Cardiac Rehabilitation in Chagas Heart Failure

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

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.

Study Overview

• Status: Completed
• Conditions: Chagas Cardiomyopathy; Chagas Disease
• Intervention / Treatment: Behavioral: Exercise, nutritional and pharmaceutical counseling

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.

• Study Type: Interventional
• Enrollment (Actual): 12
• Phase: Phase 2; Phase 3

Contacts and Locations

Study Locations

• Brazil
  • RJ
    • Rio de Janeiro, RJ, Brazil, 21040-360
      • Evandro Chagas National Institute of Infectious Disease

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Functional Capacity (VO2 max)	VO2 max (ml/kg/min)	Change from baseline at 4 and 8 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Muscle respiratory strength (maximal inspiratory pressure and maximal expiratory pressure)	Maximal inspiratory pressure and maximal expiratory pressure (cm H2O)	Change from baseline at 4 and 8 months
Body composition (body fat percentage)	Body fat percentage (%)	Change from baseline at 4 and 8 months
Cardiac function (mainly ejection fraction)	Ejection fraction (%)	Change from baseline at 8 months
Biomarkers (lipid profile and glucose)	Total cholesterol, Triacylglycerol, HDL-cholesterol, LDL-cholesterol, VLDL-cholesterol (mg/dl) and glucose (mg/dl)	Change from baseline at 8 months
Biomarkers (glycated hemoglobin)	Glycated hemoglobin (%)	Change from baseline at 8 months
Quality of life by Minnesota Living with heart failure questionnaire (MLHFQ)	MLHFQ Score ranging from 0 to 105	Change from baseline at 8 months
Anthropometry	Body weight (kg)	Change from baseline at 4 and 8 months
Anthropometry	Waist and hip circumference (cm)	Change from baseline at 4 and 8 months

Collaborators and Investigators

• Sponsor: Evandro Chagas National Institute of Infectious Disease
• Investigators: Principal Investigator: Andrea S Sousa, PhD, Evandro Chagas National Institute of Infectious Disease

Study record dates

Study Major Dates

• Study Start: May 1, 2013
• Primary Completion (Actual): January 1, 2014
• Study Completion (Actual): December 1, 2014

Study Registration Dates

• First Submitted: July 31, 2015
• First Submitted That Met QC Criteria: August 3, 2015
• First Posted (Estimate): August 5, 2015

Study Record Updates

• Last Update Posted (Estimate): August 5, 2015
• Last Update Submitted That Met QC Criteria: August 3, 2015
• Last Verified: August 1, 2015

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Heart Diseases; Cardiovascular Diseases; Infections; Vector Borne Diseases; Parasitic Diseases; Protozoan Infections; Trypanosomiasis; Euglenozoa Infections; Heart Failure; Cardiomyopathies; Chagas Cardiomyopathy; Chagas Disease
• Other Study ID Numbers: CAAE 0055.0.009.000-11