- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02228603
Exercise as a Life-long Medicine in Patients With Coronary Artery Disease
How to Enhance Physical Activity After Cardiac Rehabilitation? A Randomised Controlled Study Comparing Two Follow-up Training Exercise Programs
Exercise training is a core component in cardiac rehabilitation. Exercise adherence is, however, low after rehabilitation and the transition from supervised to unsupervised exercise is problematic for many patients with coronary artery disease. Therefore, it is important to provide extended services to improve exercise adherence and healthy lifestyle changes.
The aim of this study is to assess the effect of a time-limited intervention following out-patient cardiac rehabilitation on exercise adherence and cardiovascular risk reduction.
Study Overview
Status
Intervention / Treatment
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
-
Levanger, Norway
- Levanger Hospital
-
Trondheim, Norway
- St Olavs Hospital
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- myocardial infarction, stable angina, heart surgery
- finished phase 2 cardiac rehabilitation
- clinically stable
- able to communicate in Norwegian
- able to do a maximal treadmill test
Exclusion Criteria:
- unstable angina
- serious cardiac arrhythmia
- serious heart valve insufficiency
- heart failure
- any contraindication for high intensity exercise training
- participation in other exercise study
- pregnancy
- cognitive impairment
- drug abuse
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: high-intensity exercise
community-based group program: weekly supervised high-intensity exercise training during 8 weeks, followed by group counselling every third month for 12 months
|
|
Active Comparator: web-based follow-up
web-based follow-up program: home-based group will be followed up by mail and telephone calls the first 8 weeks, then every third month for 12 months
|
|
Other: control
control group will receive usual care: information about recommended physical activity and healthy lifestyle
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
change in peak oxygen uptake
Time Frame: 2 years
|
measured during exercise on treadmill (MetaMax Cortex/Innocor)
|
2 years
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
physical activity
Time Frame: 2 years
|
assessed by accelerometer SenseWear Armband Pro
|
2 years
|
quality of life
Time Frame: 2 years
|
assessed by MacNew Health-related quality of life questionnaire
|
2 years
|
depression
Time Frame: 2 years
|
assessed by Hospital anxiety and depression scale (HAD)
|
2 years
|
Collaborators and Investigators
Investigators
- Principal Investigator: Asbjørn Støylen, prof, Norwegian University of Science and Technology
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2014/92
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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