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临床试验/NCT06070831
NCT06070831尚未招募不适用

Comparison Between Two Respiratory Muscle Training Protocols: Inspiratory Muscle Training vs Expiratory Muscle Training in Acquired Brain Injury Patients.

University of Salamanca0 个研究点目标入组 26 人开始时间: 2023年12月21日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
尚未招募
入组人数
26
主要终点
Inspiratory muscle strength

研究概览

简要总结

Background: Respiratory health problems are one of the main causes of morbidity and mortality in adult people with acquired brain injury (ABI). The influence of respiratory muscle training has not yet been studied in this population group. The objective of the study was to evaluate and compare the efficacy of two protocols with respiratory muscle training, inspiratory muscle training vs expiratory muscle training, to improve respiratory strength and pulmonary function in adults with CP.

Methods: The study is a controlled, randomised, double-blind trial and with allocation concealment. 26 ABI patients will be recruited and randomly distributed in the inspiratory muscle training group (IMT) and the expiratory muscle training group (EMT). Over an 8-week period an IMT or EMT protocol was followed 5 days/week, 5 series of 1-minute with 1-minute rest between them. IMT trained with a load of 50% of the maximum inspiratory pressure (MIP) and EMT with 50% of the maximum expiratory pressure (MEP). Respiratory strength and pulmonary function were evaluated.

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
Triple (Participant, Care Provider, Investigator)

盲法说明

The professional that collected the data and the participants were unaware of group assignment.

入排标准

性别
All
接受健康志愿者
否

入选标准

  • •Belong to ASDACE.
  • •Sign the Informed consent.

排除标准

  • •The presence of a respiratory disease in the previous month, inability to understand assessment tests or intervention or hemodynamic alterations (heart rate > 150 beats per minute (bpm), systolic blood pressure > 140 millimeters mercury (mmHg) or diastolic blood pressure > 90 mmHg).

研究组 & 干预措施

Inspiratory muscle training group (IMT)

Experimental

Inspiratory muscle training at 50% of MIP, the training load was set each 2 weeks to keep 50% of MIP.

干预措施: Inspiratory muscle training (Device)

Expiratory muscle training group (EMT)

Experimental

Expiratory muscle training at 50% of MEP, following the same rules as HIT.

干预措施: Expiratory muscle training (Device)

结局指标

主要结局

Inspiratory muscle strength

时间窗: 8 weeks.

It was measured using the maximum inspiratory pressure (MIP) with a pressure measurer (Elka PM-15, Laboliser, S.A., Barcelona, Spain), from residual volume and total lung capacity. Unit of measure, centimeter of water (cmH2O).

Expiratory muscle strength

时间窗: 8 weeks.

It was measured using the maximum expiratory pressure (MEP) with a pressure measurer (Elka PM-15, Laboliser, S.A., Barcelona, Spain), from residual volume and total lung capacity. Unit of measure, centimeter of water (cmH2O).

次要结局

  • Pulmonary volume.(8 weeks.)
  • Pulmonary flow.(8 weeks.)

研究者

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

CARLOS MARTIN SANCHEZ

Principal Investigator

University of Salamanca

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