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临床试验/NCT00629850
NCT00629850终止不适用

Concurrent Respiratory Resistance Training and Changes in Respiratory Muscle Strength and Sleep Quality in Persons With Spinal Cord Injury

Texas State University, San Marcos2 个研究点 分布在 1 个国家目标入组 1 人开始时间: 2008年2月最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
终止
入组人数
1
试验地点
2
主要终点
Change in Negative Inspiratory Force Using a Pressure Manometer

研究概览

简要总结

The purpose of this study is to determine if the use of a respiratory resistance trainer will increase respiratory muscle strength, improve sleep quality and improve quality of life in individuals with spinal cord injury.

Hypothesis: Use of the respiratory resistance trainer will improve respiratory muscle strength, improve sleep quality, and improve quality of life among individuals with spinal cord injury.

详细描述

Individuals with spinal cord injury experience varying degrees of reduced muscle function. Those individuals with high level spinal cord injury, cervical region, may experience reduced diaphragm function. This reduction in function may affect daytime activities as well as sleep quality. Sleep quality in people with spinal cord injury is considered to be worse than sleep quality in the general population. The use of respiratory resistance training devices has been shown to increase muscle strength in people with spinal cord injury. There have been not studies to document potential improvements in sleep quality among individuals with spinal cord injury following respiratory resistance training.

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 (Investigator)

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

  • tetraplegia
  • quadriplegia

排除标准

  • 未提供

研究组 & 干预措施

Powerlung Performer

Experimental

The arm will receive the lung trainer device to use for 10 weeks

干预措施: Powerlung Performer (Device)

Control

No Intervention

Control. This arm will not receive any device

结局指标

主要结局

Change in Negative Inspiratory Force Using a Pressure Manometer

时间窗: 10 weeks

Number of Participants With Improvement in Sleep Quality.

时间窗: 10 weeks

Improvement in sleep quality as defined by: less fragmented sleep, lower apnea hypopnea index (AHI), respiratory disturbance index (RDI) after device use.

Change in Maximum Voluntary Ventilation Using Pulmonary Function Device

时间窗: 10 weeks

Pulmonary function device measures flow rate in liters per minute over a period of at least 12 seconds.

次要结局

未报告次要终点

研究者

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

Chris Russian

Principal Investigator

Texas State University, San Marcos

研究点 (2)

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