|
ISRCTN
|
ISRCTN81212339
|
|
ClinicalTrials.gov identifier
|
|
|
Public title
|
Clinical benefits of additional resistance-type exercise during an endurance-type exercise intervention in coronary artery disease patients
|
|
Scientific title
|
Clinical benefits of additional resistance-type exercise during an endurance-type exercise intervention in coronary artery disease patients: a randomised controlled trial
|
|
Acronym
|
STIMCARE
|
|
Serial number at source
|
07.48/cardio07.081
|
|
Study hypothesis
|
We hypothesise that by adding resistance-type exercise during an endurance-type exercise intervention, significantly greater clinical benefits are achieved in coronary artery disease patients.
|
|
Ethics approval
|
Medical Ethical Committee of Jessa Hospital approved on the 29th January 2007 (ref: 07.48/cardio07.081)
|
|
Study design
|
Prospective randomised clinical trial
|
|
Countries of recruitment
|
Belgium
|
|
Disease/condition/study domain
|
Coronary artery disease
|
|
Participants - inclusion criteria
|
60 coronary artery disease (CAD) patients (aged between 45 - 80 years, either sex) agreed to participate in this study.
|
|
Participants - exclusion criteria
|
1. Complicated hospitalisation (renal failure, sepsis)
2. Delayed and/or complicated sternum healing
3. Hypertension (greater than 150 mmHg systolic blood pressure at rest and/or greater than 250 mmHg systolic blood pressure during exercise)
4. Presence of pulmonary and renal co-morbidity
5. Peripheral artery disease
6. Orthopaedic limitations
7. Subjects presenting myocardial ischaemia and/or severe ventricular arrhythmias during baseline exercise testing
|
|
Anticipated start date
|
01/02/2008
|
|
Anticipated end date
|
01/03/2010
|
|
Status of trial
|
Completed |
|
Patient information material
|
Not available in web format, please use the contact details below to request a patient information sheet
|
|
Target number of participants
|
60
|
|
Interventions
|
All subjects exercised under close supervision of experienced physiotherapists three days per week for a total duration of six weeks in the cardiac rehabilitation centre of the hospital. Exercise training intensity was determined by baseline VO2 peak assessment: subjects exercised at a heart rate corresponding to 65% of baseline VO2 peak, for 40 minutes each exercise training session (17 minutes cycling, 13 minutes walking, 10 minutes arm cranking). Subjects were randomly (by coin) assigned to an endurance-training group, or combined endurance and strength-training group.
|
|
Primary outcome measure(s)
|
1. Maximal exercise capacity
2. Sub-maximal exercise capacity
3. Muscle strength
4. Blood plasma lipid profile and glycaemic control
5. Habitual activity level
These measurements were executed at entry of rehabilitation, and after 7 weeks of rehabilitation.
|
|
Secondary outcome measure(s)
|
1. Blood endothelial progenitor cell
2. Cytokine content
These measurements were executed at entry of rehabilitation, and after 7 weeks of rehabilitation.
|
|
Sources of funding
|
Heart Centre Hasselt vzw (Belgium)
|
|
Trial website
|
|
|
Publications
|
|
|
Contact name
|
Dr
Dominique
Hansen
|
|
Address
|
Jessa Hospital
Stadsomvaart 11
|
|
City/town
|
Hasselt
|
|
Zip/Postcode
|
3500
|
|
Country
|
Belgium
|
|
Sponsor
|
Heart Centre Hasselt vzw (Belgium)
|
|
Address
|
Begeveldstraat
|
|
City/town
|
Bilzen
|
|
Zip/Postcode
|
3740
|
|
Country
|
Belgium
|
|
Sponsor website:
|
http://www.jessazh.be/
|
|
Date applied
|
14/01/2010
|
|
Last edited
|
09/02/2010
|
|
Date ISRCTN assigned
|
09/02/2010
|