NCT00726531

Promoting Physical Activity in the Over 65s

Multi-centre Cluster Randomised Trial Comparing a Community Group Exercise Programme With Home Based Exercise With Usual Care for Over 65s in Primary Care

• Status: Unknown
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 1,200 (estimated)
• Sponsor: University College, London · Academic / Other
• Sex: All
• Age: 65 Years
• Healthy volunteers: Accepted

Summary

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.

Detailed description

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.

Conditions

• Falls

Interventions

Type	Name	Description
BEHAVIORAL	Otago Exercise Programme	Home based exercise programme (OEP) This exercise programme consists of a 30 minute programme of leg muscle strengthening and balance retraining exercises progressing in difficulty to be performed at home at least three times per week, and a walking plan to be undertaken at least two times per week for 24 weeks. . Trained peer mentors will contact and visit the patients at their home to start the exercise programme with them and will follow-up with up to three more home visits / exercise sessions as the participants require
BEHAVIORAL	Fame	Community based exercise programme (FaME) FaME includes and extends the OEP. It will comprise one hour PSI delivered group exercise class in a local community centre for a maximum of 15 participants, and two 30 minute home exercise sessions (based on the extended OEP) per week for 24 weeks. Participants will also be advised to walk at least twice per week for up to 30 minutes at a moderate pace.
OTHER	Treatment As Usual	Treatment as usual by the general practitioner

Timeline

• Start date: 2008-06-01
• Primary completion: 2011-05-01
• Completion: 2013-05-01
• First posted: 2008-08-01
• Last updated: 2010-07-08

Locations

2 sites across 1 country: United Kingdom