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临床试验/NCT02263482
NCT02263482已完成不适用

Inspiratory Muscle and Peripheral Muscle Combined Training Effects on the Respiratory and Functional Capacity and Quality of Life in Chronic Heart Failure

Naomi Kondo Nakagawa2 个研究点 分布在 1 个国家目标入组 30 人开始时间: 2012年10月最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
30
试验地点
2
主要终点
Change in respiratory muscle strength (in centimeters of water)

研究概览

简要总结

Heart failure is a clinical syndrome that is the common end of several cardiac diseases with symptoms such as muscle fatigue, dyspnea and reduction of quality of life. To improve respiratory and general functional capacity of these patients, there are strategies that can be used such as inspiratory muscle training and peripheral muscle training (dynamic resistance training).

详细描述

After agreement with the written informed consent, 35 subjects with severe heart failure were included in this study. They were randomized in three groups: controls, low-intensity and moderate-intensity group. All volunteers were assessed at Baseline and 8-weeks intervention. Cardiac events were registered following two years from baseline. The present study aimed to assess the effects of a combined program of inspiratory and peripheral muscle training on respiratory and general functional capacity and quality of life in patients with chronic heart failure.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Single (Participant)

入排标准

年龄范围
18 Years 至 70 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • chronic heart failure (functional class from NYHA II and III),
  • left ventricle ejection fraction bellow or equal 40%.

排除标准

  • uncontrolled arrhythmia
  • pulmonary edema or pulmonary congestion in the last 30 days
  • peripheral oxygen saturation bellow 92% in resting condition
  • respiratory infection in the previous 30 days to the enrollment into the study
  • cognitive, neurological or orthopedic limitations

研究组 & 干预措施

Control group

Other

patients awaiting for evaluation to cardiac rehabilitation or transplantation

干预措施: control (Other)

moderate-intensity group

Experimental

Patients will be submitted to a 8-weeks training program, with inspiratory muscle trained at 30% of the maximal inspiratory pressure (30 minutes/session/7 days/week) and peripheral muscle trained with upper and lower exercises (50% of the 1-maximum repetition test).

干预措施: moderate-intensity group (Other)

low-intensity group

Active Comparator

Patients will be submited to a 8 weeks training program, with inspiratory muscle trained at 15% of the maximal inspiratory pressure (30 minutes/session/7 days/week) and peripheral muscle trained with exercises of upper limbs and lower limbs (0,5 Kg each).

干预措施: low-intensity group (Other)

结局指标

主要结局

Change in respiratory muscle strength (in centimeters of water)

时间窗: Before and after 8-weeks

Inspiratory and expiratory muscle strength was assessed by using a pressure transducer (MVD-300 Microhard System, GlobalMed, Porto Alegre, Brazil).

次要结局

  • walking distance(Before and after 8-weeks)

研究者

发起方
Naomi Kondo Nakagawa
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

Naomi Kondo Nakagawa

Associate Professor of Medical School of Sao Paulo University

University of Sao Paulo

研究点 (2)

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