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临床试验/NCT02516293
NCT02516293已完成2 期

Cardiac Rehabilitation Program in Patients With Chagas Heart Failure: a Pilot Study

Evandro Chagas National Institute of Infectious Disease2 个研究点 分布在 1 个国家目标入组 12 人开始时间: 2013年5月1日最近更新:
适应症

试验速览

阶段
2 期
状态
已完成
发起方
入组人数
12
试验地点
2
主要终点
Functional Capacity (VO2 max)

研究概览

简要总结

Due to the lack of information in the literature about the role of cardiac rehabilitation on Chagas heart failure, the aim of the present study was to evaluate the effects of a cardiac exercise program on functional capacity, cardiac function, respiratory muscle strength, body composition, biomarkers and quality of life among Chagas heart failure patients.

详细描述

The present study consisted in a pre/post single-arm intervention study conducted at the Evandro Chagas National Institute of Infectious Disease (INI), located on Rio de Janeiro, Brazil. INI is a national reference center for treatment and research in infectious diseases and tropical medicine in Brazil, which follows a large cohort of patients with Chagas disease, all of them diagnosed by two simultaneously positive serological tests (enzyme-linked immunosorbent assay and indirect immunofluorescence). Patients included in the study were submitted to a physical exercise intervention protocol performed three times per week, 60 minutes per session, during an 8-month period. Nutritional and pharmaceutical counseling were also monthly provided during the follow-up and consisted on general guidance about adequate eating habits for patients with heart failure, mainly sodium and water intake, and medication usage, particularly drug dosage and compliance.Patients included in the study were followed during an 8-month period in which evaluations of functional capacity (maximal progressive cardiopulmonary exercise test), muscle respiratory strength (manovacuometry) and body composition (anthropometry and skinfolds) were performed at baseline, after four months and at the end of follow-up. Assessments of cardiac function (bidimensional echocardiography), biomarkers (lipid profile, glucose and glycated hemoglobin) and quality of life (Minnesota Living with Heart Failure questionnaire) were taken at baseline and after eight months of follow-up.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Treatment
盲法
None

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Patients at the stages C or D of Chagas cardiomyopathy
  • Patients receiving standard optimized medical therapy
  • Patients with good adherence to outpatient treatment within the last three months.

排除标准

  • Those who were not able to attend three weekly training sessions,
  • Those who had neuromuscular limitations, cardiopathies from non-Chagasic etiology (e.g ischemic), systemic conditions that limits exercise practice (e.g chronic obstructive pulmonary disease)
  • Practitioners of regular exercise.

结局指标

主要结局

Functional Capacity (VO2 max)

时间窗: Change from baseline at 4 and 8 months

VO2 max (ml/kg/min)

次要结局

  • Muscle respiratory strength (maximal inspiratory pressure and maximal expiratory pressure)(Change from baseline at 4 and 8 months)
  • Body composition (body fat percentage)(Change from baseline at 4 and 8 months)
  • Cardiac function (mainly ejection fraction)(Change from baseline at 8 months)
  • Biomarkers (lipid profile and glucose)(Change from baseline at 8 months)
  • Biomarkers (glycated hemoglobin)(Change from baseline at 8 months)
  • Quality of life by Minnesota Living with heart failure questionnaire (MLHFQ)(Change from baseline at 8 months)
  • Anthropometry(Change from baseline at 4 and 8 months)

研究者

发起方
Evandro Chagas National Institute of Infectious Disease
申办方类型
Other
责任方
Principal Investigator
主要研究者

Mauro Felippe Felix Mediano

Clinical Researcher in Public Health

Evandro Chagas National Institute of Infectious Disease

研究点 (2)

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