ESCAP: Supervised Exercise for Patients With Coronary Heart Disease in the Primary Care Setting
Condition: Coronary Heart Disease
MeSH terms: Heart Diseases; Coronary Disease; Coronary Artery Disease; Myocardial Ischemia
Study type: Interventional
Phase: Phase 3

Summary: 
      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: 
      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.
    

Intervention name(s): Supervised exercise on a stationary bicycle, 3-5 days a week; Secondary prevention program for coronary heart disease
Intervention type(s): Behavioral; Behavioral
Intervention description(s): Supervised exercise on a stationary bicycle, 3-5 days a week, plus a secondary prevention program for coronary heart disease; Secondary prevention program for coronary heart disease
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Keywords: Primary Health Care; Family Practice; Family Physician; Exercise; Coronary Heart Disease; Randomized Controlled Trials; Multicenter Studies