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| Name | Class |
|---|---|
| University of Florida | OTHER |
| Wayne State University | OTHER |
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Change to Reflect What Was Done and reason Changes Were Made.
The purpose of this study is to determine (1) if a specific breathing treatment (intermittent hypoxia) can promote changes in breathing function and (2) if pairing breathing treatments (hypoxia) with locomotor training can enhance the benefits of walking recovery observed with locomotor training alone (without breathing treatments).
Spinal cord injury (SCI) is a very disabling health problem. Paralysis and paresis of limb and trunk muscles are major consequences of SCI and result in the inability to walk or difficulty walking. The most commonly stated goal by individuals with SCI during rehabilitation is the desire to walk again. Locomotor training (LT) that uses a body-weight support system and treadmill (BWST) is a task-specific rehabilitation intervention that allows practice of walking at normal speeds while loading the lower extremities, facilitating upright posture, and hip extension. Substantial improvement in ambulation can occur following locomotor training (LT) in individuals with motor incomplete spinal cord injury (iSCI). Despite these advances in activity-dependent rehabilitation, a need exists for defining complementary strategies that further amplify endogenous neuroplasticity. The proposed study will assess the therapeutic potential of (1) a respiratory training intervention (acute intermittent hypoxia, or AIH) on breathing function and (2) a combined locomotor (LT) and respiratory (AIH) training intervention for enhancing walking recovery.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Phase 1 Arm (Pilot) | Experimental | Individuals were exposed to intermittent hypoxia and locomotor training to establish our interventions (set up lab, train personnel, develop study protocols/interventions, etc) |
|
| Phase 2 Arm (LTF) | Experimental | Individuals were exposed to 10 days of intermittent hypoxia to determine the effect of this intervention on ventilatory long-term facilitation, as measured by minute ventilation |
|
| Phase 3 Arm (Ventilatory Loading) | Other | Individuals were exposed to 10 days of intermittent hypoxia to determine changes in ventilatory loading. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Intermittent Hypoxia | Other | Individuals received exposure to intermittent hypoxia for 10 days, and placebo for 1-2 days. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Minute Ventilation - Phase 2 | Minute ventilation (Ve) is the volume of gas inhaled or exhaled from a person's lungs per minute. Minute ventilation during the end-recovery (ER) period at initial (i.e., Days 1 and 2, initial ER period) and final (i.e., Days 9 and 10, final ER period) days of the IH protocol were normalized to values from baseline with elevated carbon dioxide (B2) within each individual session to characterize daily effects of exposure to IH at the beginning and end of treatment. Values from baseline with elevated carbon dioxide and the ER period during the final days of the protocol (final B2 and final ER period, respectively) also were normalized to elevated carbon dioxide baseline during initial days of the protocol (initial B2) to describe the cumulative effects of repeated exposure to IH. Outcomes are reported as % increases in minute ventilation during initial and final treatment sessions for daily/acute effects and cumulative/chronic effects. | Pre- versus Post-treatment |
| Measure | Description | Time Frame |
|---|---|---|
| Ventilatory Loading - Phase 3 | Ventilatory load compensation was assessed in two ways. Mean slopes for (1) pressure vs. resistance (P vs R) and (2) airflow vs. resistance (AF vs R) were calculated for pre- and post-IH treatment. | Pre- versus Post-treatment |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Nicole J Tester, PhD | North Florida/South Georgia Veterans Health System | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| North Florida/South Georgia Veterans Health System | Gainesville | Florida | 32608 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 24224903 | Derived | Tester NJ, Fuller DD, Fromm JS, Spiess MR, Behrman AL, Mateika JH. Long-term facilitation of ventilation in humans with chronic spinal cord injury. Am J Respir Crit Care Med. 2014 Jan 1;189(1):57-65. doi: 10.1164/rccm.201305-0848OC. |
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Different study arms were carried out in different phases. The time individuals were enrolled determined which arm they were involved with. Participants enrolling knew which arm we currently were recruiting for. Individuals enrolled in early arms were invited back to other arms of the study if they chose--however, this was not a requirement.
Recruitment occurred from October, 2010 through April, 2014 through the North Florida/South Georgia VA Medical Center's Brain Rehabilitation Research Center.
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| ID | Title | Description |
|---|---|---|
| FG000 | Phase 1 Arm (Pilot) | This group of participants were exposed to intermittent hypoxia and/or locomotor training. They were enrolled only to establish and streamline the protocol and train the laboratory personnel. |
| FG001 | Phase 2 Arm (LTF) | This group of subjects were exposed to intermittent hypoxia and minute ventilation was recorded to determine whether ventilatory long term facilitation (LTF) was present. |
| FG002 | Phase 3 Arm (Ventilatory Loading) | This group of subjects was exposed to intermittent hypoxia and ventilatory loading was assessed. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Phase 1 Arm (Pilot) | This group of participants were exposed to intermittent hypoxia and/or locomotor training. They were enrolled only to establish and streamline the protocol and train the laboratory personnel. |
| BG001 | Phase 2 Arm (Long Term Facilitation) |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Minute Ventilation - Phase 2 | Minute ventilation (Ve) is the volume of gas inhaled or exhaled from a person's lungs per minute. Minute ventilation during the end-recovery (ER) period at initial (i.e., Days 1 and 2, initial ER period) and final (i.e., Days 9 and 10, final ER period) days of the IH protocol were normalized to values from baseline with elevated carbon dioxide (B2) within each individual session to characterize daily effects of exposure to IH at the beginning and end of treatment. Values from baseline with elevated carbon dioxide and the ER period during the final days of the protocol (final B2 and final ER period, respectively) also were normalized to elevated carbon dioxide baseline during initial days of the protocol (initial B2) to describe the cumulative effects of repeated exposure to IH. Outcomes are reported as % increases in minute ventilation during initial and final treatment sessions for daily/acute effects and cumulative/chronic effects. | Posted | Mean | Standard Error | percentage of baseline | Pre- versus Post-treatment |
|
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Phase 1 Arm (Pilot) | This group of participants were exposed to intermittent hypoxia and/or locomotor training. They were enrolled only to establish and streamline the protocol and train the laboratory personnel. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Nicole Tester | Malcom Randall VAMC | 352-376-1611 | 7507 | ntester@phhp.ufl.edu |
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| ID | Term |
|---|---|
| D013119 | Spinal Cord Injuries |
| D020210 | Central Cord Syndrome |
| 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 |
|---|---|
| D012138 | Respiratory Therapy |
| ID | Term |
|---|---|
| D013812 | Therapeutics |
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|
| Locomotor Training | Other | Individuals received 10 days of locomotor training, intense walking training on a treadmill with body weight support. Manual assistance was provided at the legs to optimize stepping patterns. |
|
This group of subjects were exposed to intermittent hypoxia and minute ventilation was recorded to determine whether ventilatory long term facilitation (LTF) was present. |
| BG002 | Phase 3 Arm (Ventilatory Loading) | This group of subjects was exposed to intermittent hypoxia and ventilatory loading was assessed. |
| BG003 | Total | Total of all reporting groups |
| Participants |
|
| Age, Continuous | Mean | Full Range | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Phase 1 Arm (Pilot) |
Individuals were exposed to intermittent hypoxia and locomotor training to establish our interventions (set up lab, train personnel, develop study protocols/interventions, etc) Intermittent Hypoxia: Individuals received exposure to intermittent hypoxia for 10 days, and placebo for 1-2 days. Locomotor Training: Individuals received 10 days of locomotor training, intense walking training on a treadmill with body weight support. Manual assistance was provided at the legs to optimize stepping patterns. |
| OG001 | Phase 2 Arm (LTF) | Individuals were exposed to 10 days of intermittent hypoxia to determine the effect of this intervention on ventilatory long-term facilitation, as measured by minute ventilation. Intermittent Hypoxia: Individuals received exposure to intermittent hypoxia for 10 days, and placebo for 1-2 days. |
| OG002 | Phase 3 Arm (Ventilatory Loading) | Individuals were exposed to 10 days of intermittent hypoxia to determine changes in ventilatory loading. Intermittent Hypoxia: Individuals received exposure to intermittent hypoxia for 10 days, and placebo for 1-2 days. |
|
|
|
| Secondary | Ventilatory Loading - Phase 3 | Ventilatory load compensation was assessed in two ways. Mean slopes for (1) pressure vs. resistance (P vs R) and (2) airflow vs. resistance (AF vs R) were calculated for pre- and post-IH treatment. | Data were collected from 3 participants. However, clinical observations revealed results of interest from only 1/3 of the participants. Therefore, data from only this 1 individual were analyzed for presentation as a case study. The data from the other 2 participants were not analyzed. | Posted | Mean | Standard Error | unitless | Pre- versus Post-treatment |
|
|
|
|
| 0 |
| 3 |
| 0 |
| 3 |
| EG001 | Phase 2 Arm (Long Term Facilitation) | This group of subjects were exposed to intermittent hypoxia and minute ventilation was recorded to determine whether ventilatory long term facilitation (LTF) was present. | 0 | 10 | 0 | 10 |
| EG002 | Phase 3 Arm (Ventilatory Loading) | This group of subjects was exposed to intermittent hypoxia and ventilatory loading was assessed. | 0 | 3 | 0 | 3 |
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| D014947 | Wounds and Injuries |
| D012120 | Respiration Disorders |
| D012140 | Respiratory Tract Diseases |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| Title | Measurements |
|---|---|
|
| AF vs R Post Day 10 IH |
|
| RMANOVA and Student-Neuman-Keuls |
| <0.05 |
| 2-Sided |
| No |
| Superiority or Other |