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| ID | Type | Description | Link |
|---|---|---|---|
| W81XWH-18-1-0718 | Other Grant/Funding Number | US Deptartment of Defense |
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| Name | Class |
|---|---|
| United States Department of Defense | FED |
| Brooks Rehabilitation | OTHER |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Adults with incomplete SCI | Experimental | 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). |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Daily AIH Block | Other | Daily sessions of AIH (dAIH) with use of short episodes of low oxygen (9% O2) |
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| Measure | Description | Time Frame |
|---|---|---|
| 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. | Baseline, Day 1, Day 6, Day 8, Day 15 |
| 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. | Baseline, Day 1, Day 6, Day 8, Day 15 |
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Inclusion Criteria:
-OR-
Chronic complete SCI for ≥ 1 year at or below C-4 to T-12
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Emily Fox, PT, PhD | University of Florida | Principal Investigator |
| Gordon Mitchell, PhD | University of Florida | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Brooks Rehabilitation Hospital | Jacksonville | Florida | 32216 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 38468543 | Derived | Welch JF, Vose AK, Cavka K, Brunetti G, DeMark LA, Snyder H, Wauneka CN, Tonuzi G, Nair J, Mitchell GS, Fox EJ. Cardiorespiratory Responses to Acute Intermittent Hypoxia in Humans With Chronic Spinal Cord Injury. J Neurotrauma. 2024 Sep;41(17-18):2114-2124. doi: 10.1089/neu.2023.0353. Epub 2024 Apr 18. |
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| ID | Term |
|---|---|
| D013119 | Spinal Cord Injuries |
| D053120 | Respiratory Aspiration |
| ID | Term |
|---|---|
| D013118 | Spinal Cord Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D020196 | Trauma, Nervous System |
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| ID | Term |
|---|---|
| D007317 | Insemination, Artificial, Homologous |
| ID | Term |
|---|---|
| D007315 | Insemination, Artificial |
| D027724 | Reproductive Techniques, Assisted |
| D012099 | Reproductive Techniques |
| D013812 | Therapeutics |
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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.
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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.
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| Sham dAIH Block | Other | Daily sessions of sham dAIH which includes breathing room air (21% O2) |
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| Respiratory Strength Training Block | Other | Respiratory strength training using a hand-held device that resists inspiration or expiration. |
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| AIH + Strength Training Block | Other | AIH followed by respiratory strength training. |
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| D014947 | Wounds and Injuries |
| D012120 | Respiration Disorders |
| D012140 | Respiratory Tract Diseases |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D008919 | Investigative Techniques |
| D007314 | Insemination |
| D012098 | Reproduction |
| D055703 | Reproductive Physiological Phenomena |
| D012101 | Reproductive and Urinary Physiological Phenomena |