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Completed

NCT Number: NCT00146315

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

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.

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Key information

Age range

20 year–79 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Primary Care Research Unit of Bizkaia (Basque Health Service), Bilbao, Bizkaia, Spain

Loading trial locations.

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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

Behavioral

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

Behavioral

Secondary prevention program for coronary heart disease

Primary outcomes

  1. Functional capacity (exercise treadmill test)

    Time frame: 6 months follow-up

Secondary outcomes

  1. Health Related Quality of life (SF-36)

    Time frame: 6 months follow-up

  2. Cardiovascular risk factor control

    Time frame: 6 months follow-up

Sponsors and collaborators

Lead sponsor

Basque Health Service

Other Gov

Collaborators

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

Registry information

Official study title

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

Important dates

Study start
2005
Primary completion
2010
Study completion
2010
First posted
Sep 7, 2005
Registry last updated
Jun 1, 2011

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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