Exercise Training in Chagas Cardiomyopathy

This study has been completed.

Sponsor:

Information provided by:

Federal University of Minas Gerais

ClinicalTrials.gov Identifier:

NCT01006473

First received: November 1, 2009

Last updated: NA

Last verified: November 2009

History: No changes posted

Tracking Information

First Received Date ^ICMJE

November 1, 2009

Last Updated Date

November 1, 2009

Start Date ^ICMJE

March 2007

Primary Completion Date

March 2008 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

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 ]

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

No Changes Posted

Current Secondary Outcome Measures ^ICMJE

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

Original Secondary Outcome Measures ^ICMJE

Same as current

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

Exercise Training in Chagas Cardiomyopathy

Official Title ^ICMJE

A Randomized Trial of the Effects of Exercise Training in Chagas Cardiomyopathy

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.

Detailed Description

Not Provided

Study Type ^ICMJE

Interventional

Study Phase

Phase 4

Study Design ^ICMJE

Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment

Condition ^ICMJE

Chagas Disease
Cardiomyopathy
Exercise Training

Intervention ^ICMJE

Other: Exercise training
Other Name: Exercise training
Procedure: Control

Study Arm (s)

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).

Intervention: Other: Exercise training
No Intervention: Inactive control group
No intervention

Intervention: Procedure: Control

Publications *

Not Provided

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Enrollment ^ICMJE

Completion Date

March 2009

Primary Completion Date

March 2008 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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

Gender

Both

Ages

30 Years to 65 Years

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

Brazil

Administrative Information

NCT Number ^ICMJE

NCT01006473

Other Study ID Numbers ^ICMJE

CNPq402024/2005-2

Has Data Monitoring Committee

Yes

Responsible Party

Antonio Luiz Pinho Ribeiro, Federal University of Minas Gerais

Study Sponsor ^ICMJE

Federal University of Minas Gerais

Collaborators ^ICMJE

Not Provided

Investigators ^ICMJE

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

Information Provided By

Federal University of Minas Gerais

Verification Date

November 2009

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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