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临床试验/NCT03511287
NCT03511287已完成不适用

Effects of Inspiratory Muscle Training in Inspiratory Muscle Function, Functional Capacity, Quality of Life, Lung Function, Breathing Pattern and Thoracoabdominal Motion in Patients With Advanced Lung Disease

Federal University of Minas Gerais4 个研究点 分布在 1 个国家目标入组 22 人开始时间: 2015年6月1日最近更新:
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
22
试验地点
4
主要终点
Change in Inspiratory Muscle Endurance

研究概览

简要总结

The aim of this clinical trial is to evaluate, the effects of inspiratory muscle training program in inspiratory muscle function, functional capacity, quality of life, lung function, breathing pattern and chest wall motion in patients with advanced lung disease. Patients were evaluated before the inspiratory muscle training, after 8 weeks of training and at follow-up which was performed 3 months after the end of the intervention.

详细描述

Inspiratory Muscle Training (IMT) should be considered an additional intervention in the pulmonary rehabilitation program for patients with advanced lung disease. The aim of this study is to evaluate, the effects of inspiratory muscle training program in inspiratory muscle function, functional capacity, quality of life, lung function, breathing pattern and chest wall motion in patients with advanced lung disease. It is a quasi-experimental study with longitudinal design. Patients with advanced lung disease from the advanced lung disease and pre lung transplantation ambulatory performed home-based high intensity interval IMT for 8 weeks (two sessions per day, daily). In each session patients executed two times 30 breaths with one-minute rest between them. Resistance was set to the highest tolerable according to scores pointed by the patient on the Borg score (between 4 and 6) aiming 50% of actual pimax or higher. An experienced physiotherapist was responsible for weekly adjustments on the resistance of training as well as new assessment of maximal inspiratory pressure. Patients were evaluated before the inspiratory muscle training, after 8 weeks of training and at follow-up which was performed 3 months after the end of the intervention. Patients were evaluated by the same experienced researcher in all three moments of the study. Evaluations were performed in the Laboratory of research and evaluation of cardiorespiratory performance of Federal University of Minas Gerais.

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

  • presence of inspiratory muscle weakness (Maximal Inspiratory Pressure - MIP ≤ 60 cmH2O or below the reference values proposed for the Brazilian population.
  • completion of a 36 sessions of PR or nonattendance in any pulmonary rehabilitation by the time of inclusion and no perspective of initiating it in the next 8 weeks.
  • absence of pre-existing neuromuscular, infectious, metabolic, psychiatric diseases or orthopedic problems that prevent from activities of daily living.

排除标准

  • presented inspiratory muscle strength higher than 60 cmH2O or predicted value
  • unable to follow commands related to the measurements or to the IMT

研究组 & 干预措施

IMT group

Experimental

Group intervention: home-based interval inspiratory muscle training:

  • during 8 weeks (two sessions per day, daily)
  • two times 30 breaths with one-minute rest between them in each session
  • training resistance set to the highest tolerable load according to scores pointed by the patient on the Borg score (between 4 and 6) aiming 50% of actual pimax or higher adjusted in the supervised weekly session

干预措施: Inspiratory Muscle Training (Other)

结局指标

主要结局

Change in Inspiratory Muscle Endurance

时间窗: Before intervention, after 8 weeks intervention and follow-up (3 months after the end of intervention)

Inspiratory endurance time in seconds

Change in Inspiratory muscle strength

时间窗: Before intervention, after 8 weeks intervention and follow-up (3 months after the end of intervention)

Maximal inspiratory pressure in cmH2O

次要结局

  • Change in Lung Function(Before intervention, after 8 weeks intervention and follow-up (3 months after the end of intervention))
  • Change in Functional Capacity (direct measure)(Before intervention, after 8 weeks intervention and follow-up (3 months after the end of intervention))
  • Change in Functional Capacity (inderect measure)(Before intervention, after 8 weeks intervention and follow-up (3 months after the end of intervention))
  • Quality of life(Before intervention, after 8 weeks intervention and follow-up (3 months after the end of intervention))
  • Change in Breathing pattern(Before intervention, after 8 weeks intervention and follow-up (3 months after the end of intervention))
  • Change in chest wall motion(Before intervention, after 8 weeks intervention and follow-up (3 months after the end of intervention))

研究者

发起方
Federal University of Minas Gerais
申办方类型
Other
责任方
Principal Investigator
主要研究者

Veronica Franco Parreira

Full Professor

Federal University of Minas Gerais

研究点 (4)

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