Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
RRCC860F WATHALL
Study information
Scientific title
Acronym
Study hypothesis
Not provided at time of registration
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
Not specified
Trial type
Not Specified
Patient information sheet
Not available in web format, please use the contact details below to request a patient information sheet
Condition
Cardiovascular diseases: Heart disease
Intervention
1. Goal-setting and pacing
2. Standard care
3. Attention control procedure
Intervention type
Other
Phase
Not Applicable
Drug names
Primary outcome measures
The primary outcome will be an increase in fitness measured in (METS) using a standardised exercise test. The patients will also keep an activity diary. Other variables to be measured will include anxiety and depression (Hospital Anxiety and Depression Scale), health beliefs (Illness Perception Questionnaire), this questionnaire has been shown to predict a number of aspects of recovery in post-MI patients, medical co-morbidity, the number of acute events (including hospital admissions), the number of consultations for cardiac reasons, risk factor profile, a cumulative secondary prevention score (using the method of the ASPIRE group), systolic and diastolic blood pressure at rest and following exercise and the EuroQU0L, a measure of health-related quality of life. All of these measures have been validated for use in this patient group and will be piloted during Phase 1 for suitability when other measures may be added.
Secondary outcome measures
Not provided at time of registration
Overall trial start date
08/01/2000
Overall trial end date
03/01/2003
Reason abandoned
Eligibility
Participant inclusion criteria
Coronary care patients
Participant type
Patient
Age group
Not Specified
Gender
Not Specified
Target number of participants
Not provided at time of registration
Participant exclusion criteria
Patients who would normally be offered rehabilitation classes
Recruitment start date
08/01/2000
Recruitment end date
03/01/2003
Locations
Countries of recruitment
United Kingdom
Trial participating centre
94 Huntington Road
York
YO31 8RP
United Kingdom
Sponsor information
Organisation
NHS R&D Regional Programme Register - Department of Health (UK)
Sponsor details
The Department of Health
Richmond House
79 Whitehall
London
SW1A 2NL
United Kingdom
+44 (0)20 7307 2622
dhmail@doh.gsi.org.uk
Sponsor type
Government
Website
Funders
Funder type
Government
Funder name
NHS Executive Northern and Yorkshire (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