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.
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.


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.


CONCLUSIONS
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.


BACKGROUND
Trial Registration: ISRCTN43453770.
Iliffe
Steve
S
Department of Primary Care & Population Health, University College London, Rowland Hill St, London NW3 2PF, UK. s.iliffe@pcps.ucl.ac.uk
Kendrick
Denise
D
Morris
Richard
R
Skelton
Dawn
D
Gage
Heather
H
Dinan
Susie
S
Stevens
Zoe
Z
Pearl
Mirilee
M
Masud
Tahir
T
D000058:Accidental Falls / Q000517:prevention & control; D000368:Aged; D016000:Cluster Analysis; D003153:Community Health Services / Q000191:economics; D003362:Cost-Benefit Analysis; D004739:England; D005081:Exercise Therapy / Q000191:economics; D005239:Fear / Q000523:psychology; D017048:Health Care Costs; D006299:Health Services for the Aged / Q000191:economics; D006699:Home Care Services / Q000191:economics; D006801:Humans; D010349:Patient Compliance; D010379:Peer Group; D011320:Primary Health Care / Q000191:economics; D011788:Quality of Life; D012107:Research Design; D013997:Time Factors; D016896:Treatment Outcome