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

Phase 3

• Conditions: Coronary Artery Disease (CAD); Myocardial Infarction (MI); Percutaneous Coronary Intervention (PCI); Coronary Artery Bypass Grafting (CABG)
• Interventions: Behavioral: Aerobic interval training; Behavioral: Moderate endurance training

• Registration Number: NCT01226225
• Lead Sponsor: University Hospital, Antwerp

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2010-08
• Study First Submitted: 2010-08-19
• Study First Submitted QC: 2010-10-21
• Study First Posted: 2010-10-22
• Study Start: 2010-11
• Last Update Submitted: 2010-11-09
• Last Update Posted: 2010-11-10
• Primary Completion: 2013-09
• Study Completion: 2013-09

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 200

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Aerobic interval training	Aerobic interval training	-
Moderate endurance training	Moderate endurance training	-

Primary Outcome Measures

Name	Time	Method
Maximal aerobic capacity, measured during symptom-limited cardio-pulmonary exercise testing	12 months	Comparison of evolution of maximal aerobic capacity, measured during symptom-limited cardio-pulmonary exercise testing

Trial Locations

Locations (2)

Universitair Ziekenhuis Leuven, Dienst Hart- en Vaatziekten, Cardiale Revalidatie Herestraat 49; 🇧🇪 Leuven, Belgium

Dienst Cardiale Revalidatie, Cardiologie, Universitair Ziekenhuis Antwerpen; 🇧🇪 Edegem, Belgium