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

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ClinicalTrials.gov Identifier: NCT00363922
Recruitment Status : Completed
First Posted : August 15, 2006
Last Update Posted : September 29, 2015
Sponsor:
Collaborator:
Stiftelsen Helse og Rehabilitering
Information provided by (Responsible Party):
Norwegian University of Science and Technology

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).

Condition or disease Intervention/treatment Phase
Coronary Artery Disease Behavioral: Rehabilitation in institution Behavioral: Rehabilitation at home Behavioral: Out-patient rehabilitation at the hospital Phase 2

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 30 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (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
Study Start Date : September 2006
Actual Primary Completion Date : June 2008
Actual Study Completion Date : June 2008

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
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)



Primary Outcome Measures :
  1. Maximal oxygen consumption [ Time Frame: At baseline and after 6 months ]

Secondary Outcome Measures :
  1. Blood analyses (different markers for cardiovascular risk and endothelian function) [ Time Frame: At baseline and after 6 months ]
  2. Endothelian function (flow mediated dilatation) [ Time Frame: At baseline and after 6 months ]
  3. Quality of life (SF36 and MacNew) [ Time Frame: At baseline and after 6 months ]


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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Coronary artery bypass

Exclusion Criteria:

  • Significant lung disease
  • Drug abuse
  • Pregnancy
  • Major physical impairment

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

Publications of Results:
Responsible Party: Norwegian University of Science and Technology
ClinicalTrials.gov Identifier: NCT00363922     History of Changes
Other Study ID Numbers: 4.2006.2070
First Posted: August 15, 2006    Key Record Dates
Last Update Posted: September 29, 2015
Last Verified: September 2015

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