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

This study has been completed.
Sponsor:
Collaborator:
Stiftelsen Helse og Rehabilitering
Information provided by (Responsible Party):
Norwegian University of Science and Technology
ClinicalTrials.gov Identifier:
NCT00363922
First received: August 10, 2006
Last updated: July 23, 2012
Last verified: July 2012
History of Changes
  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 2

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

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 ]

Enrollment: 30
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
Experimental: 1
Rehabilitation in institution
 Behavioral: Rehabilitation in institution
Rehabilitation in institution for four weeks. Subjects follow standard rehabilitation in the center.
Active Comparator: 2
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

Publications:

Responsible Party: Norwegian University of Science and Technology
ClinicalTrials.gov Identifier: NCT00363922     History of Changes
Other Study ID Numbers: 4.2006.2070
Study First Received: August 10, 2006
Last Updated: July 23, 2012
Health Authority: Norway:National Committee for Medical and Health Research Ethics

Keywords provided by Norwegian University of Science and Technology:
Coronary Artery Bypass [E04.100.376.719.332]

Additional relevant MeSH terms:
Coronary Artery Disease
Myocardial Ischemia
Coronary Disease
Heart Diseases
 Cardiovascular Diseases
Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases

ClinicalTrials.gov processed this record on May 21, 2013