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Exercise Training Adherence After Cardiac Rehabilitation in Coronary Heart Disease Patients

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ClinicalTrials.gov Identifier: NCT01246570
Recruitment Status : Completed
First Posted : November 23, 2010
Last Update Posted : September 25, 2014
Information provided by (Responsible Party):

Study Description
Brief Summary:
It is known that organized cardiac rehabilitation is effective in improving exercise capacity in coronary heart disease patients. Less is known about the long-term results after cardiac rehabilitation. Earlier studies have shown that many patients quit exercising when no longer attending formal rehabilitation. The investigators wish to investigate the effect of a maintenance program after ending a rehabilitation program, and to compare this to usual care. The investigators hypothesis is that the maintenance program will result in higher exercise capacity and more physical activity compared to usual care.

Condition or disease Intervention/treatment
Coronary Disease Behavioral: Exercise training Other: Control

Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 48 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Supported Home-based Exercise Training Versus Usual Care After Cardiac Rehabilitation. A Randomized Controlled Study
Study Start Date : November 2010
Primary Completion Date : April 2013
Study Completion Date : January 2014

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
Experimental: Maintenance program
Patients will attend a "motivational exercise session" once monthly. They will also be tested (exercise test with measurement of peak oxygen uptake) every third months.
Behavioral: Exercise training
The patients will meet for organized exercise training once monthly and also exercise testing every third month.
Active Comparator: Control
Usual care. The patients will receive the usual care provided by the hospital and community health services
Other: Control
The patients will receive the usual care provided by the hospitals and the community health services

Outcome Measures

Primary Outcome Measures :
  1. Peak oxygen uptake [ Time Frame: baseline and 12 months ]
    The change in peak oxygen uptake from baseline to 12 months after baseline. In the intervention group, the peak oxygen uptake will be measured also every 3 months during the intervention period, and this will be reported

Secondary Outcome Measures :
  1. Myocardial infarction [ Time Frame: baseline and 12 months ]
    Diagnosis of myocardial infarction during the intervention period will be recorded

  2. Hospital readmission [ Time Frame: baseline and 12 months ]
    It will be recorded whether the patients is readmitted to hospital during the intervention period

  3. Death [ Time Frame: baseline and 12 months ]
  4. Endothelial function [ Time Frame: baseline and 12 months ]
    Flow mediated dilatation of the brachial artery, measured by ultrasound. Changes in flow-mediated dilatation from baseline to 12 months after baseline will be recorded

  5. Quality of life [ Time Frame: baseline and 12 months ]
    Mac New health related quality of life questionnaire. Changes in quality of life from baseline to 12 months after baseline will be recorded

  6. Blood markers [ Time Frame: baseline and 12 months ]
    Lipoproteins, c-peptide, ferritin, glucose, high sensitive c-reactive protein will be analysed. Also, blood will be stored for later analyses not yet planned. Changes in markers from baseline to 12 months after baseline will be recorded

  7. Physical activity [ Time Frame: baseline and 12 months ]
    Questionnaire and physical activity sensor (armband) will be measured at baseline and after 12 months.

Eligibility Criteria

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Ages Eligible for Study:   35 Years to 80 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • coronary heart disease patients

Exclusion Criteria:

  • unstable angina pectoris
  • hemodynamic significant valve disease (> New York Heart Association class II)
  • pregnancy
  • left ventricular ejection fraction <30%
  • kidney failure (creatinin > 140)
  • uncontrolled hypertension
Contacts and Locations

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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): NCT01246570

Norwegian University of Science and Technology
Trondheim, Norway
Sponsors and Collaborators
Norwegian University of Science and Technology
Principal Investigator: Trine Moholdt, Phd Norwegian University of Science and Technology
More Information

Responsible Party: Norwegian University of Science and Technology
ClinicalTrials.gov Identifier: NCT01246570     History of Changes
Other Study ID Numbers: Adherence
First Posted: November 23, 2010    Key Record Dates
Last Update Posted: September 25, 2014
Last Verified: September 2014

Keywords provided by Norwegian University of Science and Technology:
coronary disease

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