Effects of Cardiac Rehabilitation on Functional Capacity and Cardiovascular Risk Factors
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT02575976|
Recruitment Status : Completed
First Posted : October 15, 2015
Last Update Posted : March 13, 2018
|Condition or disease||Intervention/treatment||Phase|
|Cardiovascular Disease Coronary Disease||Behavioral: comprehensive CR Other: exercise-based CR Other: wait list control||Not Applicable|
Show Detailed Description
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||115 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Single (Outcomes Assessor)|
|Official Title:||Effects of Cardiac Rehabilitation on Functional Capacity and Cardiovascular Risk Factors in Brazilian Patients Assisted by Public Health Care: A Randomized Controlled Trial|
|Study Start Date :||March 2015|
|Actual Primary Completion Date :||October 2017|
|Actual Study Completion Date :||October 2017|
Experimental: comprehensive CR
education and exercise-based cardiac rehabilitation
Behavioral: comprehensive CR
In the comprehensive CR arm, 24 sessions education will be offered, of 30 minutes duration beyond the exercises already performed in the cardiac rehabilitation program (The main program is 6 months in duration, with 36 1-hour exercise sessions)
Active Comparator: exercise-based CR
Exercise-based cardiac rehabilitation
Other: exercise-based CR
The main program is 6 months in duration, with 36 1-hour exercise sessions.
wait list control
no cardiac rehabilitation
Other: wait list control
No cardiac rehabilitation.
- Functional capacity [ Time Frame: Change from Baseline functional capacity at 6 months and 12 months ]Will be analyzed using the Incremental Shuttle walk test (ISWT)
- Risk Factors [ Time Frame: Change from Baseline blood pressure at 6 months and 12 months ]Will be assessed blood pressure.
- Risk Factors [ Time Frame: Change from Baseline waist circumference at 6 months and 12 months ]Will be assessed waist circumference.
- Risk Factors [ Time Frame: Change from Baseline glycaemia at 6 months and 12 months ]Fasting blood glucose values will be extracted from centre charts.
- Risk Factors [ Time Frame: Change from Baseline lipids at 6 months and 12 months ]Total cholesterol values will be extracted from centre charts.
- Heart-health Behaviors [ Time Frame: Change from Baseline scores at 6 months and 12 months ]Will be assessed by questionnaires
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02575976
|Federal University of Minas Gerais|
|Belo Horizonte, Minas Gerais, Brazil, 31270-901|
|Principal Investigator:||Raquel R Britto, Post doc||Federal University of Minas Gerais|