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Determining factors of prognosis and morbidity in Chronic Chagas Heart Disease - phase III

Determining factors of prognosis and morbidity in Chronic Chagas Heart Disease - phase III - DCHD: Dilated Chagasic Heart Disease

Status
Recruiting
Phases
Phase 3
Study type
Interventional
Source
REBEC
Registry ID
RBR-9gm9bz
Enrollment
Unknown
Registered
2020-06-12
Start date
2020-02-03
Completion date
Unknown
Last updated
2025-10-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cardiovascular diseases

Interventions

Experimental group: 15 volunteers (male or female) diagnosed with Chagas 'disease with Chagas' dilated cardiomyopathy and inspiratory muscle weakness. They will perform inspiratory muscle training for
Device
Behavioural
Other
E02.760.169.063.500.387
G11.427.410.698.277.311

Sponsors

Universidade Federal de Minas Gerais
Lead Sponsor
Universidade Federal de Minas Gerais
Collaborator

Eligibility

Age
30 Years to 60 Years

Inclusion criteria

Inclusion criteria: Diagnosis of Chagas disease by at least two of the three positive serological tests for Trypanosoma cruzi (indirect immunofluorescence, indirect hemoglutination and ELISA). Present a stable clinical condition, defined as no acute exacerbation of heart disease in the last three months. Presence of cardiac involvement defined, on echocardiogram, by the presence of left ventricular dysfunction (ejection fraction lower 52% for males and 54% for females). Presence of clinical signs and symptoms of heart failure (NYHA II and III). Not being a smoker and denying routine exposure to smoking Presence of inspiratory muscle weakness defined with maximum inspiratory pressure values lower 70% of predicted. Be aged between 30 and 60 years. Be sedentary according to the International Physical Activity Questionnaire (IPAQ). Not having previous episodes of stroke and not having pulmonary, renal pathologies, musculoskeletal limitations and diabetes mellitus, conditions that alter the ability to perform functional tests.

Exclusion criteria

Exclusion criteria: Warm-up activities before carrying out stress tests as well as any other contraindications to the maximum and submaximal tests. Failure to perform the study's evaluation procedures. Only for the experimental group: do not perform inspiratory muscle training for two days in the same week (at home) or are absent from two supervised sessions during training.

Design outcomes

Primary

MeasureTime frame
Improvement of post-intervention cardiorespiratory capacity, as assessed by the cardiopulmonary stress test.;Increased post-intervention inspiratory muscle strength, assessed by manovacuometry.;Increase in the distance covered by the 6-minute walk test by at least 50 meters.;Improved perception of quality of life, as assessed by the SF-36 and MLwHFQ questionnaires.;Improvement of dyspnea during their activities of daily living, assessed by the MRC instrument.

Secondary

MeasureTime frame
Check the adherence rate of the sessions during the weeks of inspiratory muscle training, through presence at the clinic and follow-up booklet.;Monitor adverse events such as hospitalization, stroke and death monthly after twelve weeks of supervised telephone contact.

Countries

Brazil

Contacts

Public ContactManoel Rocha

Faculade de Medicina da UFMG

rochamoc@terra.com.br+553134099641

Outcome results

None listed

Source: REBEC (via WHO ICTRP)