Exercise Training in Chagas Cardiomyopathy - Full Text View

Purpose

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.

Condition	Intervention	Phase
Chagas Disease Cardiomyopathy Exercise Training	Other: Exercise training Procedure: Control	Phase 4

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment
Official Title:	A Randomized Trial of the Effects of Exercise Training in Chagas Cardiomyopathy

Resource links provided by NLM:

MedlinePlus related topics: Cardiomyopathy Chagas Disease Exercise and Physical Fitness

U.S. FDA Resources

Further study details as provided by Federal University of Minas Gerais:

Primary Outcome Measures:

Functional capacity [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
Functional class [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
Health related quality of life [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
BNP levels [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Complications related to the exercise training [ Time Frame: 12 weeks ] [ Designated as safety issue: Yes ]

Enrollment:	37
Study Start Date:	March 2007
Study Completion Date:	March 2009
Primary Completion Date:	March 2008 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
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).	Other: Exercise training Other Name: Exercise training
No Intervention: Inactive control group No intervention	Procedure: Control

Arms

Assigned Interventions

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).

Other: Exercise training

Other Name: Exercise training

No Intervention: Inactive control group

No intervention

Procedure: Control

Eligibility

Ages Eligible for Study:	30 Years to 65 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT01006473

Locations

Brazil
Federal University of Minas Gerais
Belo Horizonte, Minas Gerais, Brazil, 30130-100

Sponsors and Collaborators

Federal University of Minas Gerais

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

More Information

No publications provided

Responsible Party:	Antonio Luiz Pinho Ribeiro, Federal University of Minas Gerais
ClinicalTrials.gov Identifier:	NCT01006473 History of Changes
Other Study ID Numbers:	CNPq402024/2005-2
Study First Received:	November 1, 2009
Last Updated:	November 1, 2009
Health Authority:	Brazil: National Committee of Ethics in Research

Keywords provided by Federal University of Minas Gerais:

Chagas Disease
Chagas Cardiomyopathy
Exercise Movement Techniques

Additional relevant MeSH terms:

Chagas Cardiomyopathy
Chagas Disease
Cardiomyopathies
Trypanosomiasis
Euglenozoa Infections

Protozoan Infections
Parasitic Diseases
Heart Diseases
Cardiovascular Diseases

ClinicalTrials.gov processed this record on June 17, 2013