Promoting Physical Activity in the Over 65s (ProAct65+)
The recruitment status of this study is unknown because the information has not been verified recently.
Verified July 2010 by University College, London.
Recruitment status was Recruiting
Recruitment status was Recruiting
Sponsor:
University College, London
Collaborator:
University of Nottingham
Information provided by:
University College, London
ClinicalTrials.gov Identifier:
NCT00726531
First received: July 29, 2008
Last updated: July 7, 2010
Last verified: July 2010
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Purpose
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:
- 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).
- 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.
- To determine the acceptability of the programmes, adherence rates, enabling factors and barriers to future implementation.
- To determine participants' perceptions of the value of exercise, and the predictors of continued exercise.
| Condition | Intervention | Phase |
|---|---|---|
|
Falls |
Behavioral: Otago Exercise Programme Behavioral: Fame Other: Treatment As Usual |
Phase 3 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Single Blind (Outcomes Assessor) Primary Purpose: Prevention |
| 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 |
Resource links provided by NLM:
Further study details as provided by University College, London:
Primary Outcome Measures:
- type, intensity, duration and frequency of physical activity [ Time Frame: two years after intervention ] [ Designated as safety issue: No ]
| Estimated Enrollment: | 1200 |
| Study Start Date: | June 2008 |
| Estimated Study Completion Date: | May 2013 |
| Estimated Primary Completion Date: | May 2011 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: OEP
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: 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
|
|
Experimental: 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.
|
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.
|
|
No Intervention: TAU
Treatment as usual
|
Other: Treatment As Usual
Treatment as usual by the general practitioner
Other Name: Usual clinical care
|
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.
Eligibility| Ages Eligible for Study: | 65 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | Yes |
Criteria
Inclusion Criteria:
- Eligible patients will be those aged 65+ who can walk around at home (i.e. not chair or bed bound) and would be physically able to take part in a group exercise class, who are not already receiving any long term physiotherapy and who do not fulfill the exclusion criteria.
Exclusion Criteria:
- Chair or bed bound
- Receiving long-term physiotherapy
- Three or more falls in the previous year i.e. frequent fallers (only excluded if their GP does not consent to them taking part in exercise)
- Resting BP > 180/100 mmHg, tachycardia > 100bpm, uncontrolled hypertension
- Significant drop in BP during exercise
- Psychiatric conditions or physical abilities which would prevent participation in an exercise class (for example psychotic illness, acute systemic illness (e.g. pneumonia), uncontrolled visual or vestibular disturbances which the GP considers would exclude patients from undertaking the exercise programme, poorly controlled angina, acute rheumatoid arthritis, unstable or acute heart failure, or conditions requiring a specialist exercise programme e.g. uncontrolled epilepsy significant neurological disease or impairment, unable to maintain seated upright position or unable to move about independently indoors)
- Not living independently (e.g. residential care)
- Significant cognitive impairment (unable to follow simple instructions)
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00726531
Contacts
| Contact: Steve Iliffe, MB BS, BSc | 00442078302393 | s.iliffe@ucl.ac.uk |
Locations
| United Kingdom | |
| University College London | Recruiting |
| London, United Kingdom | |
| Principal Investigator: Steve Iliffe | |
| University of Nottingham | Recruiting |
| Nottingham, United Kingdom | |
| Principal Investigator: Denise Kendrick | |
Sponsors and Collaborators
University College, London
University of Nottingham
Investigators
| Study Director: | Denise Kendrick, PhD | University of Nottingham |
More Information
No publications provided
| Responsible Party: | Professor Steve Iliffe, University College London |
| ClinicalTrials.gov Identifier: | NCT00726531 History of Changes |
| Other Study ID Numbers: | ProAct65+, UK HTA grant 06/36/04 |
| Study First Received: | July 29, 2008 |
| Last Updated: | July 7, 2010 |
| Health Authority: | United Kingdom: Department of Health |
Keywords provided by University College, London:
|
Falls prevention Exercise promotion Older people |
ClinicalTrials.gov processed this record on May 21, 2013