Exercise Training Adherence After Cardiac Rehabilitation in Coronary Heart Disease Patients

Study Overview
=================
Brief Summary
-----------------
It is known that organized cardiac rehabilitation is effective in improving exercise capacity in coronary heart disease patients. Less is known about the long-term results after cardiac rehabilitation. Earlier studies have shown that many patients quit exercising when no longer attending formal rehabilitation. The investigators wish to investigate the effect of a maintenance program after ending a rehabilitation program, and to compare this to usual care. The investigators hypothesis is that the maintenance program will result in higher exercise capacity and more physical activity compared to usual care.

Official Title
-----------------
Supported Home-based Exercise Training Versus Usual Care After Cardiac Rehabilitation. A Randomized Controlled Study

Conditions
-----------------
Coronary Disease

Intervention / Treatment
-----------------
* Behavioral: Exercise training
* Other: Control


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: coronary heart disease patients Exclusion Criteria: unstable angina pectoris hemodynamic significant valve disease (> New York Heart Association class II) pregnancy left ventricular ejection fraction <30% kidney failure (creatinin > 140) uncontrolled hypertension

Ages Eligible for Study
-----------------
Minimum Age: 35 Years
Maximum Age: 80 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Maintenance program<br>Patients will attend a motivational exercise session once monthly. They will also be tested (exercise test with measurement of peak oxygen uptake) every third months. | Behavioral: Exercise training<br>* The patients will meet for organized exercise training once monthly and also exercise testing every third month.<br>|
| Active Comparator: Control<br>Usual care. The patients will receive the usual care provided by the hospital and community health services | Other: Control<br>* The patients will receive the usual care provided by the hospitals and the community health services<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Peak oxygen uptake | The change in peak oxygen uptake from baseline to 12 months after baseline. In the intervention group, the peak oxygen uptake will be measured also every 3 months during the intervention period, and this will be reported | baseline and 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Myocardial infarction | Diagnosis of myocardial infarction during the intervention period will be recorded | baseline and 12 months | 
| Hospital readmission | It will be recorded whether the patients is readmitted to hospital during the intervention period | baseline and 12 months | 
| Death |  | baseline and 12 months | 
| Endothelial function | Flow mediated dilatation of the brachial artery, measured by ultrasound. Changes in flow-mediated dilatation from baseline to 12 months after baseline will be recorded | baseline and 12 months | 
| Quality of life | Mac New health related quality of life questionnaire. Changes in quality of life from baseline to 12 months after baseline will be recorded | baseline and 12 months | 
| Blood markers | Lipoproteins, c-peptide, ferritin, glucose, high sensitive c-reactive protein will be analysed. Also, blood will be stored for later analyses not yet planned. Changes in markers from baseline to 12 months after baseline will be recorded | baseline and 12 months | 
| Physical activity | Questionnaire and physical activity sensor (armband) will be measured at baseline and after 12 months. | baseline and 12 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
exercise, heart, coronary disease, rehabilitation