Exercise Training in Chagas Cardiomyopathy

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

37 participants

Study Classification

INTERVENTIONAL

Study Start Date

2007-03-31

Study Completion Date

2009-03-31

Brief Summary

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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.

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Detailed Description

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Conditions

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Chagas Disease Cardiomyopathy Exercise Training

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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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).

Group Type EXPERIMENTAL

Exercise training

Intervention Type OTHER

Inactive control group

No intervention

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Exercise training

Intervention Type OTHER

Eligibility Criteria

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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

Minimum Eligible Age

30 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No