Promoting Physical Activity in the Over 65s (NCT00726531) | Clinical Trial Compass
UnknownPhase 3
Promoting Physical Activity in the Over 65s
United Kingdom1,200 participantsStarted 2008-06
Plain-language 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.
Who can participate
Age range
65 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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)
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
type, intensity, duration and frequency of physical activity