Cardiac Rehabilitation in Chagas Heart Failure

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Brief Title

Cardiac Rehabilitation in Chagas Heart Failure

Official Title

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

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.
    

Study Phase

Phase 2/Phase 3

Study Type

Interventional


Primary Outcome

Functional Capacity (VO2 max)

Secondary Outcome

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

Condition

Chagas Disease

Intervention

Exercise, nutritional and pharmaceutical counseling

Study Arms / Comparison Groups

 Intervention group
Description:  Physical exercise intervention
Nutritional counseling
Pharmaceutical counseling

Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information


Recruitment Status

Behavioral

Estimated Enrollment

12

Start Date

May 2013

Completion Date

December 2014

Primary Completion Date

January 2014

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.
      

Gender

All

Ages

18 Years - N/A

Accepts Healthy Volunteers

No

Contacts

Andrea S Sousa, PhD, , 

Location Countries

Brazil

Location Countries

Brazil

Administrative Informations


NCT ID

NCT02516293

Organization ID

CAAE 0055.0.009.000-11


Responsible Party

Principal Investigator

Study Sponsor

Evandro Chagas National Institute of Infectious Disease


Study Sponsor

Andrea S Sousa, PhD, Principal Investigator, Evandro Chagas National Institute of Infectious Disease


Verification Date

August 2015