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临床试验/NCT02270346
NCT02270346已完成不适用

Effects of Inspiratory Muscle Training in Allogeneic Hematopoietic Stem Cell Transplantation Recipients

Gazi University0 个研究点目标入组 40 人开始时间: 2012年3月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
40
主要终点
Inspiratory and expiratory muscle strength (MIP, MEP)

研究概览

简要总结

Allogeneic hematopoietic stem cell transplantation (allo-HSCT) causes various toxic effects in many body tissues, organs and systems such as immune, cardiovascular, pulmonary, gastrointestinal, neuroendocrine and musculoskeletal systems, liver, kidneys and skin.Available limited numbers of studies showed that inspiratory muscle weakness in allo-HSCT candidates and recipients. Although meta-analysis, systematic reviews and studies demonstrated beneficial effects of inspiratory muscle training on several outcomes in different disease groups; chronic obstructive pulmonary disease, bronchiectasis and heart failure, no published paper reported the effects of IMT in allo-HSC recipients.

详细描述

Thirty-eight allo-HSCT recipients (˃100 days past post-transplant status) were included. Before and after 6-week IMT, maximal and submaximal exercise capacity, respiratory and peripheral muscle strength, pulmonary functions, dyspnea and fatigue perception, depression and quality of life were evaluated. Primary outcome measurement was respiratory muscle strength, secondary outcomes were exercise capacity, dyspnea, peripheral muscle strength, quality of life, fatigue and depression.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Supportive Care
盲法
Triple (Participant, Investigator, Outcomes Assessor)

入排标准

年龄范围
18 Years 至 65 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Allo-HSC recipients (˃100 days past post-transplant status),
  • 18-65 years of age,
  • Under standard medications

排除标准

  • Having cognitive disorder, orthopedic problem or neurological disease that were affecting functional capacity,
  • Additional heart and lung diseases such as asthma, chronic obstructive pulmonary disease, acute infections or pneumonia,
  • Problems prevented performing assessment and training such as visual problems and mucositis

结局指标

主要结局

Inspiratory and expiratory muscle strength (MIP, MEP)

时间窗: 6 weeks

Mouth pressure device

次要结局

  • Peripheral muscle strength(6 weeks)
  • Depression(6 weeks)
  • Submaximal exercise capacity(6 weeks)
  • Pulmonary function(6 weeks)
  • Maximal exercise capacity(6 weeks)
  • Fatigue(6 weeks)
  • Dyspnea(6 weeks)
  • Quality of life(6 weeks)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Meral Boşnak Güçlü

Assoc. Prof.

Gazi University

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