Effects of Cardiac Rehabilitation (CR) on Functional Capacity and Cardiovascular Risk Factors
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|ClinicalTrials.gov Identifier: NCT02575976|
Recruitment Status : Completed
First Posted : October 15, 2015
Results First Posted : April 28, 2022
Last Update Posted : April 28, 2022
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|Condition or disease||Intervention/treatment||Phase|
|Cardiovascular Disease Coronary Disease||Behavioral: comprehensive CR Other: exercise-based CR Other: wait list control||Not Applicable|
|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 Assessed by Changes in Total Distance Walked in the Incremental Shuttle Walk Test [ Time Frame: Functional capacity measured by walked distance in the ISWT at 6 months ]The Incremental Shuttle Walk Test (ISWT). The ISWT consists of an incremental, walking test where participants are required to walk up and down a 10-meter course. The speed of walking, which is increased by a small increment every minute (0.17 ms-l), is externally paced and controlled by audio signals played from a tape recorder19. There are 12 levels in total, beginning with 0.5 ms-1, and each level lasts for one minute. At the end of each minute, exercise heart rate (HR) and rating of perceived exertion (RPE) scores will be recorded. For this test, the higher the number of meters, the higher the functional capacity.
- Risk Factors Measurement of Systolic Blood Pressure [ Time Frame: Systolic blood pressure measured at 6 months ]Blood pressure was assessed using the validated 7670-06 mobile stand (Welch Allyn Inc., Skaneateles Falls, NY, USA). Mean systolic blood pressure value was recorded, and hypertension was considered where values exceed 140/90 mmHg and/or participant was taking a blood pressure-lowering medication
- Risk Factors Measurement of Waist Circumference. [ Time Frame: Waist circumference measured at 6 months ]Waist circumference was assessed at the superior border of the iliac crest. Values greater than 102 cm in men and 88 cm in women were considered indicative of central obesity.
- Risk Factors Measurement of Fasting Blood Glucose Values [ Time Frame: Glycaemia measured at 6 months ]Fasting blood glucose values were extracted from center charts. Dysglycemia was considered present where fasting blood glucose exceeded 126 mg/dl and/or participant was taking a glucose-lowering medication
- Risk Factors Measurement of Total Cholesterol Values. [ Time Frame: Cholesterol measured at 6 months. ]Total cholesterol values were extracted from center charts and dyslipidemia was considered present where total cholesterol values exceeded 240 mg/dl and/or participant was on a lipid-lowering agent.
- Heart-health Behaviors [ Time Frame: Measured at 6 months. ]Assessed by questionnaires.
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|Ages Eligible for Study:||18 Years and older (Adult, Older Adult)|
|Sexes Eligible for Study:||All|
|Accepts Healthy Volunteers:||No|
- patients older than 18 years old
- patients living in the Belo Horizonte area
- any comorbid physical or serious mental condition which would interfere with the ability to exercise according to CR clinical practice guidelines (i.e., heart failure with ejection fraction less than 45%, complex ventricular dysrhythmia, advanced dementia, leg amputation, advanced cancer, disabling stroke, Parkinson's or substance dependence), and
- any visual or cognitive condition which would preclude the participant from completing the 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|
Documents provided by Raquel Rodrigues Britto, Federal University of Minas Gerais:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
|Responsible Party:||Raquel Rodrigues Britto, PhD, Federal University of Minas Gerais|
|Other Study ID Numbers:||
|First Posted:||October 15, 2015 Key Record Dates|
|Results First Posted:||April 28, 2022|
|Last Update Posted:||April 28, 2022|
|Last Verified:||April 2022|
|Individual Participant Data (IPD) Sharing Statement:|
|Plan to Share IPD:||No|
Coronary artery disease
Randomized Controlled Trial