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Exercise Training in Chagas Cardiomyopathy

Primary Purpose

Chagas Disease, Cardiomyopathy, Exercise Training

Status
Completed
Phase
Phase 4
Locations
Brazil
Study Type
Interventional
Intervention
Exercise training
Sponsored by
Federal University of Minas Gerais
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Chagas Disease focused on measuring Chagas Disease, Chagas Cardiomyopathy, Exercise Movement Techniques

Eligibility Criteria

30 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Federal University of Minas Gerais

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Exercise training group

Inactive control group

Arm Description

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

Outcomes

Primary Outcome Measures

Functional capacity
Functional class
Health related quality of life
BNP levels

Secondary Outcome Measures

Complications related to the exercise training

Full Information

First Posted
November 1, 2009
Last Updated
August 10, 2015
Sponsor
Federal University of Minas Gerais
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1. Study Identification

Unique Protocol Identification Number
NCT01006473
Brief Title
Exercise Training in Chagas Cardiomyopathy
Official Title
A Randomized Trial of the Effects of Exercise Training in Chagas Cardiomyopathy
Study Type
Interventional

2. Study Status

Record Verification Date
August 2015
Overall Recruitment Status
Completed
Study Start Date
March 2007 (undefined)
Primary Completion Date
March 2008 (Actual)
Study Completion Date
March 2009 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Federal University of Minas Gerais

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chagas Disease, Cardiomyopathy, Exercise Training
Keywords
Chagas Disease, Chagas Cardiomyopathy, Exercise Movement Techniques

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
37 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Exercise training group
Arm Type
Experimental
Arm Description
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).
Arm Title
Inactive control group
Arm Type
No Intervention
Arm Description
No intervention
Intervention Type
Other
Intervention Name(s)
Exercise training
Primary Outcome Measure Information:
Title
Functional capacity
Time Frame
12 weeks
Title
Functional class
Time Frame
12 weeks
Title
Health related quality of life
Time Frame
12 weeks
Title
BNP levels
Time Frame
12 weeks
Secondary Outcome Measure Information:
Title
Complications related to the exercise training
Time Frame
12 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
30 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Antonio L Ribeiro, MD, PhD
Organizational Affiliation
Federal University of Minas Gerais
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Manoel Otávio C Rocha, MD, PhD
Organizational Affiliation
Federal University if Minas Gerais
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Maria do Carmo P Nunes, MD, PhD
Organizational Affiliation
Federal University of Minas Gerais
Official's Role
Study Director
Facility Information:
Facility Name
Federal University of Minas Gerais
City
Belo Horizonte
State/Province
Minas Gerais
ZIP/Postal Code
30130-100
Country
Brazil

12. IPD Sharing Statement

Citations:
PubMed Identifier
20675669
Citation
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.
Results Reference
result
PubMed Identifier
23232458
Citation
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.
Results Reference
result
PubMed Identifier
20412275
Citation
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.
Results Reference
result
PubMed Identifier
25098373
Citation
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.
Results Reference
result

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Exercise Training in Chagas Cardiomyopathy

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