Exercise Training in Chagas Cardiomyopathy

This study has been completed.
Sponsor:
Information provided by:
Federal University of Minas Gerais
ClinicalTrials.gov Identifier:
NCT01006473
First received: November 1, 2009
Last updated: NA
Last verified: November 2009
History: No changes posted
  Purpose

The benefits of exercise training in heart failure are well established. Its effects, however, have not been evaluated in Chagas cardiomyopathy (ChC). The investigators hypothesis is that the exercise training may improve functional capacity, quality of life (QoL), and reduce brain natriuretic peptide (BNP) levels in patients with ChC.


Condition Intervention Phase
Chagas Disease
Cardiomyopathy
Exercise Training
Other: Exercise training
Procedure: Control
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Randomized Trial of the Effects of Exercise Training in Chagas Cardiomyopathy

Resource links provided by NLM:


Further study details as provided by Federal University of Minas Gerais:

Primary Outcome Measures:
  • Functional capacity [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
  • Functional class [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
  • Health related quality of life [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
  • BNP levels [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Complications related to the exercise training [ Time Frame: 12 weeks ] [ Designated as safety issue: Yes ]

Enrollment: 37
Study Start Date: March 2007
Study Completion Date: March 2009
Primary Completion Date: March 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Exercise training group
Exercise training is performed in subgroups of 6 patients supervised by two physiotherapists. Exercise prescription consisted of a 15-min warm-up, walking up to 30 min, followed by a 15-min cooling-down. The exercise intensity during the first 2 weeks corresponds to 55% at 65% of the HR peak reached at the baseline exercise test. In posterior sessions, individual adjustments are performed with gradual increases in order to reach the adequate target HR training intensity, as determined by the Karvonen formula {(maximal HR - HR at rest) x 50 to 70% + HR at rest}. Exercise training is performed in the morning, three times a week (on alternate days) for a total of 12 weeks (36 sessions).
Other: Exercise training
Other Name: Exercise training
No Intervention: Inactive control group
No intervention
Procedure: Control

  Eligibility

Ages Eligible for Study:   30 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Chronic Chagas dilated cardiomyopathy, defined by the echocardiography finding of a dilated left ventricle with moderate or severe impaired left ventricular systolic function (left ventricular ejection fraction ≤ 45%).
  • To be clinically stable for at least 3 months
  • To have sinus rhythm
  • To be under standard medical therapy use at the time.

Exclusion Criteria:

  • Inability to attend regular exercise training
  • The presence of a pacemaker, associated cardiac or systemic diseases
  • Practitioners of regular physical activity
  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT01006473

Locations
Brazil
Federal University of Minas Gerais
Belo Horizonte, Minas Gerais, Brazil, 30130-100
Sponsors and Collaborators
Federal University of Minas Gerais
Investigators
Study Chair: Antonio L Ribeiro, MD, PhD Federal University of Minas Gerais
Principal Investigator: Manoel Otávio C Rocha, MD, PhD Federal University if Minas Gerais
Study Director: Maria do Carmo P Nunes, MD, PhD Federal University of Minas Gerais
  More Information

No publications provided

Responsible Party: Antonio Luiz Pinho Ribeiro, Federal University of Minas Gerais
ClinicalTrials.gov Identifier: NCT01006473     History of Changes
Other Study ID Numbers: CNPq402024/2005-2
Study First Received: November 1, 2009
Last Updated: November 1, 2009
Health Authority: Brazil: National Committee of Ethics in Research

Keywords provided by Federal University of Minas Gerais:
Chagas Disease
Chagas Cardiomyopathy
Exercise Movement Techniques

Additional relevant MeSH terms:
Cardiomyopathies
Chagas Cardiomyopathy
Chagas Disease
Cardiovascular Diseases
Euglenozoa Infections
Heart Diseases
Parasitic Diseases
Protozoan Infections
Trypanosomiasis

ClinicalTrials.gov processed this record on October 21, 2014