An interventional study of Powerlung Performer in Spinal Cord Injury, sponsored by Texas State University, San Marcos. Terminated at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2019-05-08.
Sponsored by Texas State University, San Marcos · Not applicable, Interventional, and Treatment
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.
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.
1,948 studies on the registry are indexed under Spinal Cord Injuries; 505 are open to participants now.
This study's enrollment of 1 is below the median of 24 across 1,566 interventional studies indexed under Spinal Cord Injuries.
Browse Spinal Cord Injuries studies →Texas State University, San Marcos is the lead sponsor of 3 studies on the registry; none are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
The arm will receive the lung trainer device to use for 10 weeks
Device: Powerlung Performer
Control. This arm will not receive any device
Inspiratory/Expiratory muscle trainer
Also known as: Respiratory resistance trainer
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.
Time frame: 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.
Time frame: 10 weeks
Change in Negative Inspiratory Force Using a Pressure Manometer
Time frame: 10 weeks
| Milestone | Powerlung Trainer Device | Control |
|---|---|---|
| Started | 1 | 0 |
| Completed | 1 | 0 |
| Not completed | 0 | 0 |
Improvement in sleep quality as defined by: less fragmented sleep, lower apnea hypopnea index (AHI), respiratory disturbance index (RDI) after device use.
No measurements were reported for this outcome.
Pulmonary function device measures flow rate in liters per minute over a period of at least 12 seconds.
No measurements were reported for this outcome.
No measurements were reported for this outcome.
Collected over 8 weeks of data collection. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Powerlung Trainer Device | — | 0/1 (0%) | 0/1 (0%) |
| Control | — | — | — |
This was a single subject case study. No control subjects.
| Age, Categorical(Participants) | Powerlung Trainer Device | Control | Total |
|---|---|---|---|
| <=18 years | 0 | 0 | 0 |
| Between 18 and 65 years | 1 | 0 | 1 |
| >=65 years | 0 | 0 | 0 |
| Sex: Female, Male(Participants) | Powerlung Trainer Device | Control | Total |
|---|---|---|---|
| Female | 0 | 0 | 0 |
| Male | 1 | 0 | 1 |
| Region of Enrollment(participants) | Powerlung Trainer Device | Control | Total |
|---|---|---|---|
| United States | 1 | — | 1 |
This study is terminated, as verified in Apr 2019. You cannot join it, but the record below documents what was studied.
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Texas State University, San Marcos