NCT01006473|CompletedPhase 4DMC
Exercise Training in Chagas Cardiomyopathy
A Randomized Trial of the Effects of Exercise Training in Chagas Cardiomyopathy
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Sponsor study identifier
interventional
37
1 country
1
Study Start
March 2007
Date type not reportedThis date has not been verified as actual or estimated.
Primary Completion
March 2008
Actual (reported)Study Completion
March 2009
Actual (reported)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.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
March 2009
Actual (reported)Click on a node to explore related trials.
Some registry-reported names shown below are not yet linked in this graph.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
March 2007
Date type not reportedThis date has not been verified as actual or estimated.
March 2008
Actual (reported)March 2009
Actual (reported)November 1, 2009
Actual (reported)November 2, 2009
Actual (reported)Functional capacity
12 weeks
Functional class
12 weeks
Health related quality of life
12 weeks
BNP levels
12 weeks
Complications related to the exercise training
12 weeks
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
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
Federal University of Minas Gerais
Belo Horizonte, Minas Gerais, 30130-100, Brazil
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.
Antonio L Ribeiro, MD, PhD
Federal University of Minas Gerais
Manoel Otávio C Rocha, MD, PhD
Federal University if Minas Gerais
Maria do Carmo P Nunes, MD, PhD
Federal University of Minas Gerais
37 participants (actual enrollment reported by the registry).
First Submitted
November 1, 2009
First Posted
November 2, 2009
Study Start
March 2007
Date type not reportedThis date has not been verified as actual or estimated.
Contact the study team to confirm eligibility.
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.
Primary Completion
March 2008
Actual (reported)Study Completion
March 2009
Actual (reported)Last Updated
August 13, 2015
Record last verified: 2015-08
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Source: ClinicalTrials.gov.
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