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

Primary Purpose

Coronary Artery Disease (CAD);, Myocardial Infarction (MI), Percutaneous Coronary Intervention (PCI)

Status

Unknown status

Phase

Phase 3

Locations

Belgium

Study Type

Interventional

Intervention

Aerobic interval training

Moderate endurance training

About this trial

This is an interventional treatment trial for Coronary Artery Disease (CAD); focused on measuring Patients with recent coronary event

Eligibility Criteria

40 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

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

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Aerobic interval training

Moderate endurance training

Arm Description

Outcomes

Primary Outcome Measures

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

Comparison of evolution of maximal aerobic capacity from baseline to 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

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

Secondary Outcome Measures

Full Information

NCT ID

NCT01226225

First Posted

August 19, 2010

Last Updated

November 9, 2010

Sponsor

University Hospital, Antwerp

Collaborators

KU Leuven, Universitaire Ziekenhuizen KU Leuven

1. Study Identification

Unique Protocol Identification Number

NCT01226225

Brief Title

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

Acronym

SAINTEX-CAD

Study Type

Interventional

2. Study Status

Record Verification Date

August 2010

Overall Recruitment Status

Unknown status

Study Start Date

November 2010 (undefined)

Primary Completion Date

September 2013 (Anticipated)

Study Completion Date

September 2013 (Anticipated)

3. Sponsor/Collaborators

Name of the Sponsor

University Hospital, Antwerp

Collaborators

KU Leuven, Universitaire Ziekenhuizen KU Leuven

4. Oversight

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

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

Keywords

Patients with recent coronary event

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 3

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

200 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Aerobic interval training

Arm Type

Experimental

Arm Title

Moderate endurance training

Arm Type

Active Comparator

Intervention Type

Behavioral

Intervention Name(s)

Aerobic interval training

Intervention Description

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

Intervention Name(s)

Moderate endurance training

Intervention Description

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.

Primary Outcome Measure Information:

Title

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

Description

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

Time Frame

6 weeks

Title

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

Description

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

Time Frame

12 weeks

Title

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

Description

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

Time Frame

12 months

10. Eligibility

Sex

All

Minimum Age & Unit of Time

40 Years

Maximum Age & Unit of Time

75 Years

Accepts Healthy Volunteers

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

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Viviane M Conraads, MD, PhD

Phone

38214672

Ext

0032

Viviane.Conraads@uza.be

Facility Information:

Facility Name

Dienst Cardiale Revalidatie, Cardiologie, Universitair Ziekenhuis Antwerpen

City

Edegem

ZIP/Postal Code

2650

Country

Belgium

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Viviane M Conraads, MD,PhD

Phone

38214672

Ext

0032

Viviane.Conraad@uza.be

Facility Name

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

City

Leuven

ZIP/Postal Code

3000

Country

Belgium

Individual Site Status

Not yet recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Luc VanHees, MSc, PhD

Phone

16-329158

Ext

0032

Luc.Vanhees@faber.kuleuven.be

12. IPD Sharing Statement

Learn more about this trial

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

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