Condition category
Circulatory System
Date applied
23/01/2004
Date assigned
23/01/2004
Last edited
25/07/2011
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Dr Robert West

ORCID ID

Contact details

University of Wales College of Medicine
Department of Cardiology
WHRI Building
Heath Park
Cardiff
C4 4 XN
United Kingdom
+44 (0)1222 747747

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

http://www.doh.gov.uk

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

  1. Results

    Jones DA, West RR, Psychological rehabilitation after myocardial infarction: multicentre randomised controlled trial., BMJ, 1996, 313, 7071, 1517-1521.

Additional files

Editorial Notes