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

Spinal Cord Injury Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00629850
• Other study ID #: TexasState 2008-29541
• Secondary ID: IRB# 2008-29541
• Status: Terminated
• Phase: N/A
• Start date: February 2008
• Est. completion date: September 2009

Study information

• Verified date: April 2019
• Source: Texas State University, San Marcos
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 1
• Est. completion date: September 2009
• Est. primary completion date: September 2009
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• tetraplegia

• quadriplegia

Exclusion Criteria:

• NA

Related Conditions & MeSH terms

• Spinal Cord Injuries
• Spinal Cord Injury
• Wounds and Injuries

Intervention

Device:
• Powerlung Performer
Inspiratory/Expiratory muscle trainer

Locations

Country	Name	City	State
United States	Texas State University-San Marcos	San Marcos	Texas

Sponsors (1)

Lead Sponsor	Collaborator
Texas State University, San Marcos

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
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.	10 weeks
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.	10 weeks
Primary	Change in Negative Inspiratory Force Using a Pressure Manometer		10 weeks