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Cardiac Rehabilitation in Chagas Heart Failure

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

Status
Completed
Phases
Phase 2Phase 3
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02516293
Enrollment
12
Registered
2015-08-05
Start date
2013-05-31
Completion date
2014-12-31
Last updated
2015-08-05

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Chagas Cardiomyopathy, Chagas 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.

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.

Interventions

BEHAVIORALExercise, 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.

Sponsors

Evandro Chagas National Institute of Infectious Disease
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
Functional Capacity (VO2 max)Change from baseline at 4 and 8 monthsVO2 max (ml/kg/min)

Secondary

MeasureTime frameDescription
Muscle respiratory strength (maximal inspiratory pressure and maximal expiratory pressure)Change from baseline at 4 and 8 monthsMaximal inspiratory pressure and maximal expiratory pressure (cm H2O)
Body composition (body fat percentage)Change from baseline at 4 and 8 monthsBody fat percentage (%)
Cardiac function (mainly ejection fraction)Change from baseline at 8 monthsEjection fraction (%)
Biomarkers (lipid profile and glucose)Change from baseline at 8 monthsTotal cholesterol, Triacylglycerol, HDL-cholesterol, LDL-cholesterol, VLDL-cholesterol (mg/dl) and glucose (mg/dl)
Biomarkers (glycated hemoglobin)Change from baseline at 8 monthsGlycated hemoglobin (%)
Quality of life by Minnesota Living with heart failure questionnaire (MLHFQ)Change from baseline at 8 monthsMLHFQ Score ranging from 0 to 105
AnthropometryChange from baseline at 4 and 8 monthsBody weight (kg)

Countries

Brazil

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026