Condition category
Circulatory System
Date applied
14/01/2010
Date assigned
09/02/2010
Last edited
09/02/2010
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 Dominique Hansen

ORCID ID

Contact details

Jessa Hospital
Stadsomvaart 11
Hasselt
3500
Belgium

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

07.48/cardio07.081

Study information

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

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

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Quality of life

Patient information sheet

Not available in web format, please use the contact details below to request a patient information sheet

Condition

Coronary artery disease

Intervention

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.

Intervention type

Other

Phase

Not Applicable

Drug names

Primary outcome measures

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 measures

1. Blood endothelial progenitor cell
2. Cytokine content

These measurements were executed at entry of rehabilitation, and after 7 weeks of rehabilitation.

Overall trial start date

01/02/2008

Overall trial end date

01/03/2010

Reason abandoned

Eligibility

Participant inclusion criteria

60 coronary artery disease (CAD) patients (aged between 45 - 80 years, either sex) agreed to participate in this study.

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

60

Participant 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

Recruitment start date

01/02/2008

Recruitment end date

01/03/2010

Locations

Countries of recruitment

Belgium

Trial participating centre

Jessa Hospital
Hasselt
3500
Belgium

Sponsor information

Organisation

Heart Centre Hasselt vzw (Belgium)

Sponsor details

Begeveldstraat
Bilzen
3740
Belgium

Sponsor type

Hospital/treatment centre

Website

http://www.jessazh.be/

Funders

Funder type

Hospital/treatment centre

Funder name

Heart Centre Hasselt vzw (Belgium)

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

Publication citations

Additional files

Editorial Notes