The Home-Based Older People's Exercise (HOPE) trial: study protocol for a randomised controlled trial

详细信息    查看全文

• 作者：Andrew Clegg (1)
  Sally Barber (1)
  John Young (1)
  Anne Forster (1)
  Steve Iliffe (2)
  
• 刊名：Trials
• 出版年：2011
• 出版时间：December 2011
• 年：2011
• 卷：12
• 期：1
• 全文大小：319KB
• 参考文献：1. Walston J, Hadley EC, Ferrucci L, Guralnik JM, Newman AB, Studenski SA, Ershler WB, Harris T, Fried LP: Research agenda for frailty in older adults: toward a better understanding of physiology and etiology: summary from the American Geriatrics Society/National Institute on Aging Research Conference on Frailty in Older Adults. / J Am Geriatr Soc 2006,54(6):991鈥?001. CrossRef
  2. Fried LP, Tangen CM, Walston J, Newman AB, Hirsch C, Gottdiener J, Seeman T, Tracy R, Kop WJ, Burke G, McBurnie MA: Frailty in older adults: evidence for a phenotype. / J Gerontol A Biol Sci Med Sci 2001,56(3):M146鈥?6. CrossRef
  3. Syddall H, Roberts HC, Evandrou M, Cooper C, Bergman H, Aihie Sayer A: Prevalence and correlates of frailty among community-dwelling older men and women. / Age Ageing 2010,39(2):197鈥?03. CrossRef
  4. Rockwood K, Song X, MacKnight C, Bergman H, Hogan DB, McDowell I, Mitnitski A: A global clinical measure of fitness and frailty in elderly people. / CMAJ 2005,173(5):489鈥?5. CrossRef
  5. Poole T: / Funding adult social care in England. The Kings Fund; March; 2009:1鈥?1.
  6. Forster A, Lambley R, Hardy J, Young J, Smith J, Green J, Burns E: Rehabilitation for older people in long-term care. Cochrane database of systematic reviews. 2009.,1(CD004294):
  7. Department for Work and Pensions: / Focus on Older People. London: Office for National Statistics; 2004.
  8. Ashworth NL, Chad KE, Harrison EL, Reeder BA, Marshall SC: Home versus center based physical activity programs in older adults. / Cochrane Database Syst Rev 2005, (1):CD004017.
  9. Our health, our care, our say: a new direction for community services Department of Health, London; 2006.
  10. Medical Research Council: / Developing and evaluating complex interventions: new guidance. London: MRC; 2008.
  11. Ferrucci L, Guralnik JM, Studenski S, Fried LP, Cutler GB Jr, Walston JD: Designing randomized, controlled trials aimed at preventing or delaying functional decline and disability in frail, older persons: a consensus report. / J Am Geriatr Soc 2004,52(4):625鈥?4. CrossRef
  12. Nelson ME, Rejeski WJ, Blair SN, Duncan PW, Judge JO, King AC, Macera CA, Castaneda-Sceppa C: Physical activity and public health in older adults: recommendation from the American College of Sports Medicine and the American Heart Association. / Med Sci Sports Exerc 2007,39(8):1435鈥?5. CrossRef
  13. Forster A, Lambley R, Young JB: Is physical rehabilitation for older people in long-term care effective? Findings from a systematic review. / Age Ageing 2010,39(2):169鈥?5. CrossRef
  14. Linstone H, Turoff M: / The Delphi method: techniques and applications. Reading, MA: Adison-Wesley; 1975.
  15. Podsiadlo D, Richardson S: The timed "Up & Go": a test of basic functional mobility for frail elderly persons. / J Am Geriatr Soc 1991,39(2):142鈥?.
  16. Abraham C, Michie S: A taxonomy of behavior change techniques used in interventions. / Health Psychol 2008,27(3):379鈥?7. CrossRef
  17. Baker G, Gray SR, Wright A, Fitzsimons C, Nimmo M, Lowry R, Mutrie N: The effect of a pedometer-based community walking intervention "Walking for Wellbeing in the West" on physical activity levels and health outcomes: a 12-week randomized controlled trial. / Int J Behav Nutr Phys Act 2008, 5:44.
  18. Hughes AR, Gillies F, Kirk AF, Mutrie N, Hillis WS, MacIntyre PD: Exercise consultation improves short-term adherence to exercise during phase IV cardiac rehabilitation: a randomized, controlled trial. / J Cardiopulm Rehabil 2002,22(6):421鈥?. CrossRef
  19. Kirk A, Mutrie N, MacIntyre P, Fisher M: Effects of a 12-month physical activity counselling intervention on glycaemic control and on the status of cardiovascular risk factors in people with Type 2 diabetes. / Diabetologia 2004,47(5):821鈥?2. CrossRef
  20. Thabane L, Ma J, Chu R, Cheng J, Ismaila A, Rios LP, Robson R, Thabane M, Giangregorio L, Goldsmith CH: A tutorial on pilot studies: the what, why and how. / BMC Med Res Methodol 2010, 10:1. CrossRef
  21. Charlson M, Szatrowski TP, Peterson J, Gold J: Validation of a combined comorbidity index. / J Clin Epidemiol 1994,47(11):1245鈥?1. CrossRef
  22. Rolfson DB, Majumdar SR, Tsuyuki RT, Tahir A, Rockwood K: Validity and reliability of the Edmonton Frail Scale. / Age Ageing 2006,35(5):526鈥?. CrossRef
  23. Wright AA, Cook CE, Baxter GD, Dockerty JD, Abbott JH: A comparison of 3 methodological approaches to defining major clinically important improvement of 4 performance measures in patients with hip osteoarthritis. / J Orthop Sports Phys Ther 41(5):319鈥?7.
  24. Mahoney FI, Barthel DW: Functional Evaluation: The Barthel Index. / Md State Med J 1965, 14:61鈥?.
  25. Hsieh YW, Wang CH, Wu SC, Chen PC, Sheu CF, Hsieh CL: Establishing the minimal clinically important difference of the Barthel Index in stroke patients. / Neurorehabil Neural Repair 2007,21(3):233鈥?. CrossRef
  26. Wellwood I, Dennis MS, Warlow CP: A comparison of the Barthel Index and the OPCS disability instrument used to measure outcome after acute stroke. / Age Ageing 1995,24(1):54鈥?. CrossRef
  27. The EuroQol Group: EuroQol-a new facility for the measurement of health-related quality of life. / Health Policy 1990,16(3):199鈥?08. CrossRef
  28. Sheikh JI, Yesavage JA, Brooks JO, Friedman L, Gratzinger P, Hill RD, Zadeik A, Crook T: Proposed factor structure of the Geriatric Depression Scale. / Int Psychogeriatr 1991,3(1):23鈥?. CrossRef
  29. Department for Constitutional Affairs: / Mental Capacity Act 2005 Code of Practice. TSO (The Stationery Office), London; 2007.
  30. International Committee on Harmonisation Good Clinical Practice (ICH-GCP) Guidelines [http://www.ich.org/products/guidelines.html] 2005.
  31. Lawton BA, Rose SB, Elley CR, Dowell AC, Fenton A, Moyes SA: Exercise on prescription for women aged 40鈥?4 recruited through primary care: two year randomised controlled trial. / BMJ 2008, 337:a2509. CrossRef
  
• 作者单位：Andrew Clegg (1)
  Sally Barber (1)
  John Young (1)
  Anne Forster (1)
  Steve Iliffe (2)
  
  1. Academic Unit of Elderly Care & Rehabilitation, University of Leeds, Bradford Institute for Health Research, Bradford Teaching Hospitals NHS Foundation Trust, Duckworth Lane, Bradford, BD9 6RJ, UK
  2. Department of Primary Care and Population Health, University College London, Rowland Hill St, London, NW3 2PF, UK
  

文摘

Background Frailty is common in older age, and is associated with important adverse health outcomes including increased risk of disability and admission to hospital or long-term care. Exercise interventions for frail older people have the potential to reduce the risk of these adverse outcomes by increasing muscle strength and improving mobility. Methods/Design The Home-Based Older People's Exercise (HOPE) trial is a two arm, assessor blind pilot randomised controlled trial (RCT) to assess the effectiveness of a 12 week exercise intervention (the HOPE programme) designed to improve the mobility and functional abilities of frail older people living at home, compared with usual care. The primary outcome is the timed-up-and-go test (TUGT), measured at baseline and 14 weeks post-randomisation. Secondary outcomes include the Barthel Index of activities of daily living (ADL), EuroQol Group 5-Dimension Self-Report Questionnaire (EQ-5D) quality of life measure and the geriatric depression scale (GDS), measured at baseline and 14 weeks post-randomisation. We will record baseline frailty using the Edmonton Frail Scale (EFS), record falls and document muscle/joint pain. We will test the feasibility of collection of data to identify therapy resources required for delivery of the intervention. Discussion The HOPE trial will explore and evaluate a home-based exercise intervention for frail older people. Although previous RCTs have used operationalised, non-validated methods of measuring frailty, the HOPE trial is, to our knowledge, the first RCT of an exercise intervention for frail older people that includes a validated method of frailty assessment at baseline. Trial registration ISRCTN: ISRCTN57066881