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Multi-centre cluster randomised trial comparing a community group exercise programme with home based exercise with usual care for people aged 65 and over in primary care: protocol of the ProAct 65+ trial

Steve Iliffe1*, Denise Kendrick2, Richard Morris1, Dawn Skelton3, Heather Gage4, Susie Dinan1, Zoe Stevens1, Mirilee Pearl1 and Tahir Masud5

Author Affiliations

1 Department of Primary Care & Population Health, University College London, Rowland Hill St, London NW3 2PF, UK

2 Division of Primary Care, University of Nottingham, Tower Building, University Park, Nottingham, NG7 2RD, UK

3 School of Health, HealthQWest, Glasgow Caledonian University, Cowcaddens Road, Glasgow, G4 0BA, UK

4 Department of Economics, University of Surrey, Guildford, GU2 7XH, UK

5 Department of Health Care for Older People, Nottingham University Hospitals NHS Trust, Nottingham, UK

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Trials 2010, 11:6  doi:10.1186/1745-6215-11-6

Published: 18 January 2010

Abstract

Background

Regular physical activity reduces the risk of mortality from all causes, with a powerful beneficial effect on risk of falls and hip fractures. However, physical activity levels are low in the older population and previous studies have demonstrated only modest, short-term improvements in activity levels with intervention.

Design/Methods

Pragmatic 3 arm parallel design cluster controlled trial of class-based exercise (FAME), home-based exercise (OEP) and usual care amongst older people (aged 65 years and over) in primary care. The primary outcome is the achievement of recommended physical activity targets 12 months after cessation of intervention. Secondary outcomes include functional assessments, predictors of exercise adherence, the incidence of falls, fear of falling, quality of life and continuation of physical activity after intervention, over a two-year follow up. An economic evaluation including participant and NHS costs will be embedded in the clinical trial.

Discussion

The ProAct65 trial will explore and evaluate the potential for increasing physical activity among older people recruited through general practice. The trial will be conducted in a relatively unselected population, and will address problems of selective recruitment, potentially low retention rates, variable quality of interventions and falls risk.

Trial Registration

Trial Registration: ISRCTN43453770