A community-based physical activity intervention to prevent mobility-related disability for retired older people (REtirement in ACTion (REACT)): study protocol for a randomised controlled trial.

Publisher: BioMed Central Country of Publication: England NLM ID: 101263253 Publication Model: Electronic Cited Medium: Internet ISSN: 1745-6215 (Electronic) Linking ISSN: 17456215 NLM ISO Abbreviation: Trials Subsets: MEDLINE

Original Publication: [London] : BioMed Central, 2006-

Community Health Services*/economics ; Exercise* ; Health Services for the Aged*/economics ; Mobility Limitation* ; Retirement* ; Sedentary Behavior*; Health Promotion/*methods; Activities of Daily Living ; Age Factors ; Aged ; Cost-Benefit Analysis ; Disability Evaluation ; England ; Female ; Geriatric Assessment/methods ; Health Care Costs ; Healthy Aging ; Humans ; Magnetic Resonance Imaging ; Male ; Multicenter Studies as Topic ; Pilot Projects ; Pragmatic Clinical Trials as Topic ; Risk Factors ; Time Factors

Background: The REtirement in ACTion (REACT) study is a multi-centre, pragmatic, two-arm, parallel-group randomised controlled trial (RCT) with an internal pilot phase. It aims to test the effectiveness and cost-effectiveness of a community, group-based physical activity intervention for reducing, or reversing, the progression of functional limitations in older people who are at high risk of mobility-related disability.
Methods/design: A sample of 768 sedentary, community-dwelling, older people aged 65 years and over with functional limitations, but who are still ambulatory (scores between 4 and 9 out of 12 in the Short Physical Performance Battery test (SPPB)) will be randomised to receive either the REACT intervention, delivered over a period of 12 months by trained facilitators, or a minimal control intervention. The REACT study incorporates comprehensive process and economic evaluation and a nested sub-study which will test the hypothesis that the REACT intervention will slow the rate of brain atrophy and of decline in cognitive function assessed using magnetic resonance imaging (MRI). Outcome data will be collected at baseline, 6, 12 and 24 months for the main study, with MRI sub-study data collected at baseline, 6 and 12 months. The primary outcome analysis (SPPB score at 24 months) will be undertaken blinded to group allocation. Primary comparative analyses will be on an intention-to-treat (ITT) basis with due emphasis placed on confidence intervals.
Discussion: REACT represents the first large-scale, pragmatic, community-based trial in the UK to target the non-disabled but high-risk segment of the older population with an intervention to reduce mobility-related disability. A programme that can successfully engage this population in sufficient activity to improve strength, aerobic capacity, coordination and balance would have a major impact on sustaining health and independence. REACT is also the first study of its kind to conduct a full economic and comprehensive process evaluation alongside the RCT. If effective and cost-effective, the REACT intervention has strong potential to be implemented widely in the UK and elsewhere.
Trial Registration: ISRCTN, ID: ISRCTN45627165 . Retrospectively registered on 13 June 2016. Trial sponsor: University of Bath. Protocol Version 1.5.

Health Psychol. 2004 Sep;23(5):443-51. (PMID: 15367063)
J Gerontol A Biol Sci Med Sci. 2005 Jul;60(7):894-900. (PMID: 16079214)
Pharmacoeconomics. 2008;26(9):769-79. (PMID: 18767897)
Med Decis Making. 1990 Jul-Sep;10(3):212-4. (PMID: 2115096)
Value Health. 2012 Jul-Aug;15(5):708-15. (PMID: 22867780)
J Gerontol A Biol Sci Med Sci. 2004 Feb;59(2):154-60. (PMID: 14999030)
BMC Health Serv Res. 2006 Apr 19;6:52. (PMID: 16623946)
J Gerontol A Biol Sci Med Sci. 2009 Feb;64(2):223-9. (PMID: 19182232)
N Engl J Med. 2003 Sep 11;349(11):1048-55. (PMID: 12968089)
Arch Phys Med Rehabil. 2014 Apr;95(4):753-769.e3. (PMID: 24291597)
Age Ageing. 2015 Jan;44(1):162-5. (PMID: 25313241)
Clin Pharmacol Ther. 1974 May;15(5):443-53. (PMID: 4597226)
BMJ. 2008 Sep 29;337:a1655. (PMID: 18824488)
Age Ageing. 2011 Jan;40(1):14-23. (PMID: 20843964)
Cost Eff Resour Alloc. 2013 Mar 25;11(1):6. (PMID: 23531194)
Lancet. 2013 Mar 2;381(9868):752-62. (PMID: 23395245)
Biometrics. 1975 Mar;31(1):103-15. (PMID: 1100130)
Health Psychol Rev. 2017 Jun;11(2):145-163. (PMID: 28281891)
PLoS One. 2014 May 27;9(5):e97676. (PMID: 24866573)
BMJ. 2015 Mar 19;350:h1258. (PMID: 25791983)
JAMA. 2014 Jun 18;311(23):2387-96. (PMID: 24866862)
Pharmacoeconomics. 2014 Dec;32(12):1157-70. (PMID: 25069632)
BMC Public Health. 2011 Feb 18;11:119. (PMID: 21333011)

MR/P021220/1 United Kingdom MRC_ Medical Research Council; United Kingdom WT_ Wellcome Trust; PHR/13/164/51 United Kingdom DH_ Department of Health; 13/164/51 United Kingdom DH_ Department of Health

Keywords: Disability prevention; Frailty; Mobility disability; Older adults; Physical activity; Physical function; Randomised control trial

Date Created: 20180419 Date Completed: 20190618 Latest Revision: 20240314

20250114

PMC5905123

10.1186/s13063-018-2603-x

29665854