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

November 9, 2010 updated by: University Hospital, Antwerp

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

200

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Belgium
      • Edegem, Belgium, 2650
        • Recruiting
        • Dienst Cardiale Revalidatie, Cardiologie, Universitair Ziekenhuis Antwerpen
        • Contact:
      • Leuven, Belgium, 3000
        • Not yet recruiting
        • Universitair Ziekenhuis Leuven, Dienst Hart- en Vaatziekten, Cardiale Revalidatie Herestraat 49
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

40 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Aerobic interval training
Behavioral: 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.
Active Comparator: Moderate endurance training
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Maximal aerobic capacity, measured during symptom-limited cardio-pulmonary exercise testing
Time Frame: 6 weeks
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
Time Frame: 12 weeks
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
Time Frame: 12 months
Comparison of evolution of maximal aerobic capacity, measured during symptom-limited cardio-pulmonary exercise testing
12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospital, Antwerp

Collaborators

Universitaire Ziekenhuizen KU Leuven
KU Leuven

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 2010

Primary Completion (Anticipated)

September 1, 2013

Study Completion (Anticipated)

September 1, 2013

Study Registration Dates

First Submitted

August 19, 2010

First Submitted That Met QC Criteria

October 21, 2010

First Posted (Estimate)

October 22, 2010

Study Record Updates

Last Update Posted (Estimate)

November 10, 2010

Last Update Submitted That Met QC Criteria

November 9, 2010

Last Verified

August 1, 2010

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IWT-090870

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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