A randomised controlled trial (RCT) of the cost-effectiveness of exercise in the over 65s

ISRCTN	ISRCTN17437980
DOI	https://doi.org/10.1186/ISRCTN17437980
Secondary identifying numbers	BP8

Submission date: 23/01/2004
Registration date: 23/01/2004
Last edited: 31/05/2011

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Other

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English summary of protocol

Not provided at time of registration

Contact information

Dr James Munro
Scientific

Medical Care Research Unit
University of Sheffield
Regent Court
30 Regent Street
Sheffield
S1 4DA
United Kingdom

Phone	+44 (0)114 222 5202
Email	j.f.munro@sheffield.ac.uk

Study information

Study design	Randomised controlled trial
Primary study design	Interventional
Secondary study design	Randomised controlled trial
Study setting(s)	Other
Study type	Not Specified
Scientific title
Study objectives	The overall aim of the study was to quantify the cost-effectiveness of inviting a population of older adults to a community-based programme of exercise, whether or not the invitation was taken up, as an intervention to prevent or delay illness due to coronary heard disease (CHD), stroke, diabetes, mental illness or hip fracture, and to promote health and well-being. The specific objectives of the study were: 1. To assess older adults' participation and adherence to a free and locally available exercise programme; 2. To evaluate the effect of such a programme on individual and population physical activity, quality of life, mortality, and use of health care; 3. To estimate the cost-effectiveness of the programme, if it proves to result in health gains. Diseases areas: Cardiovascular diseases: Cerebrovascular disease; Cardiovascular diseases: Heart disease; Injury, occupational diseases, poisoning: Musculoskeletal injury; Mental and behavioural disorders: Depression, anxiety, neuroses; Nutritional, metabolic and endocrine diseases: Diabetes.
Ethics approval(s)	Not provided at time of registration
Health condition(s) or problem(s) studied	Cardiovascular diseases: Cerebrovascular disease; Cardiovascular diseases: Heart disease; Injury, occupational diseases, poisoning: Musculoskeletal injury; Mental and behavioural disorders: Depression, anxiety, neuroses; Nutritional, metabolic and endocrine diseases: Diabetes
Intervention	The intervention was defined pragmatically as invitation to a locally organised, free and regular programme of exercise classes. Each class was arranged to run weekly, at the same time and place each week, and usually led by the same exercise leader. In any week there would typically be four or five different classes available, run from two or three venues, and participants were encouraged to aim to attend at least two classes per week. Most classes were held in church halls, community centres and less frequently in residential homes. Control participants were not invited to partake in the exercise classes.
Intervention type	Other
Primary outcome measure	The major study outcomes were all-cause and exercise-related mortality, health service use, and health status. Mortality and health service use were assessed using routine NHS data. Health status was assessed by means of postal survey at baseline, 12 and 24 months using the SF-36 instrument. In addition an economic evaluation was undertaken of the cost-utility of the programme using a preference-based single index of health status derived from the SF-36.
Secondary outcome measures	Not provided at time of registration
Overall study start date	01/09/1994
Completion date	31/12/1997

Eligibility

Participant type(s)	Patient
Age group	Senior
Sex	Both
Target number of participants	Not provided at time of registration
Key inclusion criteria	The subjects of the trial were the populations of 12 general practices in Sheffield, of which four were randomly selected as intervention populations, and eight as control populations. In each intervention population the least active four-fifths of those aged 65 and over were invited to attend free supervised exercise sessions in local community settings.
Key exclusion criteria	Not provided at time of registration
Date of first enrolment	01/09/1994
Date of final enrolment	31/12/1997

Locations

Countries of recruitment

England
United Kingdom

Study participating centre

Medical Care Research Unit

Sheffield
S1 4DA
United Kingdom

Sponsor information

Record Provided by the NHS R&D 'Time-Limited' National Programme Register - Department of Health (UK)
Government

The Department of Health
Richmond House
79 Whitehall
London
SW1A 2NL
United Kingdom

Website	http://www.doh.gov.uk

Funders

Funder type

Government

NHS Cardiovascular Disease and Stroke National Research and Development Programme (UK)

No information available

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
Publication and dissemination plan	Not provided at time of registration
IPD sharing plan

Study outputs

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Results article	results	01/12/1997		Yes	No