Study Stopped
unable to recruit participants.
Respiratory Resistance Training on Sleep Quality in Persons With Spinal Cord Injury
Concurrent Respiratory Resistance Training and Changes in Respiratory Muscle Strength and Sleep Quality in Persons With Spinal Cord Injury
2 other identifiers
interventional
1
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Feb 2008
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
February 1, 2008
CompletedFirst Submitted
Initial submission to the registry
February 25, 2008
CompletedFirst Posted
Study publicly available on registry
March 6, 2008
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 1, 2009
CompletedStudy Completion
Last participant's last visit for all outcomes
September 1, 2009
CompletedResults Posted
Study results publicly available
August 18, 2011
CompletedMay 8, 2019
April 1, 2019
1.6 years
February 25, 2008
July 19, 2011
April 27, 2019
Conditions
Keywords
Outcome Measures
Primary Outcomes (3)
Number of Participants With Improvement in Sleep Quality.
Improvement in sleep quality as defined by: less fragmented sleep, lower apnea hypopnea index (AHI), respiratory disturbance index (RDI) after device use.
10 weeks
Change in Maximum Voluntary Ventilation Using Pulmonary Function Device
Pulmonary function device measures flow rate in liters per minute over a period of at least 12 seconds.
10 weeks
Change in Negative Inspiratory Force Using a Pressure Manometer
10 weeks
Study Arms (2)
Powerlung Performer
EXPERIMENTALThe arm will receive the lung trainer device to use for 10 weeks
Control
NO INTERVENTIONControl. This arm will not receive any device
Interventions
Inspiratory/Expiratory muscle trainer
Eligibility Criteria
You may qualify if:
- tetraplegia
- quadriplegia
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Texas State University-San Marcos
San Marcos, Texas, 78666, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Limitations and Caveats
Unable to recruit subjects for the study
Results Point of Contact
- Title
- Chris Russian, Associate Professor
- Organization
- Texas State Respiratory Care Department
Study Officials
- STUDY CHAIR
Lisa Lloyd, Ph.D.
Texas State University, San Marcos
Publication Agreements
- PI is Sponsor Employee
- Yes
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Principal Investigator
Study Record Dates
First Submitted
February 25, 2008
First Posted
March 6, 2008
Study Start
February 1, 2008
Primary Completion
September 1, 2009
Study Completion
September 1, 2009
Last Updated
May 8, 2019
Results First Posted
August 18, 2011
Record last verified: 2019-04