Ignite Creation Date:
2025-12-24 @ 5:10 PM
Ignite Modification Date:
2025-12-29 @ 10:57 AM
Study NCT ID:
NCT00629850
Status:
TERMINATED
Last Update Posted:
2019-05-08
First Post:
2008-02-25
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Respiratory Resistance Training on Sleep Quality in Persons With Spinal Cord Injury
Sponsor:
Texas State University, San Marcos
Organization:
Study Overview
Official Title:
Concurrent Respiratory Resistance Training and Changes in Respiratory Muscle Strength and Sleep Quality in Persons With Spinal Cord Injury
Status:
TERMINATED
Status Verified Date:
2019-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
unable to recruit participants.
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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.
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 Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
Secondary ID Infos
| Secondary ID | Type | Domain | Link | View |
|---|---|---|---|---|
| IRB# 2008-29541 | OTHER | Texas State University IRB | View |