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

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Effectiveness of the Supervised Exercise for Patients With Coronary Heart Disease in the Primary Care Setting (ESCAP): a Randomized Clinical Trial

Conditions
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Coronary Heart Disease

Intervention / Treatment
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* Behavioral: Supervised exercise on a stationary bicycle, 3-5 days a week
* Behavioral: Secondary prevention program for coronary heart disease


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 79 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Control<br>Secondary prevention program for coronary heart disease | Behavioral: Secondary prevention program for coronary heart disease<br>* Secondary prevention program for coronary heart disease<br>|
| Experimental: Supervised exercise<br> | Behavioral: Supervised exercise on a stationary bicycle, 3-5 days a week<br>* Supervised exercise on a stationary bicycle, 3-5 days a week, plus a secondary prevention program for coronary heart disease<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Functional capacity (exercise treadmill test) |  | 6 months follow-up | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Health Related Quality of life (SF-36) |  | 6 months follow-up | 
| Cardiovascular risk factor control |  | 6 months follow-up | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Primary Health Care, Family Practice, Family Physician, Exercise, Coronary Heart Disease, Randomized Controlled Trials, Multicenter Studies