Exercise Training in Chagas Cardiomyopathy

NCT01006473 | Completed Phase 4 DMC

• 1 other identifier: CNPq402024/2005-2
• Study Type: interventional
• Target: 37
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Chagas Disease; Cardiomyopathy; Exercise Training

Keywords

Chagas Disease; Chagas Cardiomyopathy; Exercise Movement Techniques

Outcome Measures

Primary Outcomes (4)

• Functional capacity

  12 weeks

• Functional class

  12 weeks

• Health related quality of life

  12 weeks

• BNP levels

  12 weeks

Secondary Outcomes (1)

• Complications related to the exercise training

  12 weeks

Study Arms (2)

Exercise training group

EXPERIMENTAL

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).

Other: Exercise training

Inactive control group

NO INTERVENTION

No intervention

Interventions

Exercise training OTHER

Exercise training group

Eligibility Criteria

• Age: 30 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• Inability to attend regular exercise training
• The presence of a pacemaker, associated cardiac or systemic diseases
• Practitioners of regular physical activity

Sponsors & Collaborators

• Federal University of Minas Gerais: lead

Study Sites (1)

Federal University of Minas Gerais

Belo Horizonte, Minas Gerais, 30130-100, Brazil

Location

Related Publications (4)

• 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.

  PMID: 20675669 RESULT

• 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.

  PMID: 23232458 RESULT

• 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.

  PMID: 20412275 RESULT

• 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.

  PMID: 25098373 RESULT

MeSH Terms

Conditions

Chagas Disease; Cardiomyopathies; Chagas Cardiomyopathy

Interventions

Exercise

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

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

Study Officials

• Antonio L Ribeiro, MD, PhD

  Federal University of Minas Gerais

  STUDY CHAIR

• Manoel Otávio C Rocha, MD, PhD

  Federal University if Minas Gerais

  PRINCIPAL INVESTIGATOR

• Maria do Carmo P Nunes, MD, PhD

  Federal University of Minas Gerais

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: November 1, 2009
• First Posted: November 2, 2009
• Study Start: March 1, 2007
• Primary Completion: March 1, 2008
• Study Completion: March 1, 2009
• Last Updated: August 13, 2015

Record last verified: 2015-08

Locations

BR (1)