Physical Exercise Program in Chronic Chagas Heart Disease

NCT02517632 | Completed Phase 3

• 1 other identifier: CAAE:38038914.6.0000.5262
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

The aim of this investigation is to evaluate the impact of exercise in a cardiac rehabilitation program on functional capacity, clinical markers, quality of life and biomarkers in patients with chronic chagasic cardiomyopathy.

Conditions

Chagas Disease; Chagas Cardiomyopathy

Keywords

Physical activity; Cardiac rehabilitation

Outcome Measures

Primary Outcomes (1)

• Functional capacity measured by peak exercise oxygen consumption

  This measure is taken during a maximal progressive cardiopulmonary exercise test.

  Changes from baselint at three and six months

Secondary Outcomes (10)

• Muscle respiratory strength

  Changes from baselint at three and six months

• Body composition (body fat percentage)

  Changes from baselint at three and six months

• Cardiac function (maily ejection fraction)

  Changes from baselint at three and six months

• Laboratorial biomarkers composite

  Changes from baselint at three and six months

• Quality of life

  Changes from baselint at three and six months

Study Arms (2)

Exercise group

EXPERIMENTAL

This arm will be submitted to a exercise session and counseling from pharmaceutical and nutritional professionals.

Behavioral: Exercise, nutritional and pharmaceutical counceling

Control group

OTHER

This arm will have only the counseling from pharmaceutical and nutritional professionals.

Behavioral: Nutritional and pharmaceutical counceling

Interventions

Exercise, nutritional and pharmaceutical counceling BEHAVIORAL

The exercise group will be submitted to a physical exercise intervention protocol performed three times per week, 60 minutes per session, during 6-month period, and a monthly counseling from pharmaceutical and nutritional professionals provided during the follow-up and consisted on general guidance about healthy eating habits for patients with heart failure, mainly sodium and water intake, and medication usage, particularly drug dosage and compliance.

Exercise group

Nutritional and pharmaceutical counceling BEHAVIORAL

The control group will be submitted to a monthly counseling from pharmaceutical and nutritional professionals provided during the follow-up and consisted on general guidance about healthy eating habits for patients with heart failure, mainly sodium and water intake, and medication usage, particularly drug dosage and compliance.

Control group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

Sponsors & Collaborators

• Evandro Chagas National Institute of Infectious Disease: lead
• National Institute of Cardiology, Laranjeiras, Brazil: collaborator

Study Sites (1)

Evandro Chagas National Institute of Infectious Diseases, Oswaldo Cruz Foundation.

Rio de Janeiro, 21040-360, Brazil

Location

Related Publications (2)

• Vieira MC, Mendes FSNS, da Silva PS, da Silva GMS, Mazzoli-Rocha F, de Sousa AS, Saraiva RM, de Holanda MT, Kasal DAB, Costa HS, Borges JP, Reis MS, Rodrigues Junior LF, Hasslocher-Moreno AM, do Brasil PEAA, Mediano MFF. Effect of an exercise-based cardiac rehabilitation program on quality of life of patients with chronic Chagas cardiomyopathy: results from the PEACH randomized clinical trial. Sci Rep. 2024 Apr 8;14(1):8208. doi: 10.1038/s41598-024-58776-3.

  PMID: 38589582 DERIVED

• Mendes Fde S, Sousa AS, Souza FC, Pinto VL, Silva PS, Saraiva RM, Xavier SS, Veloso HH, Holanda MT, Costa AR, Carneiro FM, Silva GM, Borges JP, Tibirica E, Pinheiro RO, Lara FA, Hasslocher-Moreno AM, Brasil PE, Mediano MF. Effect of physical exercise training in patients with Chagas heart disease: study protocol for a randomized controlled trial (PEACH study). Trials. 2016 Sep 2;17(1):433. doi: 10.1186/s13063-016-1553-4.

  PMID: 27590681 DERIVED

MeSH Terms

Conditions

Chagas Disease; Chagas Cardiomyopathy; Motor Activity

Interventions

Exercise

Condition Hierarchy (Ancestors)

Trypanosomiasis; Euglenozoa Infections; Protozoan Infections; Parasitic Diseases; Infections; Vector Borne Diseases; Cardiomyopathies; Heart Diseases; Cardiovascular Diseases; Behavior

Intervention Hierarchy (Ancestors)

Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Study Officials

• Fernanda Mendes, M.D.

  Evandro Chagas National Institute of Infectious Disease

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Researcher

Model Details: The intervention group performed exercise sessions, pharmaceutical and nutritional counceling. The control group had only pharmaceutical and nutritional counceling.

Study Record Dates

• First Submitted: August 5, 2015
• First Posted: August 7, 2015
• Study Start: March 1, 2015
• Primary Completion: January 1, 2017
• Study Completion: January 1, 2017
• Last Updated: July 27, 2017

Record last verified: 2017-07

Locations

BR (1)