Trial record 1 of 18397 for:    coronary heart disease
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ESCAP: Supervised Exercise for Patients With Coronary Heart Disease in the Primary Care Setting

This study has been completed.
Sponsor:
Collaborators:
Preventive Services and Health Promotion Research Network
Santa Bárbara and Cuenca primary care centers(Castilla La Mancha Health Service)
Castilla-León Health Service
Dalt Sant Joan primary care center (Balears Islans Health Service)
Public Health Service of Cataluña
Public Health Service of Madrid
Public Health Service of Galicia
Cantabria Health Service
Information provided by:
Basque Health Service
ClinicalTrials.gov Identifier:
NCT00146315
First received: September 6, 2005
Last updated: May 31, 2011
Last verified: May 2011
  Purpose

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.


Condition Intervention Phase
Coronary Heart Disease
Behavioral: Supervised exercise on a stationary bicycle, 3-5 days a week
Behavioral: Secondary prevention program for coronary heart disease
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Effectiveness of the Supervised Exercise for Patients With Coronary Heart Disease in the Primary Care Setting (ESCAP): a Randomized Clinical Trial

Resource links provided by NLM:


Further study details as provided by Basque Health Service:

Primary Outcome Measures:
  • Functional capacity (exercise treadmill test) [ Time Frame: 6 months follow-up ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Health Related Quality of life (SF-36) [ Time Frame: 6 months follow-up ] [ Designated as safety issue: No ]
  • Cardiovascular risk factor control [ Time Frame: 6 months follow-up ] [ Designated as safety issue: Yes ]

Enrollment: 97
Study Start Date: January 2005
Study Completion Date: June 2010
Primary Completion Date: June 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.

  Eligibility

Ages Eligible for Study:   20 Years to 79 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00146315

Locations
Spain
Primary Care Research Unit of Bizkaia (Basque Health Service)
Bilbao, Bizkaia, Spain, 48014
Santa Barbara primary care center (Castilla La Mancha Health Service)
Toledo, Spain, 45007
Sponsors and Collaborators
Basque Health Service
Preventive Services and Health Promotion Research Network
Santa Bárbara and Cuenca primary care centers(Castilla La Mancha Health Service)
Castilla-León Health Service
Dalt Sant Joan primary care center (Balears Islans Health Service)
Public Health Service of Cataluña
Public Health Service of Madrid
Public Health Service of Galicia
Cantabria Health Service
Investigators
Principal Investigator: Ricardo Ortega, Dr. Santa Barbara primary care center (Castilla La Mancha Health Service)
  More Information

Additional Information:
Publications:
Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Ricardo Ortega, Castilla La Mancha Health Service
ClinicalTrials.gov Identifier: NCT00146315     History of Changes
Other Study ID Numbers: ESCAP-G03/170-200311075
Study First Received: September 6, 2005
Last Updated: May 31, 2011
Health Authority: Spain: Ministry of Health

Keywords provided by Basque Health Service:
Primary Health Care
Family Practice
Family Physician
Exercise
Coronary Heart Disease
Randomized Controlled Trials
Multicenter Studies

Additional relevant MeSH terms:
Coronary Artery Disease
Myocardial Ischemia
Coronary Disease
Heart Diseases
Cardiovascular Diseases
Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases

ClinicalTrials.gov processed this record on July 20, 2014