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Sponsors and Collaborators: |
University College, London University of Nottingham |
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Information provided by: | University College, London |
ClinicalTrials.gov Identifier: | NCT00726531 |
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:
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:
Condition | Intervention | Phase |
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Falls |
Behavioral: Otago Exercise Programme Behavioral: Fame Other: Treatment As Usual |
Phase III |
Study Type: | Interventional |
Study Design: | Prevention, Randomized, Single Blind (Outcomes Assessor), Active Control, Parallel Assignment, Efficacy Study |
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 |
Estimated Enrollment: | 1200 |
Study Start Date: | June 2008 |
Estimated Study Completion Date: | November 2010 |
Estimated Primary Completion Date: | November 2010 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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OEP: Experimental
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
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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
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Fame: Experimental
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.
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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.
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TAU: No Intervention
Treatment as usual
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Other: Treatment As Usual
Treatment as usual by the general practitioner
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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.
Ages Eligible for Study: | 65 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
Exclusion Criteria:
United Kingdom | |
University College London | |
London, United Kingdom, NW3 2PF |
Study Director: | Denise Kendrick, PhD | University of Nottingham |
Responsible Party: | University College London ( Professor Steve Iliffe ) |
Study ID Numbers: | ProAct65+, UK HTA grant 06/36/04 |
Study First Received: | July 29, 2008 |
Last Updated: | August 4, 2008 |
ClinicalTrials.gov Identifier: | NCT00726531 |
Health Authority: | United Kingdom: Department of Health |
Falls prevention Exercise promotion Older people |