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

April 27, 2019 updated by: Chris Russian, Texas State University, San Marcos

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

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.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

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

Enrollment (Actual)

1

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Texas
      • San Marcos, Texas, United States, 78666
        • Texas State University-San Marcos

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • tetraplegia
  • quadriplegia

Exclusion Criteria:

  • NA

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / 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 Names:
  • Respiratory resistance trainer
No Intervention: Control
Control. This arm will not receive any device

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
10 weeks
Change in Maximum Voluntary Ventilation Using Pulmonary Function Device
Time Frame: 10 weeks
Pulmonary function device measures flow rate in liters per minute over a period of at least 12 seconds.
10 weeks
Change in Negative Inspiratory Force Using a Pressure Manometer
Time Frame: 10 weeks
10 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Texas State University, San Marcos

Investigators

  • Study Chair: Lisa Lloyd, Ph.D., Texas State University, San Marcos

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 2008

Primary Completion (Actual)

September 1, 2009

Study Completion (Actual)

September 1, 2009

Study Registration Dates

First Submitted

February 25, 2008

First Submitted That Met QC Criteria

February 25, 2008

First Posted (Estimate)

March 6, 2008

Study Record Updates

Last Update Posted (Actual)

May 8, 2019

Last Update Submitted That Met QC Criteria

April 27, 2019

Last Verified

April 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • TexasState 2008-29541
  • IRB# 2008-29541 (Other Identifier: Texas State University IRB)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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