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

Coronary Heart Disease Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00146315
• Other study ID #: ESCAP-G03/170-200311075
• Status: Completed
• Phase: Phase 3
• First received: September 6, 2005
• Last updated: May 31, 2011
• Start date: January 2005
• Est. completion date: June 2010

Study information

• Verified date: May 2011
• Source: Basque Health Service
• Contact: n/a
• Is FDA regulated: No
• Health authority: Spain: Ministry of Health
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 97
• Est. completion date: June 2010
• Est. primary completion date: June 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 20 Years to 79 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Coronary Artery Disease
• Coronary Disease
• Coronary Heart Disease
• Heart Diseases
• Myocardial Ischemia

Intervention

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
• Secondary prevention program for coronary heart disease
Secondary prevention program for coronary heart disease

Locations

Country	Name	City	State
Spain	Primary Care Research Unit of Bizkaia (Basque Health Service)	Bilbao	Bizkaia
Spain	Santa Barbara primary care center (Castilla La Mancha Health Service)	Toledo

Sponsors (9)

Lead Sponsor	Collaborator
Basque Health Service	Cantabria 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, Santa Bárbara and Cuenca primary care centers(Castilla La Mancha Health Service)

Country where clinical trial is conducted

Spain, 

References & Publications (1)

Ortega Sánchez-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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Functional capacity (exercise treadmill test)		6 months follow-up	No
Secondary	Health Related Quality of life (SF-36)		6 months follow-up	No
Secondary	Cardiovascular risk factor control		6 months follow-up	Yes