Spinal Cord InjuryNCT00629850
Respiratory Resistance Training on Sleep Quality in Persons With Spinal Cord Injury
A study testing Powerlung Performer in people with Spinal Cord Injury, run by Texas State University, San Marcos at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Spinal Cord Injury
- What is being tested?
- Powerlung Performer
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1 participants
- Where
- 1 siteUnited States
- Study dates
- Feb 2008to Sep 2009
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- tetraplegia
- quadriplegia
Who cannot join
- NA
Trial locations and contacts
1 site in 1 country.
United States1 site
Texas State University-San Marcos
San Marcos, Texas, 78666
About this study
Official title: 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.
Read the 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.
- Conditions
- Spinal Cord Injury
- Being tested
- Powerlung Performer
- Keywords
- spinal cord injury, respiratory muscle training, sleep quality
- Medical subject headings
- Spinal Cord Injuries, Sleep Initiation and Maintenance Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Powerlung PerformerDevice
Also called Respiratory resistance trainer
Inspiratory/Expiratory muscle trainer
| Study group | Role | What they receive |
|---|---|---|
| Powerlung Performer | Experimental | The arm will receive the lung trainer device to use for 10 weeks Receives: Device: Powerlung Performer |
| Control | No intervention | Control. This arm will not receive any device |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 10 weeks
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.
Measured: 10 weeks
Change in Negative Inspiratory Force Using a Pressure Manometer
Measured: 10 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Mar 2008 (estimated)
- Study startFeb 2008
- Primary completionSep 2009
- Study completionSep 2009
Why it stopped: unable to recruit participants.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Spinal Cord InjuryStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 1 participants (actual)
Sponsor and investigators
- Lead sponsor
- Texas State University, San Marcos
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Chris Russian, Texas State University, San Marcos
- Investigators
- Lisa Lloyd, Ph.D., Study chair, Texas State University, San Marcos
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00629850
- Sponsor's protocol ID
- TexasState 2008-29541
- Other IDs
- IRB# 2008-29541
- Status last verified
- Apr 2019
- First submitted
- 25 Feb 2008
- Last updated
- 8 May 2019
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 May 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Concurrent Respiratory Resistance Training and Changes in Respiratory Muscle Strength and Sleep Quality in Persons With Spinal Cord Injury
- ClinicalTrials.gov ID
- NCT00629850
- Acronym / sponsor ID
- TexasState 2008-29541
- Conditions
- Spinal Cord Injury
- Keywords
- spinal cord injury, respiratory muscle training, sleep quality
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: unable to recruit participants.
- Enrolment
- 1 participants (actual)
- Lead sponsor
- Texas State University, San MarcosUniversity, hospital or other
- Study start
- Feb 2008
- Primary completion
- Sep 2009 (actual)
- Study completion
- Sep 2009 (actual)
- First posted
- 6 Mar 2008 (estimated)
- Results
- Posted 18 Aug 2011
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Powerlung Performer | Experimental | Device: Powerlung PerformerThe arm will receive the lung trainer device to use for 10 weeks |
| Control | No intervention | –Control. This arm will not receive any device |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- tetraplegia
- quadriplegia
Key exclusion criteria (1 listed)
- NA
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Powerlung PerformerAlso: Respiratory resistance trainerInspiratory/Expiratory muscle trainer | Device | Powerlung Performer |
Primary outcome
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.
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.
Change in Negative Inspiratory Force Using a Pressure Manometer
Time frame: 10 weeks
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 May 2019.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Lisa Lloyd, Ph.D. study chair
Texas State University, San Marcos
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Powerlung Performer in people with Spinal Cord Injury, run by Texas State University, San Marcos at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 8 May 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 18 Aug 2011). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Participants With Improvement in Sleep Quality. (time frame: 10 weeks). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 May 2019.