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临床试验/NCT05603507
NCT05603507已完成不适用

Inspiratory Muscle Training Effects on Pulmonary Function and Quality of Life in Children With Chest Burn

Qassim University1 个研究点 分布在 1 个国家目标入组 40 人开始时间: 2021年9月10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
入组人数
40
试验地点
1
主要终点
Pulmonary function test, FEV1/FVC ratio

研究概览

简要总结

8 weeks of inspiratory muscle training combined with a pulmonary rehabilitation program increases respiratory muscle strength, pulmonary function, functional capacity, and quality of life in chest burned children.

详细描述

The primary purpose of this study is to see how an inspiratory muscle training program along with a pulmonary rehabilitation program improved respiratory muscle strength, respiratory function and quality of life after children with chest burns were discharged from the hospital.

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 (Outcomes Assessor)

入排标准

年龄范围
10 Years 至 18 Years(Child, Adult)
性别
All
接受健康志愿者
否

入选标准

  • •Children aged 10 to
  • •Following hospital discharge.- Total body surface area (TBSA) of 30% to 50%.
  • •Chest burns.
  • •Deep partial to full thickness burns.
  • •Subjects who had a skin graft or who healed completely were also included.

排除标准

  • •- Participants who had a nonhealing or open wound.
  • •Congenital diaphragmatic hernia.
  • •Chest wall deformity.
  • •Cardiac or pulmonary problems.

研究组 & 干预措施

inspiratory muscle training group

Experimental

received both inspiratory muscle training and pulmonary rehabilitation

干预措施: inspiratory muscle training (Other)

inspiratory muscle training group

Experimental

received both inspiratory muscle training and pulmonary rehabilitation

干预措施: pulmonary rehabilitation (Other)

pulmonary rehabilitation group

Sham Comparator

received only pulmonary rehabilitation and sham inspiratory muscle training

干预措施: pulmonary rehabilitation (Other)

结局指标

主要结局

Pulmonary function test, FEV1/FVC ratio

时间窗: 8 weeks

performed using a spirometer, (forced expiratory volume in the first second/ forced vital capacity) FEV1/FVC ratio was recorded.

maximal inspiratory pressure

时间窗: 8 weeks

performed using an electronic respiratory pressure meter

maximal expiratory pressure

时间窗: 8 weeks

performed using an electronic respiratory pressure meter

Pulmonary function test, forced expiratory volume in the first second

时间窗: 8 weeks

performed using a spirometer, the FEV1 (forced expiratory volume in the first second) was recorded.

Pulmonary function test, forced vital capacity

时间窗: 8 weeks

performed using a spirometer, the FVC (forced vital capacity) was recorded.

maximal inspiratory pressure

时间窗: 1 week after hospital discharge

performed using an electronic respiratory pressure meter

maximal expiratory pressure

时间窗: 1 week after hospital discharge

performed using an electronic respiratory pressure meter

Pulmonary function test, forced expiratory volume in the first second

时间窗: 1 week after hospital discharge

performed using a spirometer, the FEV1 (forced expiratory volume in the first second) was recorded.

Pulmonary function test, forced vital capacity

时间窗: 1 week after hospital discharge

performed using a spirometer, the FVC (forced vital capacity) was recorded.

Pulmonary function test, FEV1/FVC ratio

时间窗: 1 week after hospital discharge

performed using a spirometer, (forced expiratory volume in the first second/ forced vital capacity) FEV1/FVC ratio was recorded.

次要结局

  • Functional exercise capacity(8 weeks)
  • Health related Quality of Life(8 weeks)
  • Functional exercise capacity(1 week after hospital discharge)
  • Health related Quality of Life(1 week after hospital discharge)

研究者

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

Maged Basha

Assistant Professor, College of Medical Rehabilitation, Qassim University

Qassim University

研究点 (1)

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