ESCAP: Supervised Exercise for Patients With Coronary Heart Disease in the Primary Care Setting
Effectiveness of the Supervised Exercise for Patients With Coronary Heart Disease in the Primary Care Setting (ESCAP): a Randomized Clinical Trial
Study Overview
Status
Conditions
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
Enrollment (Actual)
Phase
- Phase 3
Contacts and Locations
Study Locations
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Toledo, Spain, 45007
- Santa Barbara primary care center (Castilla La Mancha Health Service)
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Bizkaia
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Bilbao, Bizkaia, Spain, 48014
- Primary Care Research Unit of Bizkaia (Basque Health Service)
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
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
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 |
|---|---|
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Active Comparator: Control
Secondary prevention program for coronary heart disease
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Secondary prevention program for coronary heart disease
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Experimental: Supervised exercise
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Supervised exercise on a stationary bicycle, 3-5 days a week, plus a secondary prevention program for coronary heart disease
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
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Functional capacity (exercise treadmill test)
Time Frame: 6 months follow-up
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6 months follow-up
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Secondary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
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Health Related Quality of life (SF-36)
Time Frame: 6 months follow-up
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6 months follow-up
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Cardiovascular risk factor control
Time Frame: 6 months follow-up
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6 months follow-up
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Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Ricardo Ortega, Dr., Santa Barbara primary care center (Castilla La Mancha Health Service)
Publications and helpful links
General Publications
- 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. doi: 10.1016/s0212-6567(04)70847-1. No abstract available. Spanish.
- Ortega R, Garcia-Ortiz L, Torcal J, Echevarria P, Vargas-Machuca C, Gomez A, Salcedo F, Lekuona I, Montoya I, Grandes G; ESCAP Group. Supervised exercise for acute coronary patients in primary care: a randomized clinical trial. Fam Pract. 2014 Feb;31(1):20-9. doi: 10.1093/fampra/cmt059. Epub 2013 Oct 19.
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- ESCAP-G03/170-200311075
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