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临床试验/NCT06230692
NCT06230692招募中不适用

Understanding the Influence of Diaphragm Structure and Function on the Control of Breathing During Exercise in Children

University of Maryland, Baltimore2 个研究点 分布在 1 个国家目标入组 13 人开始时间: 2024年3月16日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
入组人数
13
试验地点
2
主要终点
Percent completion

研究概览

简要总结

The purpose of this research is to study the feasibility of a specific training program for the breathing muscles (inspiratory muscle training) and the effects on how breathing is regulated during exercise in typically developing children.

详细描述

During the first study visit, participants will undergo a series of pulmonary function and muscle performance tests followed by treadmill walking trials at different speeds with concurrent expired gas analysis via a face mask. The participants will then perform a training program for the breathing muscles at home for 6 weeks. The research team will follow up each week via telehealth visits to support training. After the 6-week training program, participants will return in-person for a follow-up visit and will undergo the same series of assessments as the first visit.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Supportive Care
盲法
None

入排标准

年龄范围
6 Years 至 12 Years(Child)
性别
All
接受健康志愿者

入选标准

  • Age range 6-12 years of age

排除标准

  • History of neuromuscular, cardiac, or pulmonary disease
  • Known intellectual or developmental problems that would preclude the ability to assent
  • Ruptured eardrum
  • Recent injury or condition (less than 6 months ago) that precludes strength testing or walking
  • Recent (less than 2 weeks ago) or current respiratory or other type of illness

结局指标

主要结局

Percent completion

时间窗: 6 weeks

Percentage of enrolled participants who complete the 6-week inspiratory muscle training protocol

Adherence to treatment protocol

时间窗: 6 weeks

Number of sets and repetitions of training breaths completed during the 6-week inspiratory muscle training protocol

次要结局

  • Maximal inspiratory pressure (measured in cm H2O)(6 weeks)
  • Diaphragm thickness (measured in mm)(6 weeks)
  • Exercise ventilation(6 weeks)

研究者

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

Simon Ho

Assistant Professor

University of Maryland, Baltimore

研究点 (2)

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