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

Primary Purpose

Cardiovascular Diseases, Myocardial Infarction, Angina (Stable)

Status
Completed
Phase
Not Applicable
Locations
Norway
Study Type
Interventional
Intervention
high-intensity exercise training
web-based follow-up program
usual care
Sponsored by
Norwegian University of Science and Technology
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Cardiovascular Diseases focused on measuring exercise therapy, rehabilitation

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Levanger Hospital
  • St Olavs Hospital

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Active Comparator

Other

Arm Label

high-intensity exercise

web-based follow-up

control

Arm Description

community-based group program: weekly supervised high-intensity exercise training during 8 weeks, followed by group counselling every third month for 12 months

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

control group will receive usual care: information about recommended physical activity and healthy lifestyle

Outcomes

Primary Outcome Measures

change in peak oxygen uptake
measured during exercise on treadmill (MetaMax Cortex/Innocor)

Secondary Outcome Measures

physical activity
assessed by accelerometer SenseWear Armband Pro
quality of life
assessed by MacNew Health-related quality of life questionnaire
depression
assessed by Hospital anxiety and depression scale (HAD)

Full Information

First Posted
August 27, 2014
Last Updated
August 28, 2019
Sponsor
Norwegian University of Science and Technology
Collaborators
St. Olavs Hospital, Helse Nord-Trøndelag HF
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1. Study Identification

Unique Protocol Identification Number
NCT02228603
Brief Title
Exercise as a Life-long Medicine in Patients With Coronary Artery Disease
Official Title
How to Enhance Physical Activity After Cardiac Rehabilitation? A Randomised Controlled Study Comparing Two Follow-up Training Exercise Programs
Study Type
Interventional

2. Study Status

Record Verification Date
August 2019
Overall Recruitment Status
Completed
Study Start Date
August 2014 (Actual)
Primary Completion Date
June 1, 2019 (Actual)
Study Completion Date
June 1, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Norwegian University of Science and Technology
Collaborators
St. Olavs Hospital, Helse Nord-Trøndelag HF

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cardiovascular Diseases, Myocardial Infarction, Angina (Stable)
Keywords
exercise therapy, rehabilitation

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
161 (Actual)

8. Arms, Groups, and Interventions

Arm Title
high-intensity exercise
Arm Type
Experimental
Arm Description
community-based group program: weekly supervised high-intensity exercise training during 8 weeks, followed by group counselling every third month for 12 months
Arm Title
web-based follow-up
Arm Type
Active Comparator
Arm Description
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
Arm Title
control
Arm Type
Other
Arm Description
control group will receive usual care: information about recommended physical activity and healthy lifestyle
Intervention Type
Behavioral
Intervention Name(s)
high-intensity exercise training
Intervention Type
Behavioral
Intervention Name(s)
web-based follow-up program
Intervention Type
Behavioral
Intervention Name(s)
usual care
Primary Outcome Measure Information:
Title
change in peak oxygen uptake
Description
measured during exercise on treadmill (MetaMax Cortex/Innocor)
Time Frame
2 years
Secondary Outcome Measure Information:
Title
physical activity
Description
assessed by accelerometer SenseWear Armband Pro
Time Frame
2 years
Title
quality of life
Description
assessed by MacNew Health-related quality of life questionnaire
Time Frame
2 years
Title
depression
Description
assessed by Hospital anxiety and depression scale (HAD)
Time Frame
2 years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Asbjørn Støylen, prof
Organizational Affiliation
Norwegian University of Science and Technology
Official's Role
Principal Investigator
Facility Information:
Facility Name
Levanger Hospital
City
Levanger
Country
Norway
Facility Name
St Olavs Hospital
City
Trondheim
Country
Norway

12. IPD Sharing Statement

Learn more about this trial

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

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