Contact information
Type
Scientific
Primary contact
Dr James Munro
ORCID ID
Contact details
Medical Care Research Unit
University of Sheffield
Regent Court
30 Regent Street
Sheffield
S1 4DA
United Kingdom
+44 (0)114 222 5202
j.f.munro@sheffield.ac.uk
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
BP8
Study information
Scientific title
Acronym
Study hypothesis
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
Not provided at time of registration
Study design
Randomised controlled trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Other
Trial type
Not Specified
Patient information sheet
Condition
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
Phase
Not Specified
Drug names
Primary outcome measures
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 trial start date
01/09/1994
Overall trial end date
31/12/1997
Reason abandoned
Eligibility
Participant 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.
Participant type
Patient
Age group
Senior
Gender
Both
Target number of participants
Not provided at time of registration
Participant exclusion criteria
Not provided at time of registration
Recruitment start date
01/09/1994
Recruitment end date
31/12/1997
Locations
Countries of recruitment
United Kingdom
Trial participating centre
Medical Care Research Unit
Sheffield
S1 4DA
United Kingdom
Sponsor information
Organisation
Record Provided by the NHS R&D 'Time-Limited' National Programme Register - Department of Health (UK)
Sponsor details
The Department of Health
Richmond House
79 Whitehall
London
SW1A 2NL
United Kingdom
Sponsor type
Government
Website
Funders
Funder type
Government
Funder name
NHS Cardiovascular Disease and Stroke National Research and Development Programme (UK)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Results - basic reporting
Publication summary
1997 results in http://www.ncbi.nlm.nih.gov/pubmed/9467144
Publication citations
-
Results
Munro J, Brazier J, Davey R, Nicholl J, Physical activity for the over-65s: could it be a cost-effective exercise for the NHS?, J Public Health Med, 1997, 19, 4, 397-402.