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

May 31, 2011 updated by: Basque Health Service

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 Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

97

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Spain
      • Toledo, Spain, 45007
        • Santa Barbara primary care center (Castilla La Mancha Health Service)
    • Bizkaia
      • Bilbao, Bizkaia, Spain, 48014
        • Primary Care Research Unit of Bizkaia (Basque Health Service)

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years to 79 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Control
Secondary prevention program for coronary heart disease
Behavioral: Secondary prevention program for coronary heart disease
Secondary prevention program for coronary heart disease
Experimental: Supervised exercise
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

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Basque Health Service

Collaborators

Preventive Services and Health Promotion Research Network
Castilla-León Health Service
Castilla-La Mancha Health Service
Public Health Service of Madrid
Public Health Service of Galicia
Public Health Service of Cataluña
Dalt Sant Joan primary care center (Balears Islans Health Service)
Cantabria Health Service

Investigators

  • Principal Investigator: Ricardo Ortega, Dr., Santa Barbara primary care center (Castilla La Mancha Health Service)

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2005

Primary Completion (Actual)

June 1, 2010

Study Completion (Actual)

June 1, 2010

Study Registration Dates

First Submitted

September 6, 2005

First Submitted That Met QC Criteria

September 6, 2005

First Posted (Estimate)

September 7, 2005

Study Record Updates

Last Update Posted (Estimate)

June 1, 2011

Last Update Submitted That Met QC Criteria

May 31, 2011

Last Verified

May 1, 2011

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ESCAP-G03/170-200311075

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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