Respiratory Resistance Training on Sleep Quality in Persons With Spinal Cord Injury

Not Applicable

Terminated

• Conditions: Spinal Cord Injury
• Interventions: Device: Powerlung Performer

• Registration Number: NCT00629850
• Lead Sponsor: Texas State University, San Marcos

Brief Summary

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.

Detailed Description

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.

Study Timeline

• Study Start: 2008-02
• Study First Submitted: 2008-02-25
• Study First Submitted QC: 2008-02-25
• Study First Posted: 2008-03-06
• Primary Completion: 2009-09
• Study Completion: 2009-09
• Results First Submitted: 2011-07-19
• Results First Submitted QC: 2011-08-17
• Results First Posted: 2011-08-18
• Status Verified: 2019-04
• Last Update Submitted: 2019-04-27
• Last Update Posted: 2019-05-08

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 1

Inclusion Criteria

• tetraplegia
• quadriplegia

Exclusion Criteria

• NA

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Powerlung Performer	Powerlung Performer	The arm will receive the lung trainer device to use for 10 weeks

Primary Outcome Measures

Name	Time	Method
Number of Participants With Improvement in Sleep Quality.	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	10 weeks	Pulmonary function device measures flow rate in liters per minute over a period of at least 12 seconds.
Change in Negative Inspiratory Force Using a Pressure Manometer	10 weeks

Trial Locations

Locations (1)

Texas State University-San Marcos; 🇺🇸 San Marcos, Texas, United States