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Cardiac Rehabilitation in Chagas Heart Failure

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ClinicalTrials.gov Identifier: NCT02516293
Recruitment Status : Completed
First Posted : August 5, 2015
Last Update Posted : August 5, 2015
Sponsor:
Information provided by (Responsible Party):
Mauro Felippe Felix Mediano, Evandro Chagas National Institute of Infectious Disease

Brief Summary:
Due to the lack of information in the literature about the role of cardiac rehabilitation on Chagas heart failure, the aim of the present study was to evaluate the effects of a cardiac exercise program on functional capacity, cardiac function, respiratory muscle strength, body composition, biomarkers and quality of life among Chagas heart failure patients.

Condition or disease Intervention/treatment Phase
Chagas Disease Chagas Cardiomyopathy Behavioral: Exercise, nutritional and pharmaceutical counseling Phase 2 Phase 3

Detailed Description:
The present study consisted in a pre/post single-arm intervention study conducted at the Evandro Chagas National Institute of Infectious Disease (INI), located on Rio de Janeiro, Brazil. INI is a national reference center for treatment and research in infectious diseases and tropical medicine in Brazil, which follows a large cohort of patients with Chagas disease, all of them diagnosed by two simultaneously positive serological tests (enzyme-linked immunosorbent assay and indirect immunofluorescence). Patients included in the study were submitted to a physical exercise intervention protocol performed three times per week, 60 minutes per session, during an 8-month period. Nutritional and pharmaceutical counseling were also monthly provided during the follow-up and consisted on general guidance about adequate eating habits for patients with heart failure, mainly sodium and water intake, and medication usage, particularly drug dosage and compliance.Patients included in the study were followed during an 8-month period in which evaluations of functional capacity (maximal progressive cardiopulmonary exercise test), muscle respiratory strength (manovacuometry) and body composition (anthropometry and skinfolds) were performed at baseline, after four months and at the end of follow-up. Assessments of cardiac function (bidimensional echocardiography), biomarkers (lipid profile, glucose and glycated hemoglobin) and quality of life (Minnesota Living with Heart Failure questionnaire) were taken at baseline and after eight months of follow-up.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 12 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Cardiac Rehabilitation Program in Patients With Chagas Heart Failure: a Pilot Study
Study Start Date : May 2013
Actual Primary Completion Date : January 2014
Actual Study Completion Date : December 2014

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Intervention group
  • Physical exercise intervention
  • Nutritional counseling
  • Pharmaceutical counseling
Behavioral: Exercise, nutritional and pharmaceutical counseling
Physical exercise intervention protocol was performed three times per week, 60 minutes per session, during 8 months. Exercise sessions consisted of 30 minutes of aerobic exercise on a treadmill or on a cycle ergometer, 20 minutes of strength exercises for the major muscle groups (sit-ups, push-ups, and pull-ups), and 10 minutes of stretching exercises. Nutritional and pharmaceutical consisted on general guidance about adequate eating habits for patients with heart failure, mainly sodium and water intake, and medication usage, particularly drug dosage and compliance.




Primary Outcome Measures :
  1. Functional Capacity (VO2 max) [ Time Frame: Change from baseline at 4 and 8 months ]
    VO2 max (ml/kg/min)


Secondary Outcome Measures :
  1. Muscle respiratory strength (maximal inspiratory pressure and maximal expiratory pressure) [ Time Frame: Change from baseline at 4 and 8 months ]
    Maximal inspiratory pressure and maximal expiratory pressure (cm H2O)

  2. Body composition (body fat percentage) [ Time Frame: Change from baseline at 4 and 8 months ]
    Body fat percentage (%)

  3. Cardiac function (mainly ejection fraction) [ Time Frame: Change from baseline at 8 months ]
    Ejection fraction (%)

  4. Biomarkers (lipid profile and glucose) [ Time Frame: Change from baseline at 8 months ]
    Total cholesterol, Triacylglycerol, HDL-cholesterol, LDL-cholesterol, VLDL-cholesterol (mg/dl) and glucose (mg/dl)

  5. Biomarkers (glycated hemoglobin) [ Time Frame: Change from baseline at 8 months ]
    Glycated hemoglobin (%)

  6. Quality of life by Minnesota Living with heart failure questionnaire (MLHFQ) [ Time Frame: Change from baseline at 8 months ]
    MLHFQ Score ranging from 0 to 105

  7. Anthropometry [ Time Frame: Change from baseline at 4 and 8 months ]
    Body weight (kg)

  8. Anthropometry [ Time Frame: Change from baseline at 4 and 8 months ]
    Waist and hip circumference (cm)



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

Inclusion Criteria:

  • Patients at the stages C or D of Chagas cardiomyopathy
  • Patients receiving standard optimized medical therapy
  • Patients with good adherence to outpatient treatment within the last three months.

Exclusion Criteria:

  • Those who were not able to attend three weekly training sessions,
  • Those who had neuromuscular limitations, cardiopathies from non-Chagasic etiology (e.g ischemic), systemic conditions that limits exercise practice (e.g chronic obstructive pulmonary disease)
  • Practitioners of regular exercise.

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): NCT02516293


Locations
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Brazil
Evandro Chagas National Institute of Infectious Disease
Rio de Janeiro, RJ, Brazil, 21040-360
Sponsors and Collaborators
Evandro Chagas National Institute of Infectious Disease
Investigators
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Principal Investigator: Andrea S Sousa, PhD Evandro Chagas National Institute of Infectious Disease

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Responsible Party: Mauro Felippe Felix Mediano, Clinical Researcher in Public Health, Evandro Chagas National Institute of Infectious Disease
ClinicalTrials.gov Identifier: NCT02516293     History of Changes
Other Study ID Numbers: CAAE 0055.0.009.000-11
First Posted: August 5, 2015    Key Record Dates
Last Update Posted: August 5, 2015
Last Verified: August 2015
Additional relevant MeSH terms:
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Chagas Disease
Chagas Cardiomyopathy
Heart Failure
Cardiomyopathies
Heart Diseases
Cardiovascular Diseases
Trypanosomiasis
Euglenozoa Infections
Protozoan Infections
Parasitic Diseases