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Exercise Training in Chagas Cardiomyopathy

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ClinicalTrials.gov Identifier: NCT01006473
Recruitment Status : Completed
First Posted : November 1, 2009
Last Update Posted : August 13, 2015
Sponsor:
Information provided by (Responsible Party):
Antonio Luiz Pinho Ribeiro, Federal University of Minas Gerais

Tracking Information
First Submitted Date  ICMJE November 1, 2009
First Posted Date  ICMJE November 1, 2009
Last Update Posted Date August 13, 2015
Study Start Date  ICMJE March 2007
Actual Primary Completion Date March 2008   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: November 1, 2009)
  • 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 ]
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: November 1, 2009)
Complications related to the exercise training [ Time Frame: 12 weeks ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Exercise Training in Chagas Cardiomyopathy
Official Title  ICMJE A Randomized Trial of the Effects of Exercise Training in Chagas Cardiomyopathy
Brief Summary 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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • Chagas Disease
  • Cardiomyopathy
  • Exercise Training
Intervention  ICMJE Other: Exercise training
Study Arms  ICMJE
  • 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).
    Intervention: Other: Exercise training
  • No Intervention: Inactive control group
    No intervention
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: November 1, 2009)
37
Original Actual Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE March 2009
Actual Primary Completion Date March 2008   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 30 Years to 65 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Brazil
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01006473
Other Study ID Numbers  ICMJE CNPq402024/2005-2
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Antonio Luiz Pinho Ribeiro, Federal University of Minas Gerais
Study Sponsor  ICMJE Federal University of Minas Gerais
Collaborators  ICMJE Not Provided
Investigators  ICMJE
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
PRS Account Federal University of Minas Gerais
Verification Date August 2015

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP