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Completed

NCT Number: NCT02516293

Cardiac Rehabilitation in Chagas Heart Failure

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2 / Phase 3

Primary location

Evandro Chagas National Institute of Infectious Disease

Rio de Janeiro, 21040-360, Brazil

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Exercise, nutritional and pharmaceutical counseling

Behavioral

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 outcomes

  1. Functional Capacity (VO2 max)

    Time frame: Change from baseline at 4 and 8 months

    VO2 max (ml/kg/min)

Secondary outcomes

  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)

Sponsors and collaborators

Lead sponsor

Evandro Chagas National Institute of Infectious Disease

Other

Registry information

Official study title

Cardiac Rehabilitation Program in Patients With Chagas Heart Failure: a Pilot Study

Important dates

Study start
2013
Primary completion
2014
Study completion
2014
First posted
Aug 5, 2015
Registry last updated
Aug 5, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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