ESCAP: Supervised Exercise for Patients With Coronary Heart Disease in the Primary Care Setting

Basque Health Service

Status and phase

Completed

Phase 3

Conditions

Coronary Heart Disease

Treatments

Behavioral: Supervised exercise on a stationary bicycle, 3-5 days a week

Behavioral: Secondary prevention program for coronary heart disease

Study type

Interventional

Funder types

Other

Identifiers

NCT00146315

ESCAP-G03/170-200311075

Details and patient eligibility

About

In Spain, family physician are currently recommended to prescribe an unsupervised walking program to their coronary heart disease (CHD) patients as a part of their cardiac rehabilitation program. However, there are a few family physicians who provide their CHD patients with supervised exercise (30 minutes of pedaling on an stationary bicycle at 60-85% of the peak heart rate (HR) attained at the maximal or symptom limited treadmill test, 3 times a week) at their primary care health centers, thinking that these patients improve their functional capacity, quality of life, and the control of cardiovascular risk factors, more than walking because they can not achieve the ideal exercise intensity for maximal benefits by walking. This study has been designed to investigate if CHD patients get more health benefits with the supervised exercise program at the health center than with the unsupervised walking program.

Full description

In order to obtain the maximal health benefits, CHD patients have to attain an exercise intensity between 60 and 85% of the maximal or symptom-limited heart rate (HR). This is not currently attained by the patients who are prescribed an unsupervised walking program.

The OBJECTIVE of this randomized clinical trial is to investigate if CHD patients improve their functional capacity and quality of life more, and control their cardiovascular risk factors better, by coming to their health centers to pedal during 30 minutes on an stationary bicycle , 3 or more times a week, with a HR monitor which makes sure that they attain HRs within the prescribed interval, and supervised by health personal, than by walking without supervision. For that purpose, low risk CHD patients from 11 Spanish health centers will be randomly assigned to a supervised exercise group (ESCAP) or to another unsupervised walking group (control). Both groups will be also provided with health education and the corresponding treatment for cardiovascular risk factor control and complication prevention by their family physicians. The average changes observed in the two groups will be compared, on the basis of intention to treat through analysis of covariance. We will use mixed-effect models to take into account intra-patients and intra-center correlation.

Enrollment

97 patients

Sex

All

Ages

20 to 79 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

Coronary heart disease low risk patients
Under 80 years old

Exclusion criteria

80 years of age and over
Patients included in cardiac rehabilitation programs
Moderate and high risk patients
Patients with handicaps for exercising
Patients unable to attend the supervised exercise sessions
Unstable angina
Uncontrolled atrial ventricular arrhythmias
Third degree AV block (without pacemaker)
Uncompensated congestive heart failure
Severe aortic stenosis
Suspected or known dissecting aneurysm
Active myocarditis or pericarditis
Thrombophlebitis
Recent embolism
Acute systemic illness or fever
Significant emotional distress (psychosis)
Orthostatic blood pressure drop of >20 mm Hg with symptoms
Uncontrolled sinus tachycardia
Resting ST segment displacement (>2 mm)
Uncontrolled diabetes (resting blood glucose >400 mg/dl)
Other metabolic problems such as acute thyroiditis, hypo or hyperkalemia, hypovolemia, etc.
Resting SBP>200 mm Hg or resting DBP>110 mm Hg