FLO2 for Recovery After SCI
| Status: | Not yet recruiting |
|---|---|
| Conditions: | Hospital |
| Therapuetic Areas: | Other |
| Healthy: | No |
| Age Range: | 18 - 65 |
| Updated: | 2/9/2019 |
| Start Date: | May 2019 |
| End Date: | April 2022 |
| Contact: | Alicia Vose, MA CCC-SLP |
| Email: | avose1@ufl.edu |
| Phone: | 860-912-8156 |
Acute Intermittent Hypoxia and Respiratory Strength Training to Improve Breathing Function After Spinal Cord Injury
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.
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.
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.
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.
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
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