- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01006473
Exercise Training in Chagas Cardiomyopathy
August 10, 2015 updated by: Antonio Luiz Pinho Ribeiro, Federal University of Minas Gerais
A Randomized Trial of the Effects of Exercise Training in Chagas Cardiomyopathy
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
37
Phase
- Phase 4
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Minas Gerais
-
Belo Horizonte, Minas Gerais, Brazil, 30130-100
- Federal University of Minas Gerais
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
30 years to 65 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Exercise training group
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).
|
|
No Intervention: Inactive control group
No intervention
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Functional capacity
Time Frame: 12 weeks
|
12 weeks
|
Functional class
Time Frame: 12 weeks
|
12 weeks
|
Health related quality of life
Time Frame: 12 weeks
|
12 weeks
|
BNP levels
Time Frame: 12 weeks
|
12 weeks
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Complications related to the exercise training
Time Frame: 12 weeks
|
12 weeks
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Study Chair: Antonio L Ribeiro, MD, PhD, Federal University of Minas Gerais
- Principal Investigator: Manoel Otávio C Rocha, MD, PhD, Federal University if Minas Gerais
- Study Director: Maria do Carmo P Nunes, MD, PhD, Federal University of Minas Gerais
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- Lima MM, Rocha MO, Nunes MC, Sousa L, Costa HS, Alencar MC, Britto RR, Ribeiro AL. A randomized trial of the effects of exercise training in Chagas cardiomyopathy. Eur J Heart Fail. 2010 Aug;12(8):866-73. doi: 10.1093/eurjhf/hfq123.
- Lima MM, Nunes MC, Nascimento B, Costa HS, Sousa LA, Teixeira AL, Rocha MO, Ribeiro AL. Improvement of the functional capacity is associated with BDNF and autonomic modulation in Chagas disease. Int J Cardiol. 2013 Sep 1;167(5):2363-6. doi: 10.1016/j.ijcard.2012.11.055. Epub 2012 Dec 8. No abstract available.
- Lima MM, Nunes MC, Rocha MO, Beloti FR, Alencar MC, Ribeiro AL. Left ventricular diastolic function and exercise capacity in patients with Chagas cardiomyopathy. Echocardiography. 2010 May;27(5):519-24. doi: 10.1111/j.1540-8175.2009.01081.x. Epub 2010 Apr 16.
- Nascimento BR, Lima MM, Nunes Mdo C, Alencar MC, Costa HS, Pinto Filho MM, Cota VE, Rocha MO, Ribeiro AL. Effects of exercise training on heart rate variability in Chagas heart disease. Arq Bras Cardiol. 2014 Sep;103(3):201-8. doi: 10.5935/abc.20140108. Epub 2014 Aug 1.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
March 1, 2007
Primary Completion (Actual)
March 1, 2008
Study Completion (Actual)
March 1, 2009
Study Registration Dates
First Submitted
November 1, 2009
First Submitted That Met QC Criteria
November 1, 2009
First Posted (Estimate)
November 1, 2009
Study Record Updates
Last Update Posted (Estimate)
August 13, 2015
Last Update Submitted That Met QC Criteria
August 10, 2015
Last Verified
August 1, 2015
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- CNPq402024/2005-2
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Chagas Disease
-
Drugs for Neglected DiseasesLAT ResearchCompletedChagas' DiseaseArgentina
-
Evandro Chagas Institute of Clinical ResearchNot yet recruitingChronic Chagas DiseaseBrazil
-
Drugs for Neglected DiseasesCompletedChagas' Disease (Chronic) NosSpain
-
BayerCompleted
-
Drugs for Neglected DiseasesEisai Co., Ltd.UnknownChronic Chagas Disease, IndeterminateBolivia
-
Juan D. MayaRecruitingChronic Chagas DiseaseChile
-
Institut de Recherche pour le DeveloppementInstituto de Investigación Hospital Universitario La PazCompletedChagas' Disease (Chronic) With Other Organ InvolvementBolivia
-
Drugs for Neglected DiseasesUnknownChagas Disease | Trypanosomiasis, South American | South American Trypanosomiasis | Disease, ChagasBolivia
-
Evandro Chagas National Institute of Infectious...National Institute of Cardiology, Laranjeiras, BrazilCompletedChagas Cardiomyopathy | Chagas DiseaseBrazil
Clinical Trials on Exercise training
-
University of Sao PauloFundação de Amparo à Pesquisa do Estado de São PauloCompleted
-
University of British ColumbiaMichael Smith Foundation for Health ResearchCompleted
-
Universidade Norte do ParanáCompleted
-
University of Colorado, DenverVA Eastern Colorado Health Care SystemCompletedHealthy | Overweight | Type 2 Diabetes Mellitus | Cardiovascular Risk FactorUnited States
-
National Taiwan University HospitalCompletedAtrial FibrillationTaiwan
-
Universita di VeronaRecruiting
-
University of LeipzigCompletedImpact of Intensive Exercise Training on Coronary Collateral Circulation in Patients With Stable CADStable Coronary Artery DiseaseGermany
-
Helse Stavanger HFStavanger Health ResearchCompletedVentricular TachycardiaNorway
-
Toronto Rehabilitation InstituteCompletedAcute Myeloid LeukemiaCanada
-
Hacettepe UniversityCompleted