Cardiac Rehabilitation in Chagas Heart Failure

NCT02516293 | Completed Phase 2

• 1 other identifier: CAAE 0055.0.009.000-11
• Study Type: interventional
• Target: 12
• Locations: 1 country
• Sites: 1

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.

Conditions

Chagas Disease; Chagas Cardiomyopathy

Outcome Measures

Primary Outcomes (1)

• Functional Capacity (VO2 max)

  VO2 max (ml/kg/min)

  Change from baseline at 4 and 8 months

Secondary Outcomes (8)

• Muscle respiratory strength (maximal inspiratory pressure and maximal expiratory pressure)

  Change from baseline at 4 and 8 months

• Body composition (body fat percentage)

  Change from baseline at 4 and 8 months

• Cardiac function (mainly ejection fraction)

  Change from baseline at 8 months

• Biomarkers (lipid profile and glucose)

  Change from baseline at 8 months

• Biomarkers (glycated hemoglobin)

  Change from baseline at 8 months

Study Arms (1)

Intervention group

EXPERIMENTAL

* Physical exercise intervention * Nutritional counseling * Pharmaceutical counseling

Behavioral: Exercise, nutritional and pharmaceutical counseling

Interventions

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.

Intervention group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Evandro Chagas National Institute of Infectious Disease: lead

Study Sites (1)

Evandro Chagas National Institute of Infectious Disease

Rio de Janeiro, Rio de Janeiro, 21040-360, Brazil

Location

MeSH Terms

Conditions

Chagas Disease; Chagas Cardiomyopathy

Interventions

Exercise

Condition Hierarchy (Ancestors)

Trypanosomiasis; Euglenozoa Infections; Protozoan Infections; Parasitic Diseases; Infections; Vector Borne Diseases; Cardiomyopathies; Heart Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Study Officials

• Andrea S Sousa, PhD

  Evandro Chagas National Institute of Infectious Disease

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical Researcher in Public Health

Study Record Dates

• First Submitted: July 31, 2015
• First Posted: August 5, 2015
• Study Start: May 1, 2013
• Primary Completion: January 1, 2014
• Study Completion: December 1, 2014
• Last Updated: August 5, 2015

Record last verified: 2015-08

Locations

BR (1)