Respiratory Resistance Training on Sleep Quality in Persons With Spinal Cord Injury
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.
|Study Design:||Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single Blind (Investigator)
Primary Purpose: Treatment
|Official Title:||Concurrent Respiratory Resistance Training and Changes in Respiratory Muscle Strength and Sleep Quality in Persons With Spinal Cord Injury|
- Number of Participants With Improvement in Sleep Quality. [ Time Frame: 10 weeks ] [ Designated as safety issue: No ]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 [ Time Frame: 10 weeks ] [ Designated as safety issue: No ]pulmonary function device measures flow rate in liters per minute
- Change in Negative Inspiratory Force Using a Pressure Manometer [ Time Frame: 10 weeks ] [ Designated as safety issue: No ]
|Study Start Date:||February 2008|
|Study Completion Date:||September 2009|
|Primary Completion Date:||September 2009 (Final data collection date for primary outcome measure)|
Experimental: Powerlung Performer
The arm will receive the lung trainer device to use for 10 weeks
Device: Powerlung Performer
Inspiratory/Expiratory muscle trainer
Other Name: Respiratory resistance trainer
No Intervention: Control
Control. This arm will not receive any device
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00629850
|United States, Texas|
|Texas State University-San Marcos|
|San Marcos, Texas, United States, 78666|
|Study Chair:||Lisa Lloyd, Ph.D.||Texas State University, San Marcos|