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

Brief Summary

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

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.

  • Study Type: Interventional
  • Study Design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment
  • Study Primary Completion Date: June 2010

Detailed Clinical Trial 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.

Interventions Used in this Clinical Trial

  • Behavioral: Supervised exercise on a stationary bicycle, 3-5 days a week
    • Supervised exercise on a stationary bicycle, 3-5 days a week, plus a secondary prevention program for coronary heart disease
  • Behavioral: Secondary prevention program for coronary heart disease
    • Secondary prevention program for coronary heart disease

Arms, Groups and Cohorts in this Clinical Trial

  • Active Comparator: Control
    • Secondary prevention program for coronary heart disease
  • Experimental: Supervised exercise

Outcome Measures for this Clinical Trial

Primary Measures

  • Functional capacity (exercise treadmill test)
    • Time Frame: 6 months follow-up
      Safety Issue?: No

Secondary Measures

  • Health Related Quality of life (SF-36)
    • Time Frame: 6 months follow-up
      Safety Issue?: No
  • Cardiovascular risk factor control
    • Time Frame: 6 months follow-up
      Safety Issue?: Yes

Criteria for Participation in this Clinical Trial

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

Gender Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: 20 Years

Maximum Age for this Clinical Trial: 79 Years

Are Healthy Volunteers Accepted for this Clinical Trial: No

Clinical Trial Investigator Information

  • Lead Sponsor
    • Basque Health Service
  • Collaborator
    • Preventive Services and Health Promotion Research Network
  • Provider of Information About this Clinical Study
    • Ricardo Ortega, Castilla La Mancha Health Service
  • Overall Official(s)
    • Ricardo Ortega, Dr., Principal Investigator, Santa Barbara primary care center (Castilla La Mancha Health Service)

References

Ortega Sanchez-Pinilla R. [Differences in intensity of effort between supervised and non-supervised exercise of patients with ischaemic cardiopathy] Aten Primaria. 2004 Sep 30;34(5):265-6. Spanish. No abstract available.

Source

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The URL of this page is:
http://clinicaltrialsfeeds.org/clinical-trials/show/NCT00146315