Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
RM19
Study information
Scientific title
Acronym
Study hypothesis
There is little evidence for effectiveness of cardiac rehabilitation following acute myocardial infarction as currently provided in the NHS and in the context of modern therapeutic practice. There are few recent trials and historic trials may be of little relevance, since treatments in cardiac care units, with thrombolysis, aspirin, ß blocker, ACE inhibitor and statins have changed greatly in the past thirty years.
The principal objective was to determine the effectiveness of programmes of cardiac rehabilitation, as currently provided and in the current clinical context. The trial aimed to measure the effect of rehabilitation on mortality, morbidity and quality of life of patients following myocardial infarction. Further aims included identification of programmes that are more or less effective and of characteristics of patients who benefit more or less from cardiac rehabilitation and to estimate costs of cardiac rehabilitation.
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
Hospitals
Trial type
Not Specified
Patient information sheet
Condition
Cardiovascular diseases: Heart disease
Intervention
1. Comprehensive cardiac rehabilitation
2. Standard care
Intervention type
Other
Phase
Not Specified
Drug names
Primary outcome measures
Outcomes at one year included mortality, morbidity, cardiac medication, health service use, psychological wellbeing and quality of life on standard scales, cardiac risk factors, including smoking, drinking, diet and leisure time activity.
Secondary outcome measures
Not provided at time of registration
Overall trial start date
01/04/1996
Overall trial end date
01/04/2000
Reason abandoned
Eligibility
Participant inclusion criteria
Not provided at time of registration
Participant type
Patient
Age group
Not Specified
Gender
Not Specified
Target number of participants
Not provided at time of registration
Participant exclusion criteria
Not provided at time of registration
Recruitment start date
01/04/1996
Recruitment end date
01/04/2000
Locations
Countries of recruitment
United Kingdom
Trial participating centre
University of Wales College of Medicine
Cardiff
C4 4 XN
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
1. 1996 results in http://www.ncbi.nlm.nih.gov/pubmed/8978226
Publication citations
-
Results
Jones DA, West RR, Psychological rehabilitation after myocardial infarction: multicentre randomised controlled trial., BMJ, 1996, 313, 7071, 1517-1521.