Working...
ClinicalTrials.gov
ClinicalTrials.gov Menu

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
Sponsor:
Information provided by (Responsible Party):
Raquel Rodrigues Britto, Federal University of Minas Gerais

Brief Summary:
The purpose of this trial are to pragmatically investigate whether participation in a comprehensive CR (i.e., exercise with education) program in a Latin American MIC results in better functional capacity, cardiovascular risk factor control, health behavior, disease-related knowledge, depressive symptoms and lower mortality when compared exercise only CR or wait list control.

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

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 115 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
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

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
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.




Primary Outcome Measures :
  1. 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)


Secondary Outcome Measures :
  1. Risk Factors [ Time Frame: Change from Baseline blood pressure at 6 months and 12 months ]
    Will be assessed blood pressure.

  2. Risk Factors [ Time Frame: Change from Baseline waist circumference at 6 months and 12 months ]
    Will be assessed waist circumference.

  3. Risk Factors [ Time Frame: Change from Baseline glycaemia at 6 months and 12 months ]
    Fasting blood glucose values will be extracted from centre charts.

  4. Risk Factors [ Time Frame: Change from Baseline lipids at 6 months and 12 months ]
    Total cholesterol values will be extracted from centre charts.


Other Outcome Measures:
  1. Heart-health Behaviors [ Time Frame: Change from Baseline scores at 6 months and 12 months ]
    Will be assessed by questionnaires



Information from the National Library of Medicine

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, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • patients older than 18 years old
  • patients living in the Belo Horizonte area

Exclusion Criteria:

  • 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.

Information from the National Library of Medicine

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


Locations
Layout table for location information
Brazil
Federal University of Minas Gerais
Belo Horizonte, Minas Gerais, Brazil, 31270-901
Sponsors and Collaborators
Federal University of Minas Gerais
Investigators
Layout table for investigator information
Principal Investigator: Raquel R Britto, Post doc Federal University of Minas Gerais

Publications of Results:
Other Publications:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Layout table for additonal information
Responsible Party: Raquel Rodrigues Britto, PhD, Federal University of Minas Gerais
ClinicalTrials.gov Identifier: NCT02575976     History of Changes
Other Study ID Numbers: RCT-898235
First Posted: October 15, 2015    Key Record Dates
Last Update Posted: March 13, 2018
Last Verified: March 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Keywords provided by Raquel Rodrigues Britto, Federal University of Minas Gerais:
Rehabilitation
Coronary artery disease
Patient Education
Randomized Controlled Trial
Protocol

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