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Effect of physical exercise performed at home on people with the indeterminate form of Chagas disease

Home-based physical exercise program in the indeterminate form of Chagas Disease (PEDI-CHAGAS STUDY): A randomized clinical trial

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
REBEC
Registry ID
RBR-10yxgcr9
Enrollment
Unknown
Registered
2021-01-12
Start date
2023-06-01
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

Depression

Interventions

This is a two-arm, double-blind, randomized controlled clinical trial. The intervention will last for six months. Each of the control and intervention groups will consist of 40 volunteers with the und
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Sponsors

Instituto Nacional de Infectologia Evandro Chagas - Fundação Oswaldo Cruz
Lead Sponsor
Instituto Nacional de Infectologia Evandro Chagas - Fundação Oswaldo Cruz
Collaborator

Eligibility

Age
18 Years to No maximum

Inclusion criteria

Inclusion criteria: Serological positivity for Chagas disease; both sexes; absence of symptoms and or clinical signs of cardiac and / or digestive disorders associated with Chagas disease.

Exclusion criteria

Exclusion criteria: Age below 18 years; cardiopathies of non-chagasic etiology; osteomioarticular changes that make it impossible to perform the physical exercise protocol; clinical contraindication for physical exercise; regular physical exercise in the last 2 months.

Design outcomes

Primary

MeasureTime frame
Evaluate the effect of a home based physical exercise program in patients with the chronic indeterminate form of Chagas disease in cardiorespiratory fitness that will be assessed using the cardiopulmonary stress test;Evaluate the effect of a home based physical exercise program in patients with the chronic indeterminate form of Chagas disease in flexibility, which will be assessed using the sit and reach test;Evaluate the effect of a home based physical exercise program on patients with chronic indeterminate form of Chagas disease in strength using manual dynamometry;Evaluate the effect of a home based physical exercise program on patients with the chronic indeterminate form of Chagas disease in Quality of Life, using the World Health Organization's abbreviated quality of life assessment instrument, validated for use in the population the WHOQOL-Bref;Evaluate the effect of a home based exercise program on patients with the chronic indeterminate form of Chagas disease in the symptoms of depression using the Beck Depression Inventory;Evaluate the effect of a home based physical exercise program on patients with the indeterminate chronic form of Chagas disease in anxiety symptoms using the Beck Anxiety Inventory;Evaluate the effect of a home based physical exercise program on patients with an undetermined chronic form of Chagas disease under stress, using the validated perception stress scale (PSS);Evaluate the effect of a home based physical exercise program on patients with an undetermined chronic form of Chagas disease on nutritional status through anthropometric measurements and body composition;Evaluate the effect of a home based physical exercise program on patients with an undetermined chronic form of Chagas disease on sleep quality, using the Pittsburgh Sleep Quality Index;Evaluate the effect of a home based physical exercise program on patients with an undetermined chronic form of Chagas disease on biomarkers of lipid, inflammatory and cardiac function profile

Secondary

MeasureTime frame
Secondary outcomes are not expected

Countries

Brazil

Contacts

Public ContactMauro Felippe Mediano

Instituto Nacional de Infectologia Evandro Chagas - Fundação Oswaldo Cruz

mffmediano@gmail.com55 21 985210609

Outcome results

None listed

Source: REBEC (via WHO ICTRP) · Data processed: Feb 10, 2026