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Inspiratory Muscle and Peripheral Muscle Training in Chronic Heart Failure

2015年12月4日 更新者：Naomi Kondo Nakagawa

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

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).

研究概览

地位

完全的

条件

干预/治疗

详细说明

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.

研究类型

介入性

注册 (实际的)

30

阶段

  • 不适用

联系人和位置

本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。

学习地点

  • 巴西
      • Sao Paulo、巴西、04012-909
        • Instituto Dante Pazzanese de Cardiologia

参与标准

研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

16年 至 68年 (成人、年长者)

接受健康志愿者

不

有资格学习的性别

全部

描述

Inclusion Criteria:

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

Exclusion Criteria:

  • 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

学习计划

本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。

研究是如何设计的？

设计细节

  • 主要用途：治疗
  • 分配：随机化
  • 介入模型：并行分配
  • 屏蔽：单身的

武器和干预

参与者组/臂
干预/治疗
其他：Control group
patients awaiting for evaluation to cardiac rehabilitation or transplantation
其他：control
No intervention during the 8-weeks period of the study because of awaiting evaluation for cardiac rehabilitation or transplantation
实验性的：moderate-intensity group
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).
其他：moderate-intensity group
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) + peripheral muscle trained with exercises of upper limbs and lower limbs (50% 1 RM, increased every 2-weeks).
有源比较器：low-intensity group
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).
其他：low-intensity group
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) + peripheral muscle trained with exercises of upper limbs and lower limbs (0,5 kg each)

研究衡量的是什么？

主要结果指标

结果测量
措施说明
大体时间
Change in respiratory muscle strength (in centimeters of water)
大体时间：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).
Before and after 8-weeks

次要结果测量

结果测量
措施说明
大体时间
walking distance
大体时间：Before and after 8-weeks
To assess functional capacity using walking distance (6-min walk test accordingly to ATS and ERS guidelines)
Before and after 8-weeks

其他结果措施

结果测量
措施说明
大体时间
Change in pulmonary function
大体时间：Before and after 8-weeks
Pulmonary function will be assessed by spirometry.
Before and after 8-weeks
Change in functional capacity
大体时间：Before and after 8-weeks
1RM
Before and after 8-weeks
Inflammation in the upper airway by cytokines in blood
大体时间：Before and after 8-weeks
MMP2, myoglobin, p-selectin, MPO, NGAL, sVCAM, IL-2, IL-3, IL-4, IL-8,MIP1-alpha, 17, VEGF by Multiplex analysis. Inflammatory cells in nasal lavage will be also investigated.
Before and after 8-weeks
Change in heart rate variability (HRV)
大体时间：Before and after 8-weeks
HRV is obtained from the spectral analysis of R-R intervals obtained from a heart rate monitor (Polar, S810, Kempele, Finland)
Before and after 8-weeks
Prevalence of cardiac events and arrhythmia
大体时间：Before and after 8-weeks
by a 24-hours holter system for continuous recording of ambulatory electrocardiographic signs
Before and after 8-weeks
Change in international Physical Activity Questionnaire (IPAQ)
大体时间：Before and after 8-weeks
Patients will be classified as sedentary, irregularly active, active or verry active according to Matsudo's classification (2001).
Before and after 8-weeks
Change in quality of life using Minnesota Questionnaire
大体时间：Before and after 8-weeks

by Short Form-36 and by Minnesota Living with Heart Failure Questionnaire

- Minnesota living with heart failure questionaire: contains 21 questions of physical, social, economic and emotional aspects. Each question ranges from zero to five points, with a total score of 105 points which is the maximum severity degree related to personal perception of quality of life.
Before and after 8-weeks
Change in brain natriuretic peptide (BNP) analysis
大体时间：Before and after 8-weeks
A blood sample of 5 ml will be collected in a tube and BNP measured
Before and after 8-weeks

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

赞助

Naomi Kondo Nakagawa

合作者

Fundação de Amparo à Pesquisa do Estado de São Paulo
Instituto Dante Pazzanese de Cardiologia

调查人员

  • 首席研究员：Naomi K Nakagawa, PhD、USP

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始

2012年10月1日

初级完成 (实际的)

2015年10月1日

研究完成 (实际的)

2015年12月1日

研究注册日期

首次提交

2014年9月29日

首先提交符合 QC 标准的

2014年10月10日

首次发布 (估计)

2014年10月13日

研究记录更新

最后更新发布 (估计)

2015年12月7日

上次提交的符合 QC 标准的更新

2015年12月4日

最后验证

2015年12月1日

更多信息

与本研究相关的术语

关键字

其他相关的 MeSH 术语

其他研究编号

  • CEP 232/12
  • FAPESP 2013/13598-1 (其他赠款/资助编号：FAPESP 2013/13598-1)

此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.

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