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

This study has been terminated.
(unable to recruit participants.)
Sponsor:
Information provided by:
Texas State University, San Marcos
ClinicalTrials.gov Identifier:
NCT00629850
First received: February 25, 2008
Last updated: August 17, 2011
Last verified: August 2011
History of Changes
  Purpose

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 Intervention Phase
Spinal Cord Injury
 Device: Powerlung Performer
 Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single Blind (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

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Texas State University, San Marcos:

Primary Outcome Measures:
  • Number of Participants With Improvement in Sleep Quality. [ Time Frame: 10 weeks ] [ Designated as safety issue: No ]
    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 [ Time Frame: 10 weeks ] [ Designated as safety issue: No ]
    pulmonary function device measures flow rate in liters per minute

  • Change in Negative Inspiratory Force Using a Pressure Manometer [ Time Frame: 10 weeks ] [ Designated as safety issue: No ]

Enrollment: 1
Study Start Date: February 2008
Study Completion Date: September 2009
Primary Completion Date: September 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • tetraplegia
  • quadriplegia

Exclusion Criteria:

  • NA
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: 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
  More Information

No publications provided

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
Study First Received: February 25, 2008
Results First Received: July 19, 2011
Last Updated: August 17, 2011
Health Authority: United States: Institutional Review Board

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

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

ClinicalTrials.gov processed this record on June 18, 2013