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Intermittent Hypoxia to Enhance Motor Function After Spinal Cord Injury

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03071393
Recruitment Status : Recruiting
First Posted : March 6, 2017
Last Update Posted : March 10, 2020
Sponsor:
Information provided by (Responsible Party):
University of Florida

Tracking Information
First Submitted Date  ICMJE February 20, 2017
First Posted Date  ICMJE March 6, 2017
Last Update Posted Date March 10, 2020
Actual Study Start Date  ICMJE July 10, 2017
Estimated Primary Completion Date March 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: June 22, 2018)
  • Change in Neuromuscular Recovery Scale seated component scores [ Time Frame: Change between baseline- and 30 minutes post-intermittent hypoxia or sham. ]
    The degree to which subjects can independently perform certain tasks that require trunk muscles will be assessed with the Neuromuscular Recovery Scale. Four components of this standard, reliable and responsive clinical test of functional ability for people with SCI will be used. Standardized instructions will be provided to the subjects for each component. These components include:
    1. Sit - testing the subject's ability to sit tall with proper posture when the feet are flat on the floor.
    2. Reverse Sit-up - subjects will be asked to lower themselves from sitting up to lying supine on a mat as slowly and controlled as possible.
    3. Sit-up - the subject's ability to sit up from lying supine on a table while the feet are on the ground will be assessed.
    4. Trunk extension in sitting - while seated on a table with feet on the floor, subjects will be asked to lean forward with their arms hanging down, and then return to a seated position without using their hands.
  • Change in Maximal Inspiratory Pressure [ Time Frame: Change between baseline- and 30 minutes post-intermittent hypoxia or sham. ]
    An assessment of inspiration strength, assessed using a digital respiratory pressure meter.
  • Change in Maximal Expiratory Pressure [ Time Frame: Change between baseline- and 30 minutes post-intermittent hypoxia or sham. ]
    An assessment of expiration strength, assessed using a digital respiratory pressure meter.
  • Change in Forced Vital Capacity [ Time Frame: Change between baseline- and 30 minutes post-intermittent hypoxia or sham. ]
    An assessment of how much air a person can forcefully exhale after a maximal inspiratory effort. Tests are conducted using a digital spirometer or respiratory monitor.
  • Change in Mouth Occlusion Pressure (P0.1) [ Time Frame: Change between baseline- and 30 minutes post-intermittent hypoxia or sham. ]
    An assessment of the pressure generated in the first 0.1 seconds of the participant's initiation of inhalation.Up to 10 trials of mouth occlusion pressure (P0.1) will be measured to ensure a valid measurement.
  • Change in postural strength in sitting [ Time Frame: Change between baseline- and 30 minutes post-intermittent hypoxia or sham. ]
    Assessed by asking subjects to remain sitting upright while a study staff member applies force to the participant's upper chest, shoulders, or back using a hand-held force meter to record the amount of resistance provided by the participant. Participants will be spotted as necessary by study staff in case the participant is unable to balance themselves during the test.
Original Primary Outcome Measures  ICMJE
 (submitted: March 3, 2017)
  • Change in Neuromuscular Recovery Scale seated component scores [ Time Frame: Change between baseline- and 30 minutes post-intermittent hypoxia or sham. ]
    The degree to which subjects can independently perform certain tasks that require trunk muscles will be assessed with the Neuromuscular Recovery Scale. Four components of this standard, reliable and responsive clinical test of functional ability for people with SCI will be used. Standardized instructions will be provided to the subjects for each component. These components include:
    1. Sit - testing the subject's ability to sit tall with proper posture when the feet are flat on the floor.
    2. Reverse Sit-up - subjects will be asked to lower themselves from sitting up to lying supine on a mat as slowly and controlled as possible.
    3. Sit-up - the subject's ability to sit up from lying supine on a table while the feet are on the ground will be assessed.
    4. Trunk extension in sitting - while seated on a table with feet on the floor, subjects will be asked to lean forward with their arms hanging down, and then return to a seated position without using their hands.
  • Change in Maximal Inspiratory Pressure [ Time Frame: Change between baseline- and 30 minutes post-intermittent hypoxia or sham. ]
    An assessment of inspiration strength, assessed using a digital respiratory pressure meter.
  • Change in Maximal Expiratory Pressure [ Time Frame: Change between baseline- and 30 minutes post-intermittent hypoxia or sham. ]
    An assessment of expiration strength, assessed using a digital respiratory pressure meter.
  • Change in Forced Vital Capacity [ Time Frame: Change between baseline- and 30 minutes post-intermittent hypoxia or sham. ]
    An assessment of how much air a person can forcefully exhale after a maximal inspiratory effort. Tests are conducted using a digital spirometer or respiratory monitor.
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: June 22, 2018)
  • Electromyography (EMG) of trunk and accessory respiratory muscles. [ Time Frame: Change between baseline- and 30 minutes post-intermittent hypoxia or sham. ]
    Activation and timing of activation of trunk and other accessory respiratory muscles will be measured using EMG, which are small sensors that attach to the skin.
  • Trunk and hip angles and position during assessments [ Time Frame: Change between baseline- and 30 minutes post-intermittent hypoxia or sham. ]
    Electrogoniometers, sensors used to calculate joint angles, may be placed on the hips or the trunk to allow for measurement of the angle of those segments during each assessment task.
  • Timed Up and Go test [ Time Frame: Change between baseline- and 30 minutes post-intermittent hypoxia or sham. ]
    An assessment of walking balance and fall risk based on the participant's ability to stand up from a seated position, walk 10 meters, turn around, return to their chair and sit down. This test will only be performed by subjects who can safely attempt it.
  • 10 Meter Walk test [ Time Frame: Change between baseline- and 30 minutes post-intermittent hypoxia or sham. ]
    An assessment of walking speed over a distance of 10 meters. This test will only be performed by subjects who can safely attempt it.
  • 30 Second Chair Stand test [ Time Frame: Change between baseline- and 30 minutes post-intermittent hypoxia or sham. ]
    An assessment of lower body strength and power which evaluates the maximum amount of times that a participant can safely stand up from a seated position and sit back down. This test will only be performed by subjects who can safely attempt it.
Original Secondary Outcome Measures  ICMJE
 (submitted: March 3, 2017)
  • Electromyography (EMG) of trunk and accessory respiratory muscles. [ Time Frame: Change between baseline- and 30 minutes post-intermittent hypoxia or sham. ]
    Activation and timing of activation of trunk and other accessory respiratory muscles will be measured using EMG, which are small sensors that attach to the skin.
  • Trunk and hip angles and position during assessments [ Time Frame: Change between baseline- and 30 minutes post-intermittent hypoxia or sham. ]
    Electrogoniometers, sensors used to calculate joint angles, may be placed on the hips or the trunk to allow for measurement of the angle of those segments during each assessment task.
  • Timed Up and Go test [ Time Frame: Change between baseline- and 30 minutes post-intermittent hypoxia or sham. ]
    An assessment of walking balance and fall risk based on the participant's ability to stand up from a seated position, walk 10 meters, turn around, return to their chair and sit down. This test will only be performed by subjects who can safely attempt it.
  • 10 Meter Walk test [ Time Frame: Change between baseline- and 30 minutes post-intermittent hypoxia or sham. ]
    An assessment of walking speed over a distance of 10 meters. This test will only be performed by subjects who can safely attempt it.
  • 5 Times Sit-to-Stand test [ Time Frame: Change between baseline- and 30 minutes post-intermittent hypoxia or sham. ]
    An assessment of lower body strength and power which evaluates the shortest time that a participant can safely stand up from a seated position and sit back down 5 times in a row. This test will only be performed by subjects who can safely attempt it.
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Intermittent Hypoxia to Enhance Motor Function After Spinal Cord Injury
Official Title  ICMJE Acute Intermittent Hypoxia to Enhance Motor Function After Spinal Cord Injury
Brief Summary This study will examine if acute intermittent hypoxia (brief episodes of breathing lower oxygen), which has been shown to enhance plasticity and motor output, can enhance functional outcomes and muscle activation in individuals with spinal cord injury. Our aim is to assess breathing, sitting, standing and walking functional ability before and after acute intermittent hypoxia, compared to a sham treatment. This information may be useful in advancing rehabilitation for people with spinal cord injuries.
Detailed Description

Recent evidence has shown that acute intermittent hypoxia can strengthen motor pathways after spinal cord injury, and enhance walking outcomes after walking rehabilitation compared to walking rehabilitation alone. A single session of acute intermittent hypoxia has also been shown to temporarily enhance breathing and limb strength in people with spinal cord injury. Further evidence supports the hypothesis that acute intermittent hypoxia acts on all motor pathways, and thus can enhance the strength of most muscles in the body.

Spinal cord injury affects the trunk muscles that control respiration and posture. Decreased respiratory muscle function can lead to diseases of the respiratory system, which are the primary cause of death and significant cause of re-hospitalization after spinal cord injury. Deficits in postural muscle function affect one's ability to balance, safely maintain a seated position, or ambulate after spinal cord injury, severely impacting daily activities such as self-care and feeding skills.

This study will test the hypothesis that a single session of acute intermittent hypoxia will increase strength and activation of the trunk muscles that control respiration and posture, leading to improved scores on functional assessments in individuals with chronic spinal cord injury. Our long term goal is to better understand the therapeutic potential of acute intermittent hypoxia combined with physical rehabilitation for individuals with chronic spinal cord injury.

Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Single (Participant)
Masking Description:
Subjects will be asked to participate in two visits at least 7 days apart. Subjects will be assessed on various clinical outcomes before and after an exposure to one of two treatments. In one visit, subjects will be assessed before and after acute intermittent hypoxia, consisting of brief exposures of breathing low oxygen air, alternated with brief exposures to room air. In the other visit, subjects will be assessed before and after an exposure to a sham treatment, consisting of breathing brief exposures of normal oxygen air, alternated with brief exposures to room air. Subjects will undergo acute intermittent hypoxia or a sham treatment in a randomized order.
Primary Purpose: Treatment
Condition  ICMJE Spinal Cord Injuries
Intervention  ICMJE
  • Device: Hypoxico Hyp-123
    During acute intermittent hypoxia, subjects will undergo 15 brief exposures (60-120 seconds) of low oxygen air (9-15% inspired oxygen) delivered by an air generator, alternated with 15 brief exposures (60-120 seconds) of ambient room air.
    Other Name: Altitude Generator
  • Device: Hypoxico Hyp-123
    During sham intermittent hypoxia, subjects will undergo 15 brief exposures (60-120 seconds) of normal oxygen air (21% inspired oxygen) delivered by an air generator, alternated with 15 brief exposures (60-120 seconds) of ambient room air.
    Other Name: Altitude Generator
Study Arms  ICMJE
  • Active Comparator: Acute Intermittent Hypoxia
    Subjects with chronic spinal cord injury will undergo an acute intermittent hypoxia protocol with low oxygen air (9-15% inspired oxygen.
    Intervention: Device: Hypoxico Hyp-123
  • Sham Comparator: Sham Intermittent Hypoxia
    Subjects with chronic spinal cord injury will undergo a sham placebo protocol with normal oxygen air (21% inspired oxygen).
    Intervention: Device: Hypoxico Hyp-123
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: March 21, 2018)
35
Original Estimated Enrollment  ICMJE
 (submitted: March 3, 2017)
30
Estimated Study Completion Date  ICMJE March 2021
Estimated Primary Completion Date March 2021   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion criteria:

  1. Male or female, ages 18-65
  2. Greater than 6 months post-spinal cord injury
  3. Spinal cord injury affecting segments between C4-T12
  4. No other known neurological disorders
  5. Able to provide informed consent
  6. no severe musculoskeletal impairments, open wounds, or skin lesions that would limit participation in functional assessments.

Exclusion criteria:

  1. Presence of a self-reported uncontrolled medical condition including, but not limited to: cardiovascular disease; sleep apnea; obstructive lung disease; severe neuropathic or chronic pain; severe recurrent autonomic dysreflexia
  2. Severe, untreated bladder or urinary tract infection
  3. Presence of severe musculoskeletal impairments, open wounds, or skin lesions that would limit participation in functional assessments
  4. Women who report being pregnant or test positive on a pregnancy test
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 65 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Thomas W. Sutor, MS (352) 273-6117 tsutor@ufl.edu
Contact: Emily J. Fox, PT, DPT, PhD (352) 273-6117 ejfox@phhp.ufl.edu
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03071393
Other Study ID Numbers  ICMJE IRB201601680
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Product Manufactured in and Exported from the U.S.: Yes
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party University of Florida
Study Sponsor  ICMJE University of Florida
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Emily J Fox, PT, DPT, PhD University of Florida
PRS Account University of Florida
Verification Date March 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP