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Influence of Training Intensity in Coronary Artery Disease

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ClinicalTrials.gov Identifier: NCT03034980
Recruitment Status : Completed
First Posted : January 27, 2017
Last Update Posted : February 27, 2018
Sponsor:
Collaborator:
Jessa Hospital
Information provided by (Responsible Party):
prof. dr. Paul Dendale, Hasselt University

Brief Summary:

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.


Condition or disease Intervention/treatment
Coronary Artery Disease Other: Training intensity (workload) during ergospirometry

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Study Type : Observational
Estimated Enrollment : 343 participants
Observational Model: Case-Control
Time Perspective: Retrospective
Official Title: Influence of Training Intensity on Exercise Capacity and Risk Profile in Coronary Artery Disease
Actual Study Start Date : December 20, 2016
Actual Primary Completion Date : July 1, 2017
Actual Study Completion Date : September 15, 2017

Resource links provided by the National Library of Medicine


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.




Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. cardiovascular risk profile [ Time Frame: up to week 12 ]
    The secondary endpoint is the relationship between relative training load and the cardiovascular risk factors.



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Ages Eligible for Study:   25 Years to 90 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
Criteria

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.

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): NCT03034980


Locations
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Belgium
Jessa Ziekenhuis
Hasselt, Belgium, 3500
Sponsors and Collaborators
Hasselt University
Jessa Hospital
Investigators
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Principal Investigator: Kaatje Goetschalckx, MD Catholic University Leuven, Belgium

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Responsible Party: prof. dr. Paul Dendale, prof. dr., Hasselt University
ClinicalTrials.gov Identifier: NCT03034980     History of Changes
Other Study ID Numbers: PD-VG-01
First Posted: January 27, 2017    Key Record Dates
Last Update Posted: February 27, 2018
Last Verified: February 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
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Coronary Artery Disease
Myocardial Ischemia
Coronary Disease
Heart Diseases
Cardiovascular Diseases
Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases