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

Primary Purpose

Spinal Cord Injury

Status
Terminated
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Powerlung Performer
Sponsored by
Texas State University, San Marcos
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Spinal Cord Injury focused on measuring spinal cord injury, respiratory muscle training, sleep quality

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • tetraplegia
  • quadriplegia

Exclusion Criteria:

  • NA

Sites / Locations

  • Texas State University-San Marcos

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Powerlung Performer

Control

Arm Description

The arm will receive the lung trainer device to use for 10 weeks

Control. This arm will not receive any device

Outcomes

Primary Outcome Measures

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.
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.
Change in Negative Inspiratory Force Using a Pressure Manometer

Secondary Outcome Measures

Full Information

First Posted
February 25, 2008
Last Updated
April 27, 2019
Sponsor
Texas State University, San Marcos
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1. Study Identification

Unique Protocol Identification Number
NCT00629850
Brief Title
Respiratory Resistance Training on Sleep Quality in Persons With Spinal Cord Injury
Official Title
Concurrent Respiratory Resistance Training and Changes in Respiratory Muscle Strength and Sleep Quality in Persons With Spinal Cord Injury
Study Type
Interventional

2. Study Status

Record Verification Date
April 2019
Overall Recruitment Status
Terminated
Why Stopped
unable to recruit participants.
Study Start Date
February 2008 (undefined)
Primary Completion Date
September 2009 (Actual)
Study Completion Date
September 2009 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Texas State University, San Marcos

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Spinal Cord Injury
Keywords
spinal cord injury, respiratory muscle training, sleep quality

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Investigator
Allocation
Randomized
Enrollment
1 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Powerlung Performer
Arm Type
Experimental
Arm Description
The arm will receive the lung trainer device to use for 10 weeks
Arm Title
Control
Arm Type
No Intervention
Arm Description
Control. This arm will not receive any device
Intervention Type
Device
Intervention Name(s)
Powerlung Performer
Other Intervention Name(s)
Respiratory resistance trainer
Intervention Description
Inspiratory/Expiratory muscle trainer
Primary Outcome Measure Information:
Title
Number of Participants With Improvement in Sleep Quality.
Description
Improvement in sleep quality as defined by: less fragmented sleep, lower apnea hypopnea index (AHI), respiratory disturbance index (RDI) after device use.
Time Frame
10 weeks
Title
Change in Maximum Voluntary Ventilation Using Pulmonary Function Device
Description
Pulmonary function device measures flow rate in liters per minute over a period of at least 12 seconds.
Time Frame
10 weeks
Title
Change in Negative Inspiratory Force Using a Pressure Manometer
Time Frame
10 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: tetraplegia quadriplegia Exclusion Criteria: NA
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Lisa Lloyd, Ph.D.
Organizational Affiliation
Texas State University, San Marcos
Official's Role
Study Chair
Facility Information:
Facility Name
Texas State University-San Marcos
City
San Marcos
State/Province
Texas
ZIP/Postal Code
78666
Country
United States

12. IPD Sharing Statement

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

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