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| ID | Type | Description | Link |
|---|---|---|---|
| IRB# 2008-29541 | Other Identifier | Texas State University IRB |
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unable to recruit participants.
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Powerlung Performer | Experimental | The arm will receive the lung trainer device to use for 10 weeks |
|
| Control | No Intervention | Control. This arm will not receive any device |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Powerlung Performer | Device | Inspiratory/Expiratory muscle trainer |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Lisa Lloyd, Ph.D. | Texas State University, San Marcos | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Texas State University-San Marcos | San Marcos | Texas | 78666 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | Powerlung Trainer Device | The device was used twice a day. Each use consisted of two sets of 10 breaths for each set. |
| FG001 | Control | This arm of the study will not receive the device. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
This was a single subject case study. No control subjects.
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| ID | Title | Description |
|---|---|---|
| BG000 | Powerlung Trainer Device | The device was used twice a day. Each use consisted of two sets of 10 breaths for each set. |
| BG001 | Control | This arm of the study will not receive the device. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | There was only one participant completing the study. No analyses performed. | Posted | 10 weeks |
|
8 weeks of data collection
Other adverse events.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Powerlung Trainer Device | The device was used twice a day. Each use consisted of two sets of 10 breaths for each set. |
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Unable to recruit subjects for the study
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Chris Russian, Associate Professor | Texas State Respiratory Care Department | 512-245-3794 | cr23@txstate.edu |
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| ID | Term |
|---|---|
| D013119 | Spinal Cord Injuries |
| D007319 | Sleep Initiation and Maintenance Disorders |
| ID | Term |
|---|---|
| D013118 | Spinal Cord Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D020196 | Trauma, Nervous System |
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| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
|
| Units | Counts |
|---|---|
| Participants |
|
| Primary | 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. | there was only one participant completing this study. No analyses performed. | Posted | 10 weeks |
|
|
| Primary | Change in Negative Inspiratory Force Using a Pressure Manometer | there was only one participant completing this study. No analyses performed. | Posted | 10 weeks |
|
|
| 0 |
| 1 |
| 0 |
| 1 |
| EG001 | Control | This arm of the study will not receive the device. | 0 | 0 | 0 | 0 |
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| D014947 | Wounds and Injuries |
| D020919 | Sleep Disorders, Intrinsic |
| D020920 | Dyssomnias |
| D012893 | Sleep Wake Disorders |
| D001523 | Mental Disorders |