Clinical trial NCT00726531: Promoting Physical Activity in the Over 65s
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
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE3
Conditions: Falls
Keywords: Falls prevention
Exercise promotion
Older people
Lead sponsor: University College, London
Sponsor class: OTHER
Collaborators: name: University of Nottingham
First posted: 2008-08-01
Enrollment: 1200
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief 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.

Eligibility 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)

Primary outcomes:
measure: type, intensity, duration and frequency of physical activity
timeFrame: two years after intervention
Secondary outcomes:
Other outcomes:
Locations:
city: London
country: United Kingdom
facility: University College London
city: Nottingham
country: United Kingdom
facility: University of Nottingham
Study officials:
affiliation: University of Nottingham
name: Denise Kendrick, PhD
role: STUDY_DIRECTOR
References: