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Chagas DiseasePhase 3PEACHNCT02517632

Physical Exercise Program in Chronic Chagas Heart Disease

A Phase 3 study testing Exercise, nutritional and pharmaceutical counceling and Nutritional and pharmaceutical counceling in people with Chagas Disease and Chagas Cardiomyopathy, run by Evandro Chagas National Institute of Infectious Disease at 1 site in Brazil.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Chagas Disease, Chagas Cardiomyopathy
What is being tested?
Exercise, nutritional and pharmaceutical counceling and Nutritional and pharmaceutical counceling
Could I receive a placebo?
No, everyone receives an active treatment
How many people
30 participants
Where
1 siteBrazil
Study dates
Mar 2015to Jan 2017
Phase
Phase 3
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Inclusion Criteria: (1) Chagas disease diagnosis by serology; (2) chronic chagasic cardiomyopathy, with left ventricular ejection fraction <45% or compensated heart failure (3) clinical stability in the last three months, (4) adherence to the ambulatory clinical treatment and (5) age above 18 years.

Exclusion Criteria: (1) pregnancy, (2) neuromuscular limitations, (3) tobacco use, (4) evidence of nonchagasic heart disease, (5) systemic conditions that limits exercise practice or hemodynamic stress tests (6) unavailability to attend three times a week for a minimum of six months, (7) practitioners of regular exercise and (8) claustrophobia.

Trial locations and contacts

1 site in 1 country.

Brazil1 site

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

    Rio de Janeiro, 21040-360

Other trials in Brazil

About this study

Official title: Impact of a Physical Exercise Program in Cardiopulmonary RehAbilitation In Patients With Chronic Chagas Heart Disease: a Randomized Controlled Trial (PEACH Trial)

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.

Read the detailed description

The present study consisted in a randomized clinical study conducted at the Evandro Chagas National Institute of Infectious Disease (INI), located on Rio de Janeiro, Brazil. INI is a national reference center for treatment and research in infectious diseases and tropical medicine in Brazil, which follows a large cohort of patients with Chagas disease, all of them diagnosed by two simultaneously positive serological tests (enzyme-linked immunosorbent assay and indirect immunofluorescence). Patients included in the study are randomly divided in two groups: intervention and control groups. Safety analysis will be performed by monitoring any symptoms presented during data collection and follow-up study.

One of the potential risks that the patient may experience during the study is a noninvasive test that will be performed on a treadmill in a controlled environment, with the possibility of the appearance of symptoms such as fatigue, dyspnea, chest pain, dizziness, with minimal chances of occurring complications of difficult clinical control. Except for the blood test and the cardiopulmonary exercise test, the other tests to be performed are non-invasive and do not bring any risk to the participant's health. Will be collect 10 ml of blood which will be stored for up to five years for biomarker assessments.

During the exercise sessions, patients will be clinically monitored for decompensation, need for hospitalization and suspend or end the participation on the study. All cases will be individually assessed to determine the reversibility of the clinical status. Those cases will continue to be followed by the assistant staff, offering all the clinical support available in INI.

Being tested
Exercise, nutritional and pharmaceutical counceling, Nutritional and pharmaceutical counceling
Keywords
Physical activity, Cardiac rehabilitation
Medical subject headings
Chagas Disease, Chagas Cardiomyopathy, Motor Activity

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Exercise, nutritional and pharmaceutical councelingBehavioural

    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.

  • Nutritional and pharmaceutical councelingBehavioural

    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.

Study groups in NCT02517632
Study groupRoleWhat they receive
Exercise groupExperimentalThis arm will be submitted to a exercise session and counseling from pharmaceutical and nutritional professionals.
Receives: Behavioral: Exercise, nutritional and pharmaceutical counceling
Control groupOtherThis arm will have only the counseling from pharmaceutical and nutritional professionals.
Receives: Behavioral: Nutritional and pharmaceutical counceling

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Functional capacity measured by peak exercise oxygen consumption

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

    Measured: Changes from baselint at three and six months

Secondary outcomes (10)

  1. Muscle respiratory strength

    Maximal inspiratory pressure and maximal expiratory pressure (cmH2O)

    Measured: Changes from baselint at three and six months

  2. Body composition (body fat percentage)

    Measurement of skinfold thickness were taken at the chest, midaxillary, triceps, subscapular, abdomen, suprailiac and thigh sites on the right side of the body while standing in a relaxed position. The sum of these seven skinfold thicknesses was used to estimate body composition by Jackson \& Pollock equation.

    Measured: Changes from baselint at three and six months

  3. Cardiac function (maily ejection fraction)

    Meaured by echocardiography

    Measured: Changes from baselint at three and six months

  4. Laboratorial biomarkers composite

    Total cholesterol, HDL-cholesterol, LDL-cholesterol, VLDL-cholesterol,triacylglycerol, glucose, glycated hemoglobin, inflammatory cytokines, Brain Natriuretic Peptide and components of oxidative stress.

    Measured: Changes from baselint at three and six months

  5. Quality of life

    Minnesota Living with Heart Failure questionnaire (MLHFQ). Score ranging from 0 - 105.

    Measured: Changes from baselint at three and six months

  6. 24 hours Holter

    Cardiac rhythm through continuous dynamic ECG

    Measured: Changes from baselint at three and six months

  7. Nutritional assessment

    By semiquantitative food frequency questionnaire and 24-hour food intake recall.

    Measured: Changes from baselint at three and six months

  8. Pharmaceutical assessment

    Semi-structured questionnaires, Morisky´s test, Naranjo Algorithm.

    Measured: Changes from baselint at three and six months

  9. Microvascular reactivity

    Measured by laser speckle flowmetry

    Measured: Changes from baselint at three and six months

  10. Body mass index

    Measured by the body weight (kg) divided by squared height (in meters).

    Measured: Changes from baselint at three and six months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted7 Aug 2015 (estimated)
  2. Study startMar 2015
  3. Primary completionJan 2017
  4. Study completionJan 2017

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Model description
The intervention group performed exercise sessions, pharmaceutical and nutritional counceling. The control group had only pharmaceutical and nutritional counceling.
Masking
Single blind
Who is masked
Outcomes assessor
Enrolment
30 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02517632
Sponsor's protocol ID
CAAE:38038914.6.0000.5262
Acronym
PEACH
Status last verified
Jul 2017
First submitted
5 Aug 2015
Last updated
27 Jul 2017
Results posted
No
Data monitoring committee
No

Publications

  • 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.

    PubMed 38589582

  • 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.

    PubMed 27590681

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Exercise, nutritional and pharmaceutical counceling and Nutritional and pharmaceutical counceling in people with Chagas Disease and Chagas Cardiomyopathy, run by Evandro Chagas National Institute of Infectious Disease at 1 site in Brazil.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 27 Jul 2017. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Brazil. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Functional capacity measured by peak exercise oxygen consumption (time frame: Changes from baselint at three and six months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02517632, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Jul 2017.

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