Exercise Training in Chagas Cardiomyopathy

Federal University of Minas Gerais

Status and phase: Completed; Phase 4

Conditions: Cardiomyopathy; Exercise Training; Chagas Disease

Treatments: Other: Exercise training

Study type: Interventional

Funder types: Other

Identifiers

NCT01006473

CNPq402024/2005-2

Details and patient eligibility

About

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.

Enrollment: 37 patients

Sex: All

Ages: 30 to 65 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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37 participants in 2 patient groups

Exercise training group

Experimental group

Description:

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).

Treatment:

Other: Exercise training

Inactive control group

No Intervention group

Description:

No intervention