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

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ClinicalTrials.gov Identifier: NCT00629850
Recruitment Status : Terminated (unable to recruit participants.)
First Posted : March 6, 2008
Results First Posted : August 18, 2011
Last Update Posted : August 18, 2011
Sponsor:
Information provided by:
Texas State University, San Marcos

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.


Condition or disease Intervention/treatment Phase
Spinal Cord Injury Device: Powerlung Performer Phase 1

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.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 1 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Investigator)
Primary Purpose: Treatment
Official Title: Concurrent Respiratory Resistance Training and Changes in Respiratory Muscle Strength and Sleep Quality in Persons With Spinal Cord Injury
Study Start Date : February 2008
Actual Primary Completion Date : September 2009
Actual Study Completion Date : September 2009

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
Experimental: Powerlung Performer
The arm will receive the lung trainer device to use for 10 weeks
Device: Powerlung Performer
Inspiratory/Expiratory muscle trainer
Other Name: Respiratory resistance trainer
No Intervention: Control
Control. This arm will not receive any device



Primary Outcome Measures :
  1. Number of Participants With Improvement in Sleep Quality. [ Time Frame: 10 weeks ]
    Improvement in sleep quality as defined by: less fragmented sleep, lower apnea hypopnea index (AHI), respiratory disturbance index (RDI) after device use.

  2. Change in Maximum Voluntary Ventilation Using Pulmonary Function Device [ Time Frame: 10 weeks ]
    pulmonary function device measures flow rate in liters per minute

  3. Change in Negative Inspiratory Force Using a Pressure Manometer [ Time Frame: 10 weeks ]


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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • tetraplegia
  • quadriplegia

Exclusion Criteria:


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00629850


Locations
United States, Texas
Texas State University-San Marcos
San Marcos, Texas, United States, 78666
Sponsors and Collaborators
Texas State University, San Marcos
Investigators
Study Chair: Lisa Lloyd, Ph.D. Texas State University, San Marcos

Responsible Party: Chris Russian, Texas State University-San Marcos
ClinicalTrials.gov Identifier: NCT00629850     History of Changes
Other Study ID Numbers: TexasState 2008-29541
IRB# 2008-29541 ( Other Identifier: Texas State University IRB )
First Posted: March 6, 2008    Key Record Dates
Results First Posted: August 18, 2011
Last Update Posted: August 18, 2011
Last Verified: August 2011

Keywords provided by Texas State University, San Marcos:
spinal cord injury
respiratory muscle training
sleep quality

Additional relevant MeSH terms:
Wounds and Injuries
Spinal Cord Injuries
Spinal Cord Diseases
Central Nervous System Diseases
Nervous System Diseases
Trauma, Nervous System