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Cardiac Rehabilitation in Chagas Heart Failure

Primary Purpose

Chagas Disease, Chagas Cardiomyopathy

Status
Completed
Phase
Phase 2
Locations
Brazil
Study Type
Interventional
Intervention
Exercise, nutritional and pharmaceutical counseling
Sponsored by
Evandro Chagas National Institute of Infectious Disease
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Chagas Disease

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Evandro Chagas National Institute of Infectious Disease

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Intervention group

Arm Description

Physical exercise intervention Nutritional counseling Pharmaceutical counseling

Outcomes

Primary Outcome Measures

Functional Capacity (VO2 max)
VO2 max (ml/kg/min)

Secondary Outcome Measures

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

Full Information

First Posted
July 31, 2015
Last Updated
August 3, 2015
Sponsor
Evandro Chagas National Institute of Infectious Disease
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1. Study Identification

Unique Protocol Identification Number
NCT02516293
Brief Title
Cardiac Rehabilitation in Chagas Heart Failure
Official Title
Cardiac Rehabilitation Program in Patients With Chagas Heart Failure: a Pilot Study
Study Type
Interventional

2. Study Status

Record Verification Date
August 2015
Overall Recruitment Status
Completed
Study Start Date
May 2013 (undefined)
Primary Completion Date
January 2014 (Actual)
Study Completion Date
December 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Evandro Chagas National Institute of Infectious Disease

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chagas Disease, Chagas Cardiomyopathy

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2, Phase 3
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
12 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Intervention group
Arm Type
Experimental
Arm Description
Physical exercise intervention Nutritional counseling Pharmaceutical counseling
Intervention Type
Behavioral
Intervention Name(s)
Exercise, nutritional and pharmaceutical counseling
Intervention Description
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 Measure Information:
Title
Functional Capacity (VO2 max)
Description
VO2 max (ml/kg/min)
Time Frame
Change from baseline at 4 and 8 months
Secondary Outcome Measure Information:
Title
Muscle respiratory strength (maximal inspiratory pressure and maximal expiratory pressure)
Description
Maximal inspiratory pressure and maximal expiratory pressure (cm H2O)
Time Frame
Change from baseline at 4 and 8 months
Title
Body composition (body fat percentage)
Description
Body fat percentage (%)
Time Frame
Change from baseline at 4 and 8 months
Title
Cardiac function (mainly ejection fraction)
Description
Ejection fraction (%)
Time Frame
Change from baseline at 8 months
Title
Biomarkers (lipid profile and glucose)
Description
Total cholesterol, Triacylglycerol, HDL-cholesterol, LDL-cholesterol, VLDL-cholesterol (mg/dl) and glucose (mg/dl)
Time Frame
Change from baseline at 8 months
Title
Biomarkers (glycated hemoglobin)
Description
Glycated hemoglobin (%)
Time Frame
Change from baseline at 8 months
Title
Quality of life by Minnesota Living with heart failure questionnaire (MLHFQ)
Description
MLHFQ Score ranging from 0 to 105
Time Frame
Change from baseline at 8 months
Title
Anthropometry
Description
Body weight (kg)
Time Frame
Change from baseline at 4 and 8 months
Title
Anthropometry
Description
Waist and hip circumference (cm)
Time Frame
Change from baseline at 4 and 8 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Andrea S Sousa, PhD
Organizational Affiliation
Evandro Chagas National Institute of Infectious Disease
Official's Role
Principal Investigator
Facility Information:
Facility Name
Evandro Chagas National Institute of Infectious Disease
City
Rio de Janeiro
State/Province
RJ
ZIP/Postal Code
21040-360
Country
Brazil

12. IPD Sharing Statement

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Cardiac Rehabilitation in Chagas Heart Failure

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