Back to resultsRehabilitation After Coronary Bypass Grafting. Comparison of Different Types of Rehabilitation Programs
Primary Purpose
Coronary Artery Disease
Status
Completed
Phase
Phase 2
Locations
Norway
Study Type
Interventional
Intervention
Rehabilitation in institution
Rehabilitation at home
Out-patient rehabilitation at the hospital
Sponsored by
About this trial
This is an interventional treatment trial for Coronary Artery Disease focused on measuring Coronary Artery Bypass [E04.100.376.719.332]
Eligibility Criteria
Inclusion Criteria: Coronary artery bypass Exclusion Criteria: Significant lung disease Drug abuse Pregnancy Major physical impairment
Sites / Locations
- Norwegian University of Science and Technology
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
1
2
Arm Description
Rehabilitation in institution
Rehabilitation at home
Outcomes
Primary Outcome Measures
Maximal oxygen consumption
Secondary Outcome Measures
Blood analyses (different markers for cardiovascular risk and endothelian function)
Endothelian function (flow mediated dilatation)
Quality of life (SF36 and MacNew)
Full Information
NCT ID
NCT00363922
First Posted
August 10, 2006
Last Updated
September 28, 2015
Sponsor
Norwegian University of Science and Technology
Collaborators
Stiftelsen Helse og Rehabilitering
1. Study Identification
Unique Protocol Identification Number
NCT00363922
Brief Title
Rehabilitation After Coronary Bypass Grafting. Comparison of Different Types of Rehabilitation Programs
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
Study Type
Interventional
2. Study Status
Record Verification Date
September 2015
Overall Recruitment Status
Completed
Study Start Date
September 2006 (undefined)
Primary Completion Date
June 2008 (Actual)
Study Completion Date
June 2008 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Norwegian University of Science and Technology
Collaborators
Stiftelsen Helse og Rehabilitering
4. Oversight
Data Monitoring Committee
No
5. Study Description
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).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Coronary Artery Disease
Keywords
Coronary Artery Bypass [E04.100.376.719.332]
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
30 (Actual)
8. Arms, Groups, and Interventions
Arm Title
1
Arm Type
Experimental
Arm Description
Rehabilitation in institution
Arm Title
2
Arm Type
Active Comparator
Arm Description
Rehabilitation at home
Intervention Type
Behavioral
Intervention Name(s)
Rehabilitation in institution
Intervention Description
Rehabilitation in institution for four weeks. Subjects follow standard rehabilitation in the center.
Intervention Type
Behavioral
Intervention Name(s)
Rehabilitation at home
Intervention Description
Subjects get a written prescription of exercise training, diet, etc. to follow at home.
Intervention Type
Behavioral
Intervention Name(s)
Out-patient rehabilitation at the hospital
Intervention Description
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)
Primary Outcome Measure Information:
Title
Maximal oxygen consumption
Time Frame
At baseline and after 6 months
Secondary Outcome Measure Information:
Title
Blood analyses (different markers for cardiovascular risk and endothelian function)
Time Frame
At baseline and after 6 months
Title
Endothelian function (flow mediated dilatation)
Time Frame
At baseline and after 6 months
Title
Quality of life (SF36 and MacNew)
Time Frame
At baseline and after 6 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Coronary artery bypass
Exclusion Criteria:
Significant lung disease
Drug abuse
Pregnancy
Major physical impairment
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Trine T. Moholdt, cand.polit
Organizational Affiliation
National Taiwan Normal University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Norwegian University of Science and Technology
City
Trondheim
ZIP/Postal Code
7489
Country
Norway
12. IPD Sharing Statement
Citations:
PubMed Identifier
22815970
Citation
Moholdt T, Bekken Vold M, Grimsmo J, Slordahl SA, Wisloff U. Home-based aerobic interval training improves peak oxygen uptake equal to residential cardiac rehabilitation: a randomized, controlled trial. PLoS One. 2012;7(7):e41199. doi: 10.1371/journal.pone.0041199. Epub 2012 Jul 18.
Results Reference
result
Learn more about this trial
Rehabilitation After Coronary Bypass Grafting. Comparison of Different Types of Rehabilitation Programs
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