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FLO2 for Recovery After SCI

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ClinicalTrials.gov Identifier: NCT03833674
Recruitment Status : Not yet recruiting
First Posted : February 7, 2019
Last Update Posted : February 7, 2019
Sponsor:
Collaborators:
United States Department of Defense
Brooks Rehabilitation
Information provided by (Responsible Party):
University of Florida

Brief Summary:
Acute intermittent hypoxia (AIH) involves short (~1-2min) bouts of breathing low oxygen air to stimulate spinal neuroplasticity. Studies in rodents and humans indicate that AIH improves motor function after spinal cord injury (SCI). This study will use a double blind, cross-over design to test if the combination of AIH and respiratory strength training improves breathing function more than either approach alone in adults with chronic SCI.

Condition or disease Intervention/treatment Phase
Spinal Cord Injury (SCI) Other: Daily AIH Block Other: Sham dAIH Block Other: Respiratory Strength Training Block Other: AIH + Strength Training Block Not Applicable

Detailed Description:

Spinal cord injury (SCI) disrupts neural pathways to respiratory motor neurons, causing muscle paralysis and decreased breathing capacity. Since respiratory impairment is the major cause of illness and death with SCI, it is critical to devise new strategies to restore breathing function.

Repetitive exposure to brief episodes of low oxygen (acute intermittent hypoxia or AIH) has demonstrated to increase respiratory function in humans with chronic SCI. Additionally pre-clinical studies demonstrate that AIH-induced functional benefits are enhanced by combining AIH with task-specific training. The investigator's central hypothesis is that combined daily AIH (dAIH) and respiratory strength training will elicit greater and more sustained gains in respiratory function than either treatment alone in people with chronic SCI.

This study is a double-blind, randomized, cross-over design where participants will complete 4 random-ordered blocks, consisting of a 5-day intervention followed by a 3-week washout period, during which 1-day, 3-day, and 1-week post-tests will be conducted. Participants will include 53 adults with chronic, incomplete SCI with >20% respiratory impairment based on maximal inspiratory or expiratory pressure generation.


Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 53 participants
Intervention Model: Single Group Assignment
Intervention Model Description: Participants will complete a battery of clinical assessments and 4 randomly ordered intervention and testing blocks. Blocks 1, 2 and 3 include a 5 day intervention (e.g., dAIH and/or respiratory training) or sham protocol, followed by a 3-week washout period, with follow up measurements at 1 day, 3 days and 1 week post-intervention. The final block includes a 5-day protocol followed by 1-day, 3-day and 1-week post-tests.
Masking: None (Open Label)
Masking Description: Participants and the clinical evaluator will be informed of possible interventions but will be blinded to the gas mixture (hypoxic vs normoxic air) used during each AIH intervention.
Primary Purpose: Treatment
Official Title: Acute Intermittent Hypoxia and Respiratory Strength Training to Improve Breathing Function After Spinal Cord Injury
Estimated Study Start Date : May 2019
Estimated Primary Completion Date : January 2022
Estimated Study Completion Date : April 2022

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Adults with incomplete SCI
Adults with chronic, incomplete SCI who have >20% impairment in respiratory function, who will complete a battery of clinical assessments and 4 randomly ordered intervention and testing blocks (Daily AIH Block, Sham dAIH Block, Respiratory Strength Training Block and AIH + Strength Training Block).
Other: Daily AIH Block
Daily sessions of AIH (dAIH) with use of short episodes of low oxygen (9% O2)
Other Name: dAIH Block

Other: Sham dAIH Block
Daily sessions of sham dAIH which includes breathing room air (21% O2)

Other: Respiratory Strength Training Block
Respiratory strength training using a hand-held device that resists inspiration or expiration.

Other: AIH + Strength Training Block
AIH followed by respiratory strength training.




Primary Outcome Measures :
  1. Change in maximal inspiratory pressure [ Time Frame: Baseline, Day 1, Day 6, Day 8, Day 15 ]
    Maximal inspiratory pressure is a non-invasive measure of the maximal force achieved when breathing in against an occluded airway.

  2. Change in maximal expiratory pressure [ Time Frame: Baseline, Day 1, Day 6, Day 8, Day 15 ]
    Maximal expiratory pressure is a non-invasive measure of the maximal force generated when breathing out against an occluded airway.



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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Chronic incomplete SCI for ≥ 1 year at or below C-3 to T-12
  • Incomplete SCI based on residual sensory and motor function below the level of the injury or injury classification of B, C, D at initial screening according to the American Spinal Injury Association Impairment Classification and the International Standards for the Neurological Classification of SCI.
  • Medically stable with clearance from physician
  • SCI due to non-progressive etiology
  • >20% impairment in maximal inspiratory or expiratory pressure generation, relative to established normative values.

Exclusion Criteria:

  • Current diagnosis of an additional neurologic condition such as multiple sclerosis, Parkinson's disease, stroke, or brain injury
  • Presence of unstable or uncontrolled medical conditions such as cardiovascular disease, myocardial infarction, <1 year lung disease, infections, hypertension, heterotopic ossification.
  • Severe neuropathic pain
  • Known pregnancy
  • Severe recurrent autonomic dysreflexia
  • History of seizure disorder < 1 year

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03833674


Contacts
Contact: Alicia Vose, MA CCC-SLP 860-912-8156 avose1@ufl.edu
Contact: Emily J Fox, DPT, PhD ejfox@ufl.edu

Locations
United States, Florida
Brooks Rehabilitation Hospital Not yet recruiting
Jacksonville, Florida, United States, 32216
Contact: Lou DeMark, DPT    904-345-8968    lou.demark@brooksrehab.org   
Sponsors and Collaborators
University of Florida
United States Department of Defense
Brooks Rehabilitation
Investigators
Principal Investigator: Emily Fox, PT, PhD University of Florida
Principal Investigator: Gordon Mitchell, PhD University of Florida

Responsible Party: University of Florida
ClinicalTrials.gov Identifier: NCT03833674     History of Changes
Other Study ID Numbers: IRB201802672
W81XWH-18-1-0718 ( Other Grant/Funding Number: US Deptartment of Defense )
First Posted: February 7, 2019    Key Record Dates
Last Update Posted: February 7, 2019
Last Verified: February 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by University of Florida:
acute intermittent hypoxia (AIH)
spinal neuroplasticity
motor function
respiratory strength training
respiration
breathing
plasticity

Additional relevant MeSH terms:
Spinal Cord Injuries
Spinal Cord Diseases
Central Nervous System Diseases
Nervous System Diseases
Trauma, Nervous System
Wounds and Injuries