MedPath

Exercise Training in Chagas Cardiomyopathy

Phase 4
Completed
Conditions
Chagas Disease
Cardiomyopathy
Exercise Training
Interventions
Other: Exercise training
Registration Number
NCT01006473
Lead Sponsor
Federal University of Minas Gerais
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 available

Recruitment & Eligibility

Status
COMPLETED
Sex
All
Target Recruitment
37
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

Study & Design

Study Type
INTERVENTIONAL
Study Design
PARALLEL
Arm && Interventions
GroupInterventionDescription
Exercise training groupExercise trainingExercise 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).
Primary Outcome Measures
NameTimeMethod
Health related quality of life12 weeks
Functional class12 weeks
Functional capacity12 weeks
BNP levels12 weeks
Secondary Outcome Measures
NameTimeMethod
Complications related to the exercise training12 weeks

Trial Locations

Locations (1)

Federal University of Minas Gerais

🇧🇷

Belo Horizonte, Minas Gerais, Brazil

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