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| Name | Class |
|---|---|
| Preventive Services and Health Promotion Research Network | OTHER |
| Castilla-La Mancha Health Service | OTHER |
| Castilla-LeĂłn Health Service | OTHER |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Control | Active Comparator | Secondary prevention program for coronary heart disease |
|
| Supervised exercise | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Functional capacity (exercise treadmill test) | 6 months follow-up |
| Measure | Description | Time Frame |
|---|---|---|
| Health Related Quality of life (SF-36) | 6 months follow-up | |
| Cardiovascular risk factor control | 6 months follow-up |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Ricardo Ortega, Dr. | Santa Barbara primary care center (Castilla La Mancha Health Service) | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Primary Care Research Unit of Bizkaia (Basque Health Service) | Bilbao | Bizkaia | 48014 | Spain | ||
| Santa Barbara primary care center (Castilla La Mancha Health Service) |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 15456577 | Background | 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. | |
| 24142481 | Derived | 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. |
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| Dalt Sant Joan primary care center (Balears Islans Health Service) |
| UNKNOWN |
| Public Health Service of Cataluña | OTHER |
| Public Health Service of Madrid | OTHER |
| Public Health Service of Galicia | OTHER |
| Cantabria Health Service | OTHER |
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| Secondary prevention program for coronary heart disease | Behavioral | Secondary prevention program for coronary heart disease |
|
| Toledo |
| Toledo |
| 45007 |
| Spain |
| ID | Term |
|---|---|
| D003327 | Coronary Disease |
| D009043 | Motor Activity |
| ID | Term |
|---|---|
| D017202 | Myocardial Ischemia |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D014652 | Vascular Diseases |
| D001519 | Behavior |
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