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Exercise as a Life-long Medicine in Patients With Coronary Artery Disease

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02228603
Recruitment Status : Completed
First Posted : August 29, 2014
Last Update Posted : August 30, 2019
Sponsor:
Collaborators:
St. Olavs Hospital
Levanger Hospital
Information provided by (Responsible Party):
Norwegian University of Science and Technology

Brief Summary:

Exercise training is a core component in cardiac rehabilitation. Exercise adherence is, however, low after rehabilitation and the transition from supervised to unsupervised exercise is problematic for many patients with coronary artery disease. Therefore, it is important to provide extended services to improve exercise adherence and healthy lifestyle changes.

The aim of this study is to assess the effect of a time-limited intervention following out-patient cardiac rehabilitation on exercise adherence and cardiovascular risk reduction.


Condition or disease Intervention/treatment Phase
Cardiovascular Diseases Myocardial Infarction Angina (Stable) Behavioral: high-intensity exercise training Behavioral: web-based follow-up program Behavioral: usual care Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 161 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: How to Enhance Physical Activity After Cardiac Rehabilitation? A Randomised Controlled Study Comparing Two Follow-up Training Exercise Programs
Actual Study Start Date : August 2014
Actual Primary Completion Date : June 1, 2019
Actual Study Completion Date : June 1, 2019

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: high-intensity exercise
community-based group program: weekly supervised high-intensity exercise training during 8 weeks, followed by group counselling every third month for 12 months
Behavioral: high-intensity exercise training
Active Comparator: web-based follow-up
web-based follow-up program: home-based group will be followed up by mail and telephone calls the first 8 weeks, then every third month for 12 months
Behavioral: web-based follow-up program
control
control group will receive usual care: information about recommended physical activity and healthy lifestyle
Behavioral: usual care



Primary Outcome Measures :
  1. change in peak oxygen uptake [ Time Frame: 2 years ]
    measured during exercise on treadmill (MetaMax Cortex/Innocor)


Secondary Outcome Measures :
  1. physical activity [ Time Frame: 2 years ]
    assessed by accelerometer SenseWear Armband Pro

  2. quality of life [ Time Frame: 2 years ]
    assessed by MacNew Health-related quality of life questionnaire

  3. depression [ Time Frame: 2 years ]
    assessed by Hospital anxiety and depression scale (HAD)



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • myocardial infarction, stable angina, heart surgery
  • finished phase 2 cardiac rehabilitation
  • clinically stable
  • able to communicate in Norwegian
  • able to do a maximal treadmill test

Exclusion Criteria:

  • unstable angina
  • serious cardiac arrhythmia
  • serious heart valve insufficiency
  • heart failure
  • any contraindication for high intensity exercise training
  • participation in other exercise study
  • pregnancy
  • cognitive impairment
  • drug abuse

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): NCT02228603


Locations
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Norway
Levanger Hospital
Levanger, Norway
St Olavs Hospital
Trondheim, Norway
Sponsors and Collaborators
Norwegian University of Science and Technology
St. Olavs Hospital
Levanger Hospital
Investigators
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Principal Investigator: Asbjørn Støylen, prof Norwegian University of Science and Technology

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Responsible Party: Norwegian University of Science and Technology
ClinicalTrials.gov Identifier: NCT02228603     History of Changes
Other Study ID Numbers: 2014/92
First Posted: August 29, 2014    Key Record Dates
Last Update Posted: August 30, 2019
Last Verified: August 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Norwegian University of Science and Technology:
exercise therapy
rehabilitation
Additional relevant MeSH terms:
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Myocardial Infarction
Infarction
Cardiovascular Diseases
Ischemia
Pathologic Processes
Necrosis
Myocardial Ischemia
Heart Diseases
Vascular Diseases