Influence of Training Intensity in Coronary Artery Disease

February 26, 2018 updated by: prof. dr. Paul Dendale, Hasselt University

Influence of Training Intensity on Exercise Capacity and Risk Profile in Coronary Artery Disease

Coronary artery disease (CAD) is associated with high mortality worldwide. Narrowing of the coronary arteries can cause an acute myocardial infarction. Patient with cardiac ischemia are often treated with percutaneous coronary intervention (PCI) or coronary artery bypass grafting (CABG). Following hospitalisation, the patients are offered to attend a classical rehabilitation program with moderate exercise intensity. Current exercise program for cardiac rehabilitation has proven to reduce cardiovascular risk factors 1. Is it possible to improve the exercise capacity and risk profile even more if the exercise program includes more vigorous training? The program starts one week after the cardiac incident (AMI, PCI or CABG) and takes 12 weeks to complete. Patients with heart failure and valvular disease are excluded. First ventilatory threshold (VT1) and second ventilatory threshold (VT2) are determined during cycloerometry. VT2 reflects aerobic-anaerobic transition and therefore the aerobic functional capacity2. Exercise load reached at VT2 is used to determine the training load during rehabilitation.

The research goal is to investigate the influence of training intensity on the exercise capacity and risk profile of CAD patients.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Anticipated)

343

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

  • Belgium
      • Hasselt, Belgium, 3500
        • Jessa Ziekenhuis

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

25 years to 90 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

Patients with proven coronary artery disease, who underwent the full cardiac revalidation program at Jessa Hospital from 10-1-2013 till 12-9-2016.

Description

Inclusion Criteria:

  • Patients with acute myocardial infarction (AMI), who underwent a percutaneous coronary intervention (PCI) or coronary artery bypass grafting (CABG). The 12-week program must be completed.

Exclusion Criteria:

  • Patients with heart failure (HFpEF and HFrEF with ejection fraction ≤40%) and valvular heart disease.

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

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Coronary Artery Disease (CAD) patients
Patients with proven coronary artery disease, who underwent the full cardiac revalidation program at Jessa Hospital from 10-1-2013 till 12-9-2016.
Other: Training intensity (workload) during ergospirometry
The reached workload (W) during each training is noted during 12 weeks of rehabilitation. The relative intensity is expressed as a percentage of VT1 and VT2.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
exercise capacity
Time Frame: up to week 12
The primary endpoint is the relationship between the actual training load (W) and exercise capacity (VO2max) obtained at the end of the rehabilitation.
up to week 12

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
cardiovascular risk profile
Time Frame: up to week 12
The secondary endpoint is the relationship between relative training load and the cardiovascular risk factors.
up to week 12

Collaborators and Investigators

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

Sponsor

Hasselt University

Collaborators

Jessa Hospital

Investigators

  • Principal Investigator: Kaatje Goetschalckx, MD, Catholic University Leuven, Belgium

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)

December 20, 2016

Primary Completion (Actual)

July 1, 2017

Study Completion (Actual)

September 15, 2017

Study Registration Dates

First Submitted

January 25, 2017

First Submitted That Met QC Criteria

January 25, 2017

First Posted (Estimate)

January 27, 2017

Study Record Updates

Last Update Posted (Actual)

February 27, 2018

Last Update Submitted That Met QC Criteria

February 26, 2018

Last Verified

February 1, 2018

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PD-VG-01

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

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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