Respiratory Resistance Training on Sleep Quality in Persons With Spinal Cord Injury

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Concurrent Respiratory Resistance Training and Changes in Respiratory Muscle Strength and Sleep Quality in Persons With Spinal Cord Injury

Conditions
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Spinal Cord Injury

Intervention / Treatment
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* Device: Powerlung Performer


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: tetraplegia quadriplegia Exclusion Criteria: NA

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Powerlung Performer<br>The arm will receive the lung trainer device to use for 10 weeks | Device: Powerlung Performer<br>* Inspiratory/Expiratory muscle trainer<br>* Other names: Respiratory resistance trainer;|
| No Intervention: Control<br>Control. This arm will not receive any device | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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spinal cord injury, respiratory muscle training, sleep quality