Respiratory Resistance Training on Sleep Quality in Persons With Spinal Cord Injury - Full Text View

Sponsored by:	Texas State University, San Marcos
Information provided by:	Texas State University, San Marcos
ClinicalTrials.gov Identifier:	NCT00629850

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
Spinal Cord Injury	Device: Powerlung Performer

MedlinePlus related topics: Spinal Cord Injuries

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Single Blind (Investigator), Parallel Assignment
Official Title:	Concurrent Respiratory Resistance Training and Changes in Respiratory Muscle Strength and Sleep Quality in Persons With Spinal Cord Injury

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

Primary Outcome Measures:

overnight sleep assessment [ Time Frame: 10 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

pulmonary function tests [ Time Frame: 10 weeks ] [ Designated as safety issue: No ]

Estimated Enrollment:	20
Study Start Date:	February 2008
Estimated Study Completion Date:	February 2009
Estimated Primary Completion Date:	April 2008 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
A: Experimental The arm will receive the device	Device: Powerlung Performer Inspiratory/Expiratory muscle trainer
B: No Intervention Control

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

Contacts

Contact: Chris Russian, M.Ed.	512-245-3794	cr23@txstate.edu
Contact: Lyn Litchke, Ph.D.	512-245-2951	ll24@txstate.edu

Locations

United States, Texas
Texas State University-San Marcos	Recruiting
San Marcos, Texas, United States, 78666
Principal Investigator: Chris Russian, M.Ed.

Sponsors and Collaborators

Texas State University, San Marcos

Investigators

Study Chair:

Lisa Lloyd, Ph.D.

Texas State University, San Marcos

More Information

Responsible Party:	Texas State University-San Marcos ( Chris Russian )
Study ID Numbers:	TexasState 2008-29541, IRB# 2008-29541
Study First Received:	February 25, 2008
Last Updated:	February 25, 2008
ClinicalTrials.gov Identifier:	NCT00629850
Health Authority:	United States: Institutional Review Board

Keywords provided by Texas State University, San Marcos:

spinal cord injury
respiratory muscle training
sleep quality

Study placed in the following topic categories:

Spinal Cord Injuries
Spinal Cord Diseases
Wounds and Injuries

Disorders of Environmental Origin
Central Nervous System Diseases
Trauma, Nervous System

Additional relevant MeSH terms:

Nervous System Diseases

ClinicalTrials.gov processed this record on January 16, 2009