FLO2 for Recovery After SCI

General health
Online since 8 November 2021, updated 891 days ago

About this trial

This is a trial to test the effect of repeatedly breathing air with low oxygen content for brief periods, alternating with breathing room air with normal oxygen content (acute intermittent hypoxia: AIH) combined with training breathing muscles to determine if their combined effect on breathing function is better than that achieved with either intervention alone. If included in this trial, the participant will complete 4x5-day interventions of 1) AIH, 2) breathing muscle strength training, 3) AIH and breathing muscle strength training, and 4) inactive intervention (sham AIH breathing room air) - not intended to have a therapeutic effect - used in a controlled trial for comparison to the active intervention. The order in which the interventions will be administered will be randomly determined. The intervention periods will be followed by a 3-week period without any intervention, during which clinical tests will be performed at 1 day, 3 days, and 1 week after the intervention.

Included participants

Gender
All
Age
18 - 65 years
Injury level
C3 - T12
  • Severity (AIS)?
  • AIS-B
    AIS-C
    AIS-D
    Time since injury
    1 year - 65 years
  • Injury type
  • Traumatic

    Non-traumatic

    Stenosis

    Spondylosis

    Healthy volunteers
    No
    C3-T12
    Additionally, participants must
    have a spinal cord injury for at least 1 year.
    have a neurological level of injury between C3 and T12.
    have one of the following ASIA impairment scale (AIS):

    What’s involved

    Type

    Observational

    Details

    Participants will participate in 4 randomly ordered 5-day interventions of 1) AIH, 2) breathing strength training, 3) AIH and breathing muscle strength training, and 4) inactive intervention (sham AIH). The intervention periods will each be followed by a 3-week period without any intervention, during which clinical tests will be performed at 1 day, 3 days, and 1 week after the intervention.

    Potential benefits

    Main benefits

    General health

    Additional benefits

    Good to know: Potential benefits are defined as outcomes that are being measured during and/or after the trial.

    Wings for Life supports SCITrialsFinder

    Wings for Life has proudly initiated, led and funded the new version of the SCI Trials Finder website. Wings for Life aims to find a cure for spinal cord injuries. The not-for-profit foundation funds world-class scientific research and clinical trials around the globe.

    Learn more

    • Trial recruitment status
    • Recruiting
    • Trial start date
    • 15 Aug 2020
    • Organisation
    • University of Florida
    • Trial recruitment status
    • Recruiting
    • Trial start date
    • 15 Aug 2020
    • Organisation
    • University of Florida

    Wings for Life supports SCITrialsFinder

    Wings for Life has proudly initiated, led and funded the new version of the SCI Trials Finder website. Wings for Life aims to find a cure for spinal cord injuries. The not-for-profit foundation funds world-class scientific research and clinical trials around the globe.

    Learn more