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| ID | Type | Description | Link |
|---|---|---|---|
| PRN # 12903 NIH |
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Spinal cord injury (SCI) leads to muscle atrophy, hyperreflexia and spasticity, symptoms that decrease quality of life and prevent effective rehabilitation. Previous findings from our labs found that a passive cycling exercise program, motorized bicycle exercise training (MBET), in adult spinally transected animals reduced muscle atrophy and normalized hyperreflexia. We found that MBET could prevent the onset of hyperreflexia after spinal transaction, that MBET could also be used to rescue from hyperreflexia once it had set in, and that MBET could induce savings in normalization of reflexes after MBET ceased. We also demonstrated that MBET was effective in rescuing from hyperreflexia in a chronic ASIA B SCI patient, and that short-term MBET could lead to brief savings in normalization of reflexes once MBET ceased. The proposed studies will test the ability to MBET to prevent the onset of hyperreflexia in a group of acute SCI patients trained before hyperreflexia has had a chance to set in. In addition, the proposed research will attempt to confirm the possibility that long-term MBET in chronic SCI patients will rescue from hyperreflexia once it has set in, and also produce significant savings in normalization of reflexes if carried out for long periods of time. We will also test the possibility that MBET in acute and/or chronic SCI patients could reduce or prevent muscle atrophy. The experimental design calls for assessing muscle mass using MRI scans, bone density using Dual-Energy X-ray Absortiometry (DEXA) scans, spasticity measures and electrophysiological measurements to determine low frequency habituation of the H-reflex. Assessments will be carried out before MBET, during a 25 week MBET block of time, and during a 12 week post MBET monitoring period. Changes in muscle mass, bone density, spasticity scales and H-reflex habituation will be compared across these interventions and between treated SCI victims and a group of control acute and chronic SCI victims undergoing standard of care during the same period.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| A | Experimental | Exercise group |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Motorized bicycle exercise training | Device | Passive exercise with a bicycle to bilateral legs. 5 days per week for 3 months |
|
| Measure | Description | Time Frame |
|---|---|---|
| Muscle Mass Via Dual-Energy X-ray Absortiometry (DEXA)Scan Data | Lean muscle mass was measured with Dual-Energy X-ray Absortiometry (DEXA) scan, which uses low dose radiation to assess bone density and soft tissue density. pre and post, three month exercise protocol on a passivie motorized exercise bicycle. | baseline and 3 months |
| Measure | Description | Time Frame |
|---|---|---|
| Bone Density Via Dual-Energy X-ray Absortiometry (DEXA) Scan | Bone mineral density was measured with Dual-Energy X-ray Absortiometry (DEXA) scan pre and post, three month exercise protocol on a passive motorized exercise bicycle. | baseline and 3 months Post-exercise |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Thomas S. Kiser, MD | Center for Translational Neuroscience, UAMS | Principal Investigator |
| Edgar Garcia-Rill, PhD | Center for Translational Neuroscience, UAMS | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Center for Translational Neuroscience #847 | Little Rock | Arkansas | 72205 | United States |
Patients were excluded from the study if we were unable to obtain an H-reflex on nerve conduction study due to this being the primary endpoint we were assessing.
Patients recruited from my outpatient and inpatient clinical service who had a spinal cord injury starting on 4/1/2003 and ending on 3/9/2010
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| ID | Title | Description |
|---|---|---|
| FG000 | Passive Exercise With Motorized Bicycle | The exercise was conducted from the subjects wheelchair with the feet attached to the bicycle by velcro straps and extra ankle dorsiflexion, provided by wedges on the pedal, to stretch the gastrocnemeus and soleus muscles. 60 minutes of exercise at with a goal of 60 rpm per training session. The exercise was conducted three times a week for 16 weeks or 5 times a week for 12 weeks, for an average of 50 sessions. Each subjects bone density and lean muscle mass was measured by DEXA scan, using a low radiation dose to determine the effect of exercise by comparing the subjects change in both parameters before the exercise and then after the exercise. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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| ID | Title | Description |
|---|---|---|
| BG000 | Passive Exercise With Motorized Bicycle | The exercise was conducted from the subjects wheelchair with the feet attached to the bicycle by velcro straps and extra ankle dorsiflexion, provided by wedges on the pedal, to stretch the gastrocnemeus and soleus muscles. 60 minutes of exercise at with a goal of 60 rpm per training session. The exercise was conducted three times a week for 16 weeks or 5 times a week for 12 weeks, for an average of 50 sessions. Each subjects bone density and lean muscle mass was measured by DEXA scan, using a low radiation dose to determine the effect of exercise by comparing the subjects change in both parameters before the exercise and then after the exercise. |
| 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 | Muscle Mass Via Dual-Energy X-ray Absortiometry (DEXA)Scan Data | Lean muscle mass was measured with Dual-Energy X-ray Absortiometry (DEXA) scan, which uses low dose radiation to assess bone density and soft tissue density. pre and post, three month exercise protocol on a passivie motorized exercise bicycle. | analysis per protocol | Posted | Mean | Standard Deviation | grams | baseline and 3 months |
|
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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 | Passive Exercise With Motorized Bicycle | The exercise was conducted from the subjects wheelchair with the feet attached to the bicycle by velcro straps and extra ankle dorsiflexion, provided by wedges on the pedal, to stretch the gastrocnemeus and soleus muscles. 60 minutes of exercise at with a goal of 60 rpm per training session. The exercise was conducted three times a week for 16 weeks or 5 times a week for 12 weeks, for an average of 50 sessions. Each subjects bone density and lean muscle mass was measured by DEXA scan, using a low radiation dose to determine the effect of exercise by comparing the subjects change in both parameters before the exercise and then after the exercise. |
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This was a pilot study to determine if a passive exercise bicycle would suppress the H-reflex after a spinal cord injury. We were not able to collect stable H-reflex data. However, the Dual-Energy X-ray Absortiometry (DEXA) scan data was useable.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Thomas S. Kiser | Dept of PM&R; University of Arkansas for Medical Sciences | 501-221-1311 | kiserthomass@uams.edu |
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| ID | Term |
|---|---|
| D013119 | Spinal Cord Injuries |
| ID | Term |
|---|---|
| D013118 | Spinal Cord Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D020196 | Trauma, Nervous System |
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| Participants |
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| Age Continuous | Mean | Standard Deviation | years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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| Secondary | Bone Density Via Dual-Energy X-ray Absortiometry (DEXA) Scan | Bone mineral density was measured with Dual-Energy X-ray Absortiometry (DEXA) scan pre and post, three month exercise protocol on a passive motorized exercise bicycle. | Posted | Mean | Standard Deviation | grams/cm^2 | baseline and 3 months Post-exercise |
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| 0 |
| 12 |
| 0 |
| 12 |
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| D014947 | Wounds and Injuries |