Concurrent Respiratory Resistance Training and Changes in Respiratory Muscle Strength and Sleep Quality in Persons With Spinal Cord Injury
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
- 否
入选标准
- •tetraplegia
- •quadriplegia
排除标准
- 未提供
研究组 & 干预措施
Powerlung Performer
The arm will receive the lung trainer device to use for 10 weeks
干预措施: Powerlung Performer (Device)
Control
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
Chris Russian
Principal Investigator
Texas State University, San Marcos
