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01.12.2018 | Study protocol | Ausgabe 1/2018 Open Access

Trials 1/2018

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

Zeitschrift:
Trials > Ausgabe 1/2018
Autoren:
Afroditi Stathi, Janet Withall, Colin J. Greaves, Janice L. Thompson, Gordon Taylor, Antonieta Medina-Lara, Colin Green, James Bilzon, Selena Gray, Heidi Johansen-Berg, Claire E. Sexton, Max J. Western, Jolanthe L. de Koning, Jessica C. Bollen, Sarah J. Moorlock, Naiara Demnitz, Poppy Seager, Jack M. Guralnik, W. Jack Rejeski, Ken R. Fox
Wichtige Hinweise

Electronic supplementary material

The online version of this article (https://​doi.​org/​10.​1186/​s13063-018-2603-x) contains supplementary material, which is available to authorized users.

Abstract

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.
Zusatzmaterial
Additional file 1: Completed SPIRIT (2013) Checklist detailing on which page of the protocol manuscript each of the relevant recommended items is addressed. (DOC 123 kb)
13063_2018_2603_MOESM1_ESM.doc
Additional file 3: REACT process evaluation protocol and Logic model. (DOCX 128 kb)
13063_2018_2603_MOESM3_ESM.docx
Additional file 4: REACT Telephone Screening Form used to collect demographic data and undergo and initial eligibility assessment with potential participants. (DOCX 149 kb)
13063_2018_2603_MOESM4_ESM.docx
Additional file 5: REACT Participant Consent Form. (DOCX 135 kb)
13063_2018_2603_MOESM5_ESM.docx
Literatur
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