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

NCT01226225 | Unknown Phase 3

• 1 other identifier: IWT-090870
• Study Type: interventional
• Target: 200
• Locations: 1 country
• Sites: 2

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

Outcome Measures

Primary Outcomes (3)

• Maximal aerobic capacity, measured during symptom-limited cardio-pulmonary exercise testing

  Comparison of evolution of maximal aerobic capacity from baseline to 6 weeks

  6 weeks

• Maximal aerobic capacity, measured during symptom-limited cardio-pulmonary exercise testing

  Comparison of evolution of maximal aerobic capacity from baseline to 12 weeks

  12 weeks

• Maximal aerobic capacity, measured during symptom-limited cardio-pulmonary exercise testing

  Comparison of evolution of maximal aerobic capacity, measured during symptom-limited cardio-pulmonary exercise testing

  12 months

Study Arms (2)

Aerobic interval training

EXPERIMENTAL

Behavioral: Aerobic interval training

Moderate endurance training

ACTIVE COMPARATOR

Behavioral: Moderate endurance training

Interventions

Aerobic interval training 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.

Aerobic interval training

Moderate endurance training 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.

Moderate endurance training

Eligibility Criteria

• Age: 40 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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
• 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

Sponsors & Collaborators

• University Hospital, Antwerp: lead
• KU Leuven: collaborator
• Universitaire Ziekenhuizen KU Leuven: collaborator

Study Sites (2)

Dienst Cardiale Revalidatie, Cardiologie, Universitair Ziekenhuis Antwerpen

Edegem, 2650, Belgium

RECRUITING

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

Leuven, 3000, Belgium

NOT YET RECRUITING

MeSH Terms

Conditions

Coronary Artery Disease; Myocardial Infarction

Condition Hierarchy (Ancestors)

Coronary Disease; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases; Infarction; Ischemia; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Necrosis

Central Study Contacts

Viviane M Conraads, MD, PhD

CONTACT

38214672; Viviane.Conraads@uza.be

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: August 19, 2010
• First Posted: October 22, 2010
• Study Start: November 1, 2010
• Primary Completion: September 1, 2013
• Study Completion: September 1, 2013
• Last Updated: November 10, 2010

Record last verified: 2010-08

Locations

BE (2)