Rehabilitation After Coronary Bypass Grafting. Comparison of Different Types of Rehabilitation Programs - Full Text View

Sponsors and Collaborators:	Norwegian University of Science and Technology Stiftelsen Helse og Rehabilitering
Information provided by:	Norwegian University of Science and Technology
ClinicalTrials.gov Identifier:	NCT00363922

Purpose

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).

Condition	Intervention	Phase
Coronary Artery Disease	Behavioral: Rehabilitation in institution Behavioral: Rehabilitation at home Behavioral: Out-patient rehabilitation at the hospital	Phase II

Study Type:	Interventional
Study Design:	Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Efficacy Study
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

Resource links provided by NLM:

MedlinePlus related topics: Coronary Artery Bypass Surgery Coronary Artery Disease Health Facilities Rehabilitation

U.S. FDA Resources

Further study details as provided by Norwegian University of Science and Technology:

Primary Outcome Measures:

Maximal oxygen consumption [ Time Frame: At baseline and after 6 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Blood analyses (different markers for cardiovascular risk and endothelian function) [ Time Frame: At baseline and after 6 months ] [ Designated as safety issue: No ]
Endothelian function (flow mediated dilatation) [ Time Frame: At baseline and after 6 months ] [ Designated as safety issue: No ]
Quality of life (SF36 and MacNew) [ Time Frame: At baseline and after 6 months ] [ Designated as safety issue: No ]

Estimated Enrollment:	40
Study Start Date:	September 2006
Study Completion Date:	June 2008
Primary Completion Date:	June 2008 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Experimental Rehabilitation in institution	Behavioral: Rehabilitation in institution Rehabilitation in institution for four weeks. Subjects follow standard rehabilitation in the center.
2: Active Comparator Rehabilitation at home	Behavioral: Rehabilitation at home Subjects get a written prescription of exercise training, diet, etc. to follow at home. Behavioral: 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)

Arms

Assigned Interventions

1: Experimental

Rehabilitation in institution

Behavioral: Rehabilitation in institution

Rehabilitation in institution for four weeks. Subjects follow standard rehabilitation in the center.

2: Active Comparator

Rehabilitation at home

Behavioral: Rehabilitation at home

Subjects get a written prescription of exercise training, diet, etc. to follow at home.

Behavioral: 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)

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	Yes

Criteria

Inclusion Criteria:

Coronary artery bypass

Exclusion Criteria:

Significant lung disease
Drug abuse
Pregnancy
Major physical impairment

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00363922

Locations

Norway
Norwegian University of Science and Technology
Trondheim, Norway, 7489

Sponsors and Collaborators

Norwegian University of Science and Technology

Stiftelsen Helse og Rehabilitering

Investigators

Principal Investigator:

Trine T. Moholdt, cand.polit

NTNU

More Information

No publications provided

Responsible Party:	NTNU ( Trine Moholdt )
Study ID Numbers:	4.2006.2070
Study First Received:	August 10, 2006
Last Updated:	November 18, 2008
ClinicalTrials.gov Identifier:	NCT00363922 History of Changes
Health Authority:	Norway: The National Committees for Research Ethics in Norway

Keywords provided by Norwegian University of Science and Technology:

Coronary Artery Bypass [E04.100.376.719.332]

Study placed in the following topic categories:

Arterial Occlusive Diseases
Coronary Disease
Heart Diseases
Myocardial Ischemia

Vascular Diseases
Arteriosclerosis
Ischemia
Coronary Artery Disease

Additional relevant MeSH terms:

Arterial Occlusive Diseases
Coronary Disease
Heart Diseases
Myocardial Ischemia

Vascular Diseases
Cardiovascular Diseases
Arteriosclerosis
Coronary Artery Disease

ClinicalTrials.gov processed this record on September 02, 2009