Exercise Training Adherence After Cardiac Rehabilitation in Coronary Heart Disease Patients

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Norwegian University of Science and Technology
ClinicalTrials.gov Identifier:
NCT01246570
First received: November 16, 2010
Last updated: February 26, 2014
Last verified: February 2014

November 16, 2010
February 26, 2014
November 2010
April 2013   (final data collection date for primary outcome measure)
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
Change in peak oxygen uptake [ Time Frame: 12 months after baseline ] [ Designated as safety issue: No ]
In the patients allocated to the maintenance program, peak oxygen uptake will also be measured every 3rd month
Complete list of historical versions of study NCT01246570 on ClinicalTrials.gov Archive Site
  • 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.
  • Myocardial infarction [ Time Frame: 12 months after baseline ] [ Designated as safety issue: No ]
    Diagnosis of myocardial infarction during the intervention period will be recorded
  • Hospital readmission [ Time Frame: 12 months after baseline ] [ Designated as safety issue: No ]
    It will be recorded whether the patients is readmitted to hospital during the intervention period
  • Death [ Time Frame: 12 months after baseline ] [ Designated as safety issue: No ]
  • Change in endothelial function [ Time Frame: 12 months after baseline ] [ Designated as safety issue: No ]
    Flow mediated dilatation of the brachial artery, measured by ultrasound
  • Change in quality of life [ Time Frame: 12 months after baseline ] [ Designated as safety issue: No ]
    Mac New health related quality of life questionnaire
  • Changes in blood markers [ Time Frame: 12 months after baseline ] [ Designated as safety issue: No ]
    Lipoproteins, c-peptide, ferritin, glucose, hs-CRP will be analysed. Also, blood will be stored for later analyses not yet planned.
  • Change in physical activity [ Time Frame: 12 months after baseline ] [ Designated as safety issue: No ]
    Questionnaire and physical activity sensor (armband)
Not Provided
Not Provided
 
Exercise Training Adherence After Cardiac Rehabilitation in Coronary Heart Disease Patients
Supported Home-based Exercise Training Versus Usual Care After Cardiac Rehabilitation. A Randomized Controlled Study

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.

Not Provided
Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Coronary Disease
  • Behavioral: Exercise training
    The patients will meet for organized exercise training once monthly and also exercise testing every third month.
  • Other: Control
    The patients will receive the usual care provided by the hospitals and the community health services
  • 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.
    Intervention: Behavioral: Exercise training
  • Active Comparator: Control
    Usual care. The patients will receive the usual care provided by the hospital and community health services
    Intervention: Other: Control
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
48
January 2014
April 2013   (final data collection date for primary outcome measure)

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
Both
35 Years to 80 Years
No
Contact information is only displayed when the study is recruiting subjects
Norway
 
NCT01246570
Adherence
No
Norwegian University of Science and Technology
Norwegian University of Science and Technology
Not Provided
Principal Investigator: Trine Moholdt, Phd Norwegian University of Science and Technology
Norwegian University of Science and Technology
February 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP