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临床试验/NCT04900649
NCT04900649已完成不适用

Effect of Chest Resistance Exercise Combined With Chest Expansion Exercises on Respiratory Muscle Strength, Lung Function, and Thoracic Excursion in Children With Post-operative Congenital Diaphragmatic Hernia

Qassim University1 个研究点 分布在 1 个国家目标入组 32 人开始时间: 2020年5月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
32
试验地点
1
主要终点
Respiratory muscle Strength

研究概览

简要总结

Congenital diaphragmatic hernia (CDH) is a life-threatening condition with long-term complications including respiratory tract infections, respiratory muscle weakness, and abnormal lung functions. This study, therefore, has been designed to ascertain the effect of chest resistance exercise and chest expansion exercise on respiratory muscle strength, lung function, and chest mobility in children with post-operative CDH.

详细描述

With the advances in surgical and neonatal treatment, the survival rates in children with CDH have been improved in the last decades. The surviving children may suffer from long-term complications such as impairments in lung growth (lung hypoplasia), cardiovascular disorders, pulmonary hypertension, gastrointestinal problems, and recurrent occurrence of lower respiratory tract infection. One of the physical therapy techniques used to treat chest disorders via encouraging the normal alignment of respiratory muscles with respiratory rhythm is chest resistance exercise through applying resistance to the sternal and coastal areas .

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 14 Years(Child)
性别
All
接受健康志愿者

入选标准

  • ages between 10 and 14 years.
  • the BMI between 20 and 25 Kg/m
  • the children were considered as high risky CDH as they developed respiratory distress in the first days of their life.
  • CDH was corrected surgically immediately after birth.
  • children are still in following upstate in pediatric and physical therapy departments.

排除标准

  • physical disability.
  • diaphragmatic eventration.
  • unable to perform all tests or procedures.
  • children with cardiac anomalies

结局指标

主要结局

Respiratory muscle Strength

时间窗: after 12 weeks

evaluated by using POWER breathe KH2 equipment.

Lung functions

时间窗: after 12 weeks

assessed by the Minispir® Light spirometer with Winspiro® Light software. The child was seated with knees flexed 90° and was asked to hold three deep breaths, take deep inspiration to total lung capacity (TLC), then expire all the air inside the lungs to their residual volume (RV) to obtain the variables FEV1 (forced expiratory volume in 1 s) and FVC (forced vital capacity).

次要结局

  • Thoracic excursion(after 12 weeks)

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, Saudi Arabia, Qassim, Buraidah. Consultant Physical Therapist, El-Sahel Teaching Hospital, General Organization for Teaching Hospitals and Institutes, Cairo, Egypt.

Qassim University

研究点 (1)

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