Rehabilitation After Coronary Bypass Grafting. Comparison of Different Types of Rehabilitation Programs

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to compare different types of rehabilitation after coronary bypass surgery. The investigators wish to compare rehabilitation in an institution for four weeks with a home based rehabilitation. They also wish to compare rehabilitation in an institution for four weeks with a rehabilitation program were the patients live at home but visit the hospital twice a week for twelve week. The investigators will measure the patients' physical capacity by measuring their maximal oxygen consumption. The investigators will also analyze their blood and their endothelian function (how well their arteries dilate).

Official Title
-----------------
Rehabilitation After Coronary Bypass Grafting: Home Based Rehabilitation Versus Rehabilitation in Institution and Rehabilitation in Institution Versus Out-patient Rehabilitation at the Hospital

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

Intervention / Treatment
-----------------
* Behavioral: Rehabilitation in institution
* Behavioral: Rehabilitation at home
* Behavioral: Out-patient rehabilitation at the hospital


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Coronary artery bypass Exclusion Criteria: Significant lung disease Drug abuse Pregnancy Major physical impairment

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

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

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

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: 1<br>Rehabilitation in institution | Behavioral: Rehabilitation in institution<br>* Rehabilitation in institution for four weeks. Subjects follow standard rehabilitation in the center.<br>|
| Active Comparator: 2<br>Rehabilitation at home | Behavioral: Rehabilitation at home<br>* Subjects get a written prescription of exercise training, diet, etc. to follow at home.<br>Behavioral: Out-patient rehabilitation at the hospital<br>* This intervention was removed. We never got time to randomize subjects into this category. We had planned to randomize patients from one hospital to either Rehabilitation in institution (rehab center) or rehabilitation at the hospital (out patient). And also patients from another hospital to either rehabilitation in institution (rehab centre) or rehabilitation at home. We have only managed to start the study in this second hospital so far (due to maternity leave and limited time to finish a PhD)<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Maximal oxygen consumption |  | At baseline and after 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Blood analyses (different markers for cardiovascular risk and endothelian function) |  | At baseline and after 6 months | 
| Endothelian function (flow mediated dilatation) |  | At baseline and after 6 months | 
| Quality of life (SF36 and MacNew) |  | At baseline and after 6 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Coronary Artery Bypass [E04.100.376.719.332]