A Multicentre Trial on the Effectiveness of Physical Rehabilitation of Patients With Coronary Artery Disease: Aerobic Interval Training Versus Moderate Continuous Training.

NCT ID: NCT01226225

Last Updated: 2010-11-10

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE3
• Total Enrollment: 200 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2010-11-30
• Study Completion Date: 2013-09-30

Brief Summary

Cardiac rehabilitation, including physical training, has become accepted treatment following myocardial infarction, coronary stent implantation and coronary bypass operation. Besides modifying patients' risk profile for future coronary problems, the focus is on improving exercise capacity. The ability to be able to perform at a higher maximal level is a strong predictor for outcome (new cardiovascular events and mortality). The main purpose of this study is to evaluate whether aerobic interval training outweighs more classical moderate endurance training in improving exercise capacity. During interval training, patients perform exercise at high intensity, but for only a couple of minutes and then recover at a lower intensity. Such intervals are repeated. Preliminary evidence from smaller studies suggests that this type of training leads to a larger increase in exercise capacity, compared to the more traditional endurance training at moderate intensity.

In addition, mechanisms that might explain how this improvement is achieved, as well as safety and impact on quality of life will be studied.

Conditions

Coronary Artery Disease (CAD); Myocardial Infarction (MI); Percutaneous Coronary Intervention (PCI); Coronary Artery Bypass Grafting (CABG)

Keywords

Patients with recent coronary event

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Aerobic interval training

Group Type: EXPERIMENTAL

Aerobic interval training

Intervention Type: BEHAVIORAL

Patients will enter a training program during which aerobic interval training is implemented. Three sessions per week, each lasting for 60 minutes. Total duration of the program: 3 months.

Moderate endurance training

Group Type: ACTIVE_COMPARATOR

Moderate endurance training

Intervention Type: BEHAVIORAL

Patients will enter a training program during which moderate endurance training is implemented. Three sessions per week, each lasting for 60 minutes. Total duration of the program: 3 months.

Interventions

Aerobic interval training

Patients will enter a training program during which aerobic interval training is implemented. Three sessions per week, each lasting for 60 minutes. Total duration of the program: 3 months.

Intervention Type: BEHAVIORAL

Moderate endurance training

Patients will enter a training program during which moderate endurance training is implemented. Three sessions per week, each lasting for 60 minutes. Total duration of the program: 3 months.

Intervention Type: BEHAVIORAL

Eligibility Criteria

Inclusion Criteria

• patients with CAD (post-PCI, post-MI, post-CABG) and a left ventricular ejection fraction (LVEF) > 40%
• the presence of CAD is defined as prior angiographically documented stenotic lesion(s) of > 75%, or documented myocardial infarction (biochemical, ECG, echocardiographic documentation).
• patients are on optimal medical treatment and stable with regard to symptoms and pharmacotherapy for at least 4 weeks
• in practice, patients will have been hospitalized at least 4 weeks prior to participation in the training programme because of PCI, MI or CABG

Exclusion Criteria

• significant intercurrent illness last 6 weeks
• known severe ventricular arrhythmia with functional or prognostic significance
• significant myocardial ischemia, hemodynamic deterioration or exercise-induced arrhythmia at baseline testing
• recent CABG (< 30 days)
• other heart disease that limits exercise tolerance (valve disease with significant hemodynamic consequences, hypertrophic cardiomyopathy etc.)
• co-morbidity that may significantly influence one-year prognosis
• functional or mental disability that may limit exercise
• a habit of regular vigorous exercise or participation in a programme of exercise training less than 3 months before inclusion
• acute or chronic inflammatory diseases or malignancy, the use of anti-inflammatory drugs or immune suppression
• glomerular filtration rate (GFR) <25ml/min/1.73m2
• hemoglobin < 10g/dl
• severe chronic obstructive pulmonary disease
• participation in another clinical trial

• Minimum Eligible Age: 40 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

KU Leuven

OTHER

Sponsor Role: collaborator

Universitaire Ziekenhuizen KU Leuven

OTHER

Sponsor Role: collaborator

University Hospital, Antwerp

OTHER

Sponsor Role: lead

Responsible Party

Antwerp University Hospital, Belgium

Locations

Dienst Cardiale Revalidatie, Cardiologie, Universitair Ziekenhuis Antwerpen

Edegem, , Belgium

Site Status: RECRUITING

Universitair Ziekenhuis Leuven, Dienst Hart- en Vaatziekten, Cardiale Revalidatie Herestraat 49

Leuven, , Belgium

Site Status: NOT_YET_RECRUITING

Countries

Belgium

Central Contacts

Viviane M Conraads, MD, PhD

Role: CONTACT

Phone: 38214672

Email: Viviane.Conraads@uza.be

Facility Contacts

Viviane M Conraads, MD,PhD

Role: primary

Luc VanHees, MSc, PhD

Role: primary

Other Identifiers

IWT-090870

Identifier Type: -

Identifier Source: org_study_id