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

NCT ID: NCT00629850

Last Updated: 2019-05-08

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

NA

Total Enrollment

1 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-02-29

Study Completion Date

2009-09-30

Brief Summary

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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

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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.

Conditions

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Spinal Cord Injury

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Investigators

Study Groups

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Powerlung Performer

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

Group Type EXPERIMENTAL

Powerlung Performer

Intervention Type DEVICE

Inspiratory/Expiratory muscle trainer

Control

Control. This arm will not receive any device

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Powerlung Performer

Inspiratory/Expiratory muscle trainer

Intervention Type DEVICE

Other Intervention Names

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Respiratory resistance trainer

Eligibility Criteria

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Inclusion Criteria

* tetraplegia
* quadriplegia

Exclusion Criteria

* NA
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Texas State University, San Marcos

OTHER

Sponsor Role lead

Responsible Party

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Chris Russian

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Lisa Lloyd, Ph.D.

Role: STUDY_CHAIR

Texas State University, San Marcos

Locations

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Texas State University-San Marcos

San Marcos, Texas, United States

Site Status

Countries

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United States

Other Identifiers

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IRB# 2008-29541

Identifier Type: OTHER

Identifier Source: secondary_id

TexasState 2008-29541

Identifier Type: -

Identifier Source: org_study_id

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