Spinal Cord Injury
Conditions
Keywords
spinal cord injury, respiratory muscle training, sleep quality
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.
Interventions
DEVICEPowerlung Performer
Inspiratory/Expiratory muscle trainer
Sponsors
Texas State University, San Marcos
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* tetraplegia * quadriplegia
Exclusion criteria
* NA
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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 | — |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Powerlung Trainer Device The device was used twice a day. Each use consisted of two sets of 10 breaths for each set. | 1 |
| Control This arm of the study will not receive the device. | 0 |
| Total | 1 |
Baseline characteristics
| Characteristic | Powerlung Trainer Device | Control | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 1 Participants | 0 Participants | 1 Participants |
| Region of Enrollment United States | 1 participants | — | 1 participants |
| Sex: Female, Male Female | 0 Participants | 0 Participants | 0 Participants |
| Sex: Female, Male Male | 1 Participants | 0 Participants | 1 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 1 | 0 / 0 |
| serious Total, serious adverse events | 0 / 1 | 0 / 0 |
Outcome results
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.
Time frame: 10 weeks
Population: there was only one participant completing this study. No analyses performed.
Primary
Change in Negative Inspiratory Force Using a Pressure Manometer
Time frame: 10 weeks
Population: there was only one participant completing this study. No analyses performed.
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.
Time frame: 10 weeks
Population: There was only one participant completing the study. No analyses performed.