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Exercise Training in Chagas Cardiomyopathy

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01006473
First Posted: November 2, 2009
Last Update Posted: August 13, 2015
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Antonio Luiz Pinho Ribeiro, Federal University of Minas Gerais
  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 Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (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 Antonio Luiz Pinho Ribeiro, Federal University of Minas Gerais:

Primary Outcome Measures:
  • Functional capacity [ Time Frame: 12 weeks ]
  • Functional class [ Time Frame: 12 weeks ]
  • Health related quality of life [ Time Frame: 12 weeks ]
  • BNP levels [ Time Frame: 12 weeks ]

Secondary Outcome Measures:
  • Complications related to the exercise training [ Time Frame: 12 weeks ]

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
No Intervention: Inactive control group
No intervention

  Eligibility

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Ages Eligible for Study:   30 Years to 65 Years   (Adult)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

Publications:
Responsible Party: Antonio Luiz Pinho Ribeiro, Professor, Federal University of Minas Gerais
ClinicalTrials.gov Identifier: NCT01006473     History of Changes
Other Study ID Numbers: CNPq402024/2005-2
First Submitted: November 1, 2009
First Posted: November 2, 2009
Last Update Posted: August 13, 2015
Last Verified: August 2015

Keywords provided by Antonio Luiz Pinho Ribeiro, Federal University of Minas Gerais:
Chagas Disease
Chagas Cardiomyopathy
Exercise Movement Techniques

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