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FLO2 for Recovery After SCI

Primary Purpose

Spinal Cord Injury (SCI)

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Daily AIH Block
Sham dAIH Block
Respiratory Strength Training Block
AIH + Strength Training Block
Sponsored by
University of Florida
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Spinal Cord Injury (SCI) focused on measuring acute intermittent hypoxia (AIH), spinal neuroplasticity, motor function, respiratory strength training, respiration, breathing, plasticity

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Chronic incomplete SCI for ≥ 1 year at or below C-1 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

-OR-

Chronic complete SCI for ≥ 1 year at or below C-4 to T-12

  • Complete SCI based on the absence of residual sensory or motor function below the level of injury or injury classification of A 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

Sites / Locations

  • Brooks Rehabilitation HospitalRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Adults with incomplete SCI

Arm Description

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).

Outcomes

Primary Outcome Measures

Change in maximal inspiratory pressure
Maximal inspiratory pressure is a non-invasive measure of the maximal force achieved when breathing in against an occluded airway.
Change in maximal expiratory pressure
Maximal expiratory pressure is a non-invasive measure of the maximal force generated when breathing out against an occluded airway.

Secondary Outcome Measures

Full Information

First Posted
February 6, 2019
Last Updated
September 8, 2023
Sponsor
University of Florida
Collaborators
United States Department of Defense, Brooks Rehabilitation
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1. Study Identification

Unique Protocol Identification Number
NCT03833674
Brief Title
FLO2 for Recovery After SCI
Official Title
Acute Intermittent Hypoxia and Respiratory Strength Training to Improve Breathing Function After Spinal Cord Injury
Study Type
Interventional

2. Study Status

Record Verification Date
September 2023
Overall Recruitment Status
Recruiting
Study Start Date
August 15, 2020 (Actual)
Primary Completion Date
September 2023 (Anticipated)
Study Completion Date
November 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Florida
Collaborators
United States Department of Defense, Brooks Rehabilitation

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Spinal Cord Injury (SCI)
Keywords
acute intermittent hypoxia (AIH), spinal neuroplasticity, motor function, respiratory strength training, respiration, breathing, plasticity

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
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.
Allocation
N/A
Enrollment
53 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Adults with incomplete SCI
Arm Type
Experimental
Arm Description
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).
Intervention Type
Other
Intervention Name(s)
Daily AIH Block
Other Intervention Name(s)
dAIH Block
Intervention Description
Daily sessions of AIH (dAIH) with use of short episodes of low oxygen (9% O2)
Intervention Type
Other
Intervention Name(s)
Sham dAIH Block
Intervention Description
Daily sessions of sham dAIH which includes breathing room air (21% O2)
Intervention Type
Other
Intervention Name(s)
Respiratory Strength Training Block
Intervention Description
Respiratory strength training using a hand-held device that resists inspiration or expiration.
Intervention Type
Other
Intervention Name(s)
AIH + Strength Training Block
Intervention Description
AIH followed by respiratory strength training.
Primary Outcome Measure Information:
Title
Change in maximal inspiratory pressure
Description
Maximal inspiratory pressure is a non-invasive measure of the maximal force achieved when breathing in against an occluded airway.
Time Frame
Baseline, Day 1, Day 6, Day 8, Day 15
Title
Change in maximal expiratory pressure
Description
Maximal expiratory pressure is a non-invasive measure of the maximal force generated when breathing out against an occluded airway.
Time Frame
Baseline, Day 1, Day 6, Day 8, Day 15

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Chronic incomplete SCI for ≥ 1 year at or below C-1 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 -OR- Chronic complete SCI for ≥ 1 year at or below C-4 to T-12 Complete SCI based on the absence of residual sensory or motor function below the level of injury or injury classification of A 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Alicia Vose, MA CCC-SLP
Phone
860-912-8156
Email
avose1@ufl.edu
First Name & Middle Initial & Last Name or Official Title & Degree
Emily J Fox, DPT, PhD
Email
ejfox@ufl.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Emily Fox, PT, PhD
Organizational Affiliation
University of Florida
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Gordon Mitchell, PhD
Organizational Affiliation
University of Florida
Official's Role
Principal Investigator
Facility Information:
Facility Name
Brooks Rehabilitation Hospital
City
Jacksonville
State/Province
Florida
ZIP/Postal Code
32216
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Lou DeMark, DPT
Phone
904-345-8968
Email
lou.demark@brooksrehab.org

12. IPD Sharing Statement

Plan to Share IPD
No

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FLO2 for Recovery After SCI

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