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OpenTrials
Completed

NCT Number: NCT01246570

Exercise Training Adherence After Cardiac Rehabilitation in Coronary Heart Disease Patients

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.

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Key information

Conditions

Coronary Disease Behavior Cardiovascular Diseases Heart Diseases Motor Activity Myocardial Ischemia Vascular Diseases

Age range

35 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Norwegian University of Science and Technology

Trondheim, Norway

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Exercise Training

Behavioral

The patients will meet for organized exercise training once monthly and also exercise testing every third month.

Control

Other

The patients will receive the usual care provided by the hospitals and the community health services

Primary outcomes

  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 outcomes

  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.

Sponsors and collaborators

Lead sponsor

Norwegian University of Science and Technology

Other

Registry information

Official study title

Supported Home-based Exercise Training Versus Usual Care After Cardiac Rehabilitation. A Randomized Controlled Study

Important dates

Study start
2010
Primary completion
2013
Study completion
2014
First posted
Nov 23, 2010
Registry last updated
Sep 25, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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