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Exercise Training Adherence After Cardiac Rehabilitation in Coronary Heart Disease Patients

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Norwegian University of Science and Technology
ClinicalTrials.gov Identifier:
NCT01246570
First received: November 16, 2010
Last updated: April 8, 2012
Last verified: April 2012
History of Changes
  Purpose

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 Intervention
Coronary Disease
 Behavioral: Exercise training
Other: Control

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Supported Home-based Exercise Training Versus Usual Care After Cardiac Rehabilitation. A Randomized Controlled Study

Resource links provided by NLM:

U.S. FDA Resources

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

Primary Outcome Measures:
  • Peak oxygen uptake [ Time Frame: baseline and 12 months ] [ Designated as safety issue: No ]
    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:
  • Myocardial infarction [ Time Frame: baseline and 12 months ] [ Designated as safety issue: No ]
    Diagnosis of myocardial infarction during the intervention period will be recorded

  • Hospital readmission [ Time Frame: baseline and 12 months ] [ Designated as safety issue: No ]
    It will be recorded whether the patients is readmitted to hospital during the intervention period

  • Death [ Time Frame: baseline and 12 months ] [ Designated as safety issue: No ]
  • Endothelial function [ Time Frame: baseline and 12 months ] [ Designated as safety issue: No ]
    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

  • Quality of life [ Time Frame: baseline and 12 months ] [ Designated as safety issue: No ]
    Mac New health related quality of life questionnaire. Changes in quality of life from baseline to 12 months after baseline will be recorded

  • Blood markers [ Time Frame: baseline and 12 months ] [ Designated as safety issue: No ]
    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

  • Physical activity [ Time Frame: baseline and 12 months ] [ Designated as safety issue: No ]
    Questionnaire and physical activity sensor (armband) will be measured at baseline and after 12 months.


Enrollment: 48
Study Start Date: November 2010
Estimated Study Completion Date: January 2014
Estimated Primary Completion Date: April 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   35 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01246570

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

No publications provided

Responsible Party: Norwegian University of Science and Technology
ClinicalTrials.gov Identifier: NCT01246570     History of Changes
Other Study ID Numbers: Adherence
Study First Received: November 16, 2010
Last Updated: April 8, 2012
Health Authority: Norway:National Committee for Medical and Health Research Ethics

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

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 16, 2013