Exercise Training in Chagas Cardiomyopathy

Study Overview
=================
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.

Official Title
-----------------
A Randomized Trial of the Effects of Exercise Training in Chagas Cardiomyopathy

Conditions
-----------------
Chagas Disease, Cardiomyopathy, Exercise Training

Intervention / Treatment
-----------------
* Other: Exercise training


Participation Criteria
=================
Eligibility 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

Ages Eligible for Study
-----------------
Minimum Age: 30 Years
Maximum Age: 65 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Exercise training group<br>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<br> <br> |
| No Intervention: Inactive control group<br>No intervention | |

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Functional capacity |  | 12 weeks | 
| Functional class |  | 12 weeks | 
| Health related quality of life |  | 12 weeks | 
| BNP levels |  | 12 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Complications related to the exercise training |  | 12 weeks | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Chagas Disease, Chagas Cardiomyopathy, Exercise Movement Techniques