Exercise Training Adherence After Cardiac Rehabilitation in Coronary Heart Disease Patients

September 24, 2014 updated by: Norwegian University of Science and Technology

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

48

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
      • Trondheim, Norway
        • Norwegian University of Science and Technology

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

35 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

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: 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.
Behavioral: Exercise training
The patients will meet for organized exercise training once monthly and also exercise testing every third month.
Active Comparator: Control
Usual care. The patients will receive the usual care provided by the hospital and community health services
Other: Control
The patients will receive the usual care provided by the hospitals and the community health services

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
baseline and 12 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Myocardial infarction
Time Frame: baseline and 12 months
Diagnosis of myocardial infarction during the intervention period will be recorded
baseline and 12 months
Hospital readmission
Time Frame: baseline and 12 months
It will be recorded whether the patients is readmitted to hospital during the intervention period
baseline and 12 months
Death
Time Frame: baseline and 12 months
baseline and 12 months
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
baseline and 12 months
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
baseline and 12 months
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
baseline and 12 months
Physical activity
Time Frame: baseline and 12 months
Questionnaire and physical activity sensor (armband) will be measured at baseline and after 12 months.
baseline and 12 months

Collaborators and Investigators

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

Sponsor

Norwegian University of Science and Technology

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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

November 1, 2010

Primary Completion (Actual)

April 1, 2013

Study Completion (Actual)

January 1, 2014

Study Registration Dates

First Submitted

November 16, 2010

First Submitted That Met QC Criteria

November 22, 2010

First Posted (Estimate)

November 23, 2010

Study Record Updates

Last Update Posted (Estimate)

September 25, 2014

Last Update Submitted That Met QC Criteria

September 24, 2014

Last Verified

September 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Adherence

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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