Ignite Creation Date:
2024-05-05 @ 11:49 AM
Last Modification Date:
2024-10-26 @ 9:14 AM
Study NCT ID:
NCT00146315
Status:
COMPLETED
Last Update Posted:
2011-06-01
First Post:
2005-09-06
Brief Title:
ESCAP Supervised Exercise for Patients With Coronary Heart Disease in the Primary Care Setting
Sponsor:
Basque Health Service
Organization:
Basque Health Service
Study Overview
Official Title:
Effectiveness of the Supervised Exercise for Patients With Coronary Heart Disease in the Primary Care Setting ESCAP a Randomized Clinical Trial
Status:
COMPLETED
Status Verified Date:
2011-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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
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
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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None