Methods: |

| |7.1 Study Design |

| |An experimental study design with two groups the physically active control group (group A) and sedentary group (group B). |

| |7.2 Methodology |

| |Sample size |

| |The study will be carried out on 40 subjects. (Group A-20,Group B-20) |

| |Study population |

| |Community Geriatrics |

| |Source of data |

| |Day Care Centre for Geriatric at Bangalore. |

| |Community Day Care Centre at Bangalore. |

| |Community Geriatric at Bangalore. |

| |Florence health care home.(Nagarbhavi) |

| |Gandhi senior citizen home(Near Bangalore University) |

| |Maneyangala old age home (Malleshwaram). |

| |Nightingales elders enrichment centre (Malleshwaram). |

| |Various community based geriatric rehabilitation centers across Bangalore |

| | |

| |Sampling Method |

| |Convenience sampling. |

| |Study Duration |

| |The study will be undertaken for a total of 4 weeks. |

| |Sample Selection |

| |Inclusion Criteria for sedentary group: |

| |• Subjects with the age 60 years and older. |

| |Subjects had to have the ability to get up alone or with technical or human help if necessary. |

| |Subjects had to have the ability to understand basic motor commands. |

| |Subjects with the sedentary lifestyle or prolong bed rest. |

| |Sedentary lifestyle, and had not participated in regular exercises from past 5 years. |

| |Independent in their activities of daily living, with a Barthel Index of 10,9 |

| |Able to ambulate without an assistive device |

| | |

| |Exclusion Criteria |

| |Subjects with serious conditions like infections, CVA, tumors, osteoporosis and any fracture etc. |

| |Subjects with history of disability. |

| |Subjects with terminally ill and bedridden patients. |

| |Subjects with visual deficiency, severe auditive deficiency. |

| |Materials used: |

| |Paper |

| |Pen |

| |Arm chair |

| |Inch tape |

| |Stop watch |

| | |

| |7.3. Method of data collection |

| |Ethical Clearance and Consent for the study |

| |As the study includes human subjects ethical clearance is obtained from ethical committee of K.T.G. College of Physiotherapy. Subjects who fulfils the|

| |inclusion criteria, complete explanation will be given to subjects and once the subjects agrees to participate in the study, an informed written |

| |consent (Annexure-1) will be taken from the subjects. |

| |Intervention for Control Group – Instructed to perform their regular routine exercises and activities |

| |Intervention for Sedentary Group – Flexibility exercises. |

| |Pre measures will be taken before the study for both the groups using Berg Balance scale and Timed get up and go test. |

| | |

| |Procedure of Intervention in Control Group – Instructed to perform their regular routine exercises and activities and general instruction will be |

| |given to allocate the usual care. Subjects will be reviewed once in a week. |

| | |

| |Procedure of Intervention in Sedentary Group |

| |All the subjects in this group will perform ROM exercises for increasing flexibility under the supervision of a physiotherapist. Exercises will be |

| |held on a mat, with all the subjects lying in supine position, and 10 repetitions of motions for each upper- and lower-extremity joint will be |

| |performed within the range of joint movement, with stretching at the end. Stretching exercises, consisting of head rotation, shoulder rotation and |

| |stretching of the upper and lower limbs, Trunk muscles. The exercise sessions will be held in the morning. Each session lasted about 20 minutes, but |

| |the participants did not have to finish the session; they continued to the point of tiredness. The exercises will be done 3 times a week for 4 |

| |weeks.18 |

| |The patients will be instructed and encouraged to continue the same exercises at geriatric center at least three times a week for 20 min. A manual |

| |with instructions and illustrations for each exercise |

| |will be distributed. The frequency of participation in the geriatric home-based exercises will be noted during the session in a week by the |

| |physiotherapist. The exercise program will be continued for 4 weeks. |

| | |

| |Post measures after 4 weeks measurements will be taken after the study for both the groups using Berg Balance scale and Timed get up and go test, |

| |Functional Independence Measure Scale |

| |Outcome measures : |

| |Balance will be evaluated using Berg Balance test |

| |Functional mobility will be measured using Timed Get-up and Go test. |

| |Functional disability will be measured using Functional Independence Measure Scale. |

| |Statistics: |

| |Statistical analysis will be performed by using SPSS software (window version 16) and p-value will be set as 0.05. |

| |Descriptive statistics will be used to analyze the baseline data for demographic and outcome data using chi-square test. |

| |Paired ‘t’ test as a parametric and Wilcoxon signed rank test as a non-parametric test have been used to analysis the variables pre-intervention to |

| |post-intervention with calculation of percentage of change. |

| |Independent ‘t’ test as a parametric and Mann Whitney U test as a non-parametric test have been used to compare the means of variables between groups|

| |with calculation of percentage of difference between the means. |

| | |

| |7.4 Ethical Clearance:- |

| |As this study involve human subjects, the ethical clearance has been obtained from the research and ethical committee of institution, as per ethical|

| |guidelines research from biomedical research on human subjects, 2000, ICMR, New Delhi. |

|8. |List of References: |

| | |

| |Christmas C, Andersen RA. Exercise and older patients: guidelines for the clinician. J Am |

| |Geriatr Soc. 2000;48:318–324. |

| |Fried LP, Guralnik JM. Disability in older adults: evidence regarding significance, etiology, |

| |and risk. J Am Geriatr Soc. 1997;45:92–100. |

| |Brand, C, Campbeil, D., Jones, C, Russell, D., Andrew, L. a Tweddle, N, (2003). A randomised controlled trial of an exercise intervention to reduce |

| |functional decline and health service utilisation in the elderly. from CiinicaiEpidemology/ NewJiles/ProtocolFMP.pdf. |

| |Gill TM, Desai MM, Gahbauer EA, Holford TR, Williams CS. Restricted activity among community-living older persons: incidence, precipitants, and health|

| |care utilization. Ann Intern Med. 2001;135:313-321 |

| |Lazarus, B.A., Murphy, J.B., Coietta, E.M., McQuade, W.H., & Cuipepper, L. (1991). Ttie provision of physical activity to hospitalized elderly |

| |patients. Archives of Internal Medicine, 757(12), 2452-2456. |

| |Angela gillis, brenda MacDonald: prevention of deconditioning in the hospitalized elderly: Canadian nurse; 2005; 101(6)16-20. |

| |5Tinetti, M.E., Factors associated with serious injury during falls by ambulatory nursing home residents. J Am Geriatr Soc, 1987. 35(7): p. 644-8. |

| |Solange Czerniewicz, Claire M Nicholson: hale and hearty — the benefits of exercise in the elderly; cme; 2004; 22(11)629-635. |

| |Andersen CK, Wittrup-Jensen KU, Lolk A, Andersen K, and Kragh-Sorensen P. Ability to perform activities of daily living is the main factor affecting |

| |quality of life in patients with dementia. Health Qual Life Outcomes. 2004; 2:52. |

| |Lazowski DA, Ecclestone NA, Myers AM, et al. A randomized outcome evaluation of group exercise programs in long-term care institutions. J Gerontol A |

| |Biol Sci Med Sci. 1999; 54(12):M621-M628. |

| |Pham M, Pinganaud G, Richard-Harston S, Decamps A, Bourdel-Marchasson I. Prospective audit of diabetes care and outcomes in a group of geriatric |

| |French care homes. Diabetes Metab. 2003; 29(3):251-258. |

| |Richardson J, Bedard M, Weaver B. Changes in physical functioning in institutionalized older adults. Disabil Rehabil. 2001; 23(15):683-689. |

| |Wong AM, Lin YC, Chou SW, et al. Coordination exercises and postural stability in elderly people. Arch Phys Med Rehabil. 2001;82:608–612. |

| |McDermott AY, Mernitz H. Exercise and older patients:prescribing guidelines. Am Fam Physician.2006;74:437–444. |

| |Hauver K, Rost B, R¨utschle K, et al. Exercise training for rehabilitation and secondary prevention of falls in geriatric patients with a history of |

| |injurious falls. J Am Geriatr Soc. 2001;49:10–20. |

| |Skelton DA, Dinan SM. Exercise for falls management rationale for an exercise programme aimed at reducing postural instability. Physiother Theory |

| |Pract. 1999;15:105–120. |

| |Bert H Jacobson,Brennan Thompson,Tia Wallace, Brown, Christina; Independent static balance training contributes to increased stability and functional |

| |capacity in community-dwelling elderly people: a randomized controlled trial; clin rehabil;2011; 25(6)549-556. |

| |Arnaud D, P Diolez, Eric T, A. Tulon, C. Onifade, Tuan V, C. Helmer, Isabelle BM: Effect of exercise programs to prevent decline in health-related |

| |quality of life in highly deconditioned institutionalized elderly persons; Arch Intern Med; 2010; 170(2)162-169. |

| |Esma Ceceli, Figen Gon kog lu, Mine Ko yba¸si, Ozg ur C¸ ic¸ ek, Z. Rezan Yorgancio glu. The Comparison of Balance, Functional Activity, and |

| |Flexibility between Active and Sedentary Elderly. Topics in Geriatric Rehabilitation 2009; 25 (3). 198–202. |

| |Yung-Hui Tien, Kuei-Fu Li: The relationships between physical activity and static balance in elderly people; J Exerc Sci Fit; 2008;6(1)21-25. |

| |Tatjana B, Stephanie Hart-Hughes, Shahbaz Ahmed, Pat Quigley, Polly Palacios, Dennis C Werner, and Philip Foulis; Effect of a group-based exercise |

| |program on balance in elderly: Clin Interv Aging;2007;2(4);655–660. |

| |Catherine M Arnold and Robert A Faulkne; The history of falls and the association of the timed up and go test to falls and near-falls in older adults |

| |with hip osteoarthritis; BMC Geriatrics2007;7(17),doi:10.1186/1471-2318-7-17. |

| |Tomoko Yamauchi , Mohammod M. Islam , Daisuke Koizumi , Michael E. Rogers , Nicole L. Rogers And Nobuo Takeshima; Effect of home-based well-rounded |

| |exercise in community-dwelling older adults; Journal of Sports Science and Medicine ;2005; 4; 563-571. |

| |Solange Czerniewicz, Claire M Nicholson: hale and hearty — the benefits of exercise in the elderly; cme; 2004; 22(11)629-635. |

| |Susan L. Whitney, Gregory F. Marchetti, Annika Schade, Diane M. Wrisley; The sensitivity and specificity of the Timed "Up & Go" and the dynamic gait |

| |index for self-reported falls in persons with vestibular disorders; Journal of Vestibular R esearch;2004;14(5);397-409. |

| |Naomi Pollak , Wendy Rheault, Judith L. Stoecker :Reliability and validity of the FIM for persons aged 80 years and above from a multilevel |

| |continuing care retirement community.Archives of physical medicine and rehabilitation1996 ;77(10),1056-1061. |

| |Podsidlo D, Richardson S. The timed “up and go”: a test of basic functional mobility for frail elderly persons. J Am Geriat Soc: 1991; 39; 142-8. |

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|9. |Signature of the Candidate: |

|10. |Remarks of the guide: |

|11. |Name and Designation of |

| |11.1 Guide: |

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| |11.2 Signature: |

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| |11.3 Co-Guide : |

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| |11.4 Signature: |

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| |Head of Department: |

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| |11.6 Signature: |

|1.2 |12.1 Remarks of Principal: |

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| |Signature: |

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ANNEXURE –I

CONSENT FORM

I MULAY SNEHA SHRIKRISHNA have explained to................................the purpose of the research, the procedures required, and the possible risks and benefits to the best of my ability.

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

Investigator Signature Date

College:

Place:

CONSENT TO PARTICIPATE IN THE STUDY

Purpose of Research

I .........................have been informed that this study is for geriatrics like mine. All approaches /techniques are acceptable Physiotherapy interventions for this problem. This study will help physiotherapy better understand the use of Physiotherapy services in the management of balance, functional mobility and disability.

Procedure

I understand that I will be assigned to a group for flexibility or control. I will be expected to attend treatment sessions in the Physiotherapy department for 3 days in week for 4 weeks.

I am aware that in addition to ordinary care received, I will be examined and asked a series of questions by a research Physiotherapist. The Physiotherapist examination will consist of measuring balance, functional mobility and disabilty disability. I have been informed that these tests will be conducted at the beginning of the study, and after the study.

Risk and Discomforts

I understand that I may experience some pain or discomfort during the examination or during my treatment. This is mainly the result of my condition, as the procedure of this study is not expected to exaggerate these feelings which are associated with the usual course of treatment.

Benefits

I understand that my participation in the study will have no direct benefit to me other than potential benefit of the treatment which is planned to improve balance, functional mobility and disability. The major potential benefit is to find out which treatment program is more effective.

Confidentiality

I understand that the information produced by this study will became part of my research record and will be subject to the confidentiality and privacy regulation, but will be stored in the investigator’s research file.

If the data is used for publication in the literature or for the teaching purpose, no names will be used, and other identifiers, such as photographs and audio or videotapes, will be used without my special written permission.

Refusal or Withdrawal of Participation

I understand that my participation is voluntary and that I may refuse to participate or may withdraw consent and discontinue participation in the study at any time without prejudice to my present or future care at the Hospital. I also understand that MULAY SNEHA SHRIKRISHNA may terminate my participation in this study at any time after she explains the reasons for doing so.

I confirm that MULAY SNEHA SHRIKRISHNA has explained to me the purpose of this research, the study procedures that I will undergo, and the possible risks and discomforts as well as benefits that I may experience. Alternatives to my participation in the study have also been discussed. I have read and I understand this consent form. Therefore, I agree to give my consent to participate as a subject in this research project.

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Participant Signature Date

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Witness to Signature Date

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