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

August 28, 2019 updated by: Norwegian University of Science and Technology

How to Enhance Physical Activity After Cardiac Rehabilitation? A Randomised Controlled Study Comparing Two Follow-up Training Exercise Programs

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

161

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Norway
      • Levanger, Norway
        • Levanger hospital
      • Trondheim, Norway
        • St Olavs Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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
Other: control
control group will receive usual care: information about recommended physical activity and healthy lifestyle
Behavioral: usual care

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
change in peak oxygen uptake
Time Frame: 2 years
measured during exercise on treadmill (MetaMax Cortex/Innocor)
2 years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
physical activity
Time Frame: 2 years
assessed by accelerometer SenseWear Armband Pro
2 years
quality of life
Time Frame: 2 years
assessed by MacNew Health-related quality of life questionnaire
2 years
depression
Time Frame: 2 years
assessed by Hospital anxiety and depression scale (HAD)
2 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Norwegian University of Science and Technology

Collaborators

St. Olavs Hospital
Helse Nord-Trøndelag HF

Investigators

  • Principal Investigator: Asbjørn Støylen, prof, Norwegian University of Science and Technology

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 1, 2014

Primary Completion (Actual)

June 1, 2019

Study Completion (Actual)

June 1, 2019

Study Registration Dates

First Submitted

August 27, 2014

First Submitted That Met QC Criteria

August 27, 2014

First Posted (Estimate)

August 29, 2014

Study Record Updates

Last Update Posted (Actual)

August 30, 2019

Last Update Submitted That Met QC Criteria

August 28, 2019

Last Verified

August 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2014/92

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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