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

Coronary Artery Disease Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00363922
• Other study ID #: 4.2006.2070
• Status: Completed
• Phase: Phase 2
• First received: August 10, 2006
• Last updated: September 28, 2015
• Start date: September 2006
• Est. completion date: June 2008

Study information

• Verified date: September 2015
• Source: Norwegian University of Science and Technology
• Contact: n/a
• Is FDA regulated: No
• Health authority: Norway:National Committee for Medical and Health Research Ethics
• Study type: Interventional

Clinical Trial 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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: June 2008
• Est. primary completion date: June 2008
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Coronary artery bypass

Exclusion Criteria:

• Significant lung disease

• Drug abuse

• Pregnancy

• Major physical impairment

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Coronary Artery Disease
• Coronary Disease
• Myocardial Ischemia

Intervention

Behavioral:
• Rehabilitation in institution
Rehabilitation in institution for four weeks. Subjects follow standard rehabilitation in the center.
• Rehabilitation at home
Subjects get a written prescription of exercise training, diet, etc. to follow at home.
• Out-patient rehabilitation at the hospital
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)

Locations

Country	Name	City	State
Norway	Norwegian University of Science and Technology	Trondheim

Sponsors (2)

Lead Sponsor	Collaborator
Norwegian University of Science and Technology	Stiftelsen Helse og Rehabilitering

Country where clinical trial is conducted

Norway, 

References & Publications (1)

Moholdt T, Bekken Vold M, Grimsmo J, Slørdahl SA, Wisløff 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.pon — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Maximal oxygen consumption		At baseline and after 6 months	No
Secondary	Blood analyses (different markers for cardiovascular risk and endothelian function)		At baseline and after 6 months	No
Secondary	Endothelian function (flow mediated dilatation)		At baseline and after 6 months	No
Secondary	Quality of life (SF36 and MacNew)		At baseline and after 6 months	No