NCT03833674

FLO2 for Recovery After SCI

Acute Intermittent Hypoxia and Respiratory Strength Training to Improve Breathing Function After Spinal Cord Injury

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 43 (actual)
• Sponsor: University of Florida · Academic / Other
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Spinal Cord Injury (SCI)

Interventions

Type	Name	Description
OTHER	Daily AIH Block	Daily sessions of AIH (dAIH) with use of short episodes of low oxygen (9% O2)
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.

Timeline

• Start date: 2020-08-15
• Primary completion: 2024-02-20
• Completion: 2024-02-20
• First posted: 2019-02-07
• Last updated: 2024-05-29

Locations

1 site across 1 country: United States