Falls Clinical Trial
Official title:
Multi-centre Cluster Randomised Trial Comparing a Community Group Exercise Programme With Home Based Exercise With Usual Care for Over 65s in Primary Care
The aim of the project is to evaluate the delivery, impact and cost effectiveness of a
community based exercise programme (FaME); compared to a home based exercise programme (OEP)
supported by similarly aged mentors; compared with usual care for primary care patients.
Primary Objective:
1. To determine the effect on continuation of exercise of two evidence based exercise
programmes designed for older people, compared with usual care i.e. with no special
interventions to promote physical activity.
Secondary Objective:
2. To determine the health benefits of the programmes to patients starting at various
levels of physical activity, particularly the effects on physical and psychological
status, health status and quality adjusted life years (QALYs).
3. To estimate the costs of the exercise interventions and to assess the
cost-effectiveness of community group exercise, and home-supported exercise compared
with usual care.
4. To determine the acceptability of the programmes, adherence rates, enabling factors and
barriers to future implementation.
5. To determine participants' perceptions of the value of exercise, and the predictors of
continued exercise.
A cluster controlled trial using minimisation for allocation at the level of general practice in two centres (London and Nottingham/Derby), to compare a community-centre based group exercise programme - FaME [delivered by specifically trained postural stability instructors (PSIs) and supplemented by home exercise and prescriptive recommendations for walking], with a home based exercise programme and walking plan - OEP [supported by specifically trained and similarly aged mentors], with two years follow-up to determine the impact, acceptability and adherence to the programme, and longer term continuation of exercise. Control subjects will continue to receive usual care in primary care. A cost-effectiveness analysis will be conducted within the study. ;
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Prevention
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