FLO2 for Recovery After SCI
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The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. |
| ClinicalTrials.gov Identifier: NCT03833674 |
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Recruitment Status :
Recruiting
First Posted : February 7, 2019
Last Update Posted : November 5, 2021
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| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Spinal Cord Injury (SCI) | Other: Daily AIH Block Other: Sham dAIH Block Other: Respiratory Strength Training Block Other: AIH + Strength Training Block | Not Applicable |
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.
| Study Type : | Interventional (Clinical Trial) |
| Estimated Enrollment : | 53 participants |
| Allocation: | N/A |
| Intervention Model: | Single Group Assignment |
| Intervention 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. |
| Primary Purpose: | Treatment |
| Official Title: | Acute Intermittent Hypoxia and Respiratory Strength Training to Improve Breathing Function After Spinal Cord Injury |
| Actual Study Start Date : | August 15, 2020 |
| Estimated Primary Completion Date : | January 2022 |
| Estimated Study Completion Date : | April 2022 |
| Arm | Intervention/treatment |
|---|---|
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Experimental: Adults with incomplete SCI
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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Other: Daily AIH Block
Daily sessions of AIH (dAIH) with use of short episodes of low oxygen (9% O2)
Other Name: dAIH Block 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. |
- Change in maximal inspiratory pressure [ Time Frame: Baseline, Day 1, Day 6, Day 8, Day 15 ]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 [ Time Frame: Baseline, Day 1, Day 6, Day 8, Day 15 ]Maximal expiratory pressure is a non-invasive measure of the maximal force generated when breathing out against an occluded airway.
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
| Ages Eligible for Study: | 18 Years to 70 Years (Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
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
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03833674
| Contact: Alicia Vose, MA CCC-SLP | 860-912-8156 | avose1@ufl.edu | |
| Contact: Emily J Fox, DPT, PhD | ejfox@ufl.edu |
| United States, Florida | |
| Brooks Rehabilitation Hospital | Recruiting |
| Jacksonville, Florida, United States, 32216 | |
| Contact: Lou DeMark, DPT 904-345-8968 lou.demark@brooksrehab.org | |
| Principal Investigator: | Emily Fox, PT, PhD | University of Florida | |
| Principal Investigator: | Gordon Mitchell, PhD | University of Florida |
| Responsible Party: | University of Florida |
| ClinicalTrials.gov Identifier: | NCT03833674 |
| Other Study ID Numbers: |
IRB201802672 W81XWH-18-1-0718 ( Other Grant/Funding Number: US Deptartment of Defense ) |
| First Posted: | February 7, 2019 Key Record Dates |
| Last Update Posted: | November 5, 2021 |
| Last Verified: | November 2021 |
| Individual Participant Data (IPD) Sharing Statement: | |
| Plan to Share IPD: | No |
| Studies a U.S. FDA-regulated Drug Product: | No |
| Studies a U.S. FDA-regulated Device Product: | No |
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acute intermittent hypoxia (AIH) spinal neuroplasticity motor function respiratory strength training |
respiration breathing plasticity |
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Spinal Cord Injuries Spinal Cord Diseases Central Nervous System Diseases |
Nervous System Diseases Trauma, Nervous System Wounds and Injuries |