Influence of Training Intensity in Coronary Artery Disease

NCT03034980 | Completed

• 1 other identifier: PD-VG-01
• Study Type: observational
• Target: 343
• Locations: 1 country
• Sites: 1

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.

Conditions

Coronary Artery Disease

Outcome Measures

Primary Outcomes (1)

• exercise capacity

  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 Outcomes (1)

• cardiovascular risk profile

  up to week 12

Study Arms (1)

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

Interventions

Training intensity (workload) during ergospirometry OTHER

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.

Coronary Artery Disease (CAD) patients

Eligibility Criteria

• Age: 25 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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.

You may not qualify if:

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

Sponsors & Collaborators

• Hasselt University: lead
• Jessa Hospital: collaborator

Study Sites (1)

Jessa Ziekenhuis

Hasselt, 3500, Belgium

Location

MeSH Terms

Conditions

Coronary Artery Disease

Interventions

Workload

Condition Hierarchy (Ancestors)

Coronary Disease; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases

Intervention Hierarchy (Ancestors)

Personnel Staffing and Scheduling; Personnel Management; Organization and Administration; Health Services Administration

Study Officials

• Kaatje Goetschalckx, MD

  Catholic University Leuven, Belgium

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: prof. dr.

Study Record Dates

• First Submitted: January 25, 2017
• First Posted: January 27, 2017
• Study Start: December 20, 2016
• Primary Completion: July 1, 2017
• Study Completion: September 15, 2017
• Last Updated: February 27, 2018

Record last verified: 2018-02

Data Sharing

• IPD Sharing: Will not share

Locations

BE (1)