Spinal Cord Injury
Conditions
Keywords
spinal cord injury
Brief summary
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.
Interventions
DEVICEMotorized bicycle exercise training
Passive exercise with a bicycle to bilateral legs. 5 days per week for 3 months
Sponsors
University of Arkansas
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
Yes
Inclusion criteria
* 1\. An incomplete spinal cord injury at a level of C4 to T12. * 2\. 18 to 70 years of age.
Exclusion criteria
* 1\. Joint contractures and/or spasticity that would hamper upright posture or use of MBET * 2\. A documented blood clot in the lower extremities * 3\. A history of lower extremity fractures (excludes randomization to the PWBT). * 4\. Pregnant women
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Muscle Mass Via Dual-Energy X-ray Absortiometry (DEXA)Scan Data | baseline and 3 months | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Bone Density Via Dual-Energy X-ray Absortiometry (DEXA) Scan | baseline and 3 months Post-exercise | 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. |
Countries
United States
Participant flow
Recruitment details
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
Pre-assignment details
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.
Participants by arm
| Arm | Count |
|---|---|
| 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. | 17 |
| Total | 17 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Physician Decision | 5 |
Baseline characteristics
| Characteristic | Passive Exercise With Motorized Bicycle |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 0 Participants |
| Age, Categorical Between 18 and 65 years | 17 Participants |
| Age Continuous | 35.38 years STANDARD_DEVIATION 14.4314 |
| Region of Enrollment United States | 17 participants |
| Sex: Female, Male Female | 4 Participants |
| Sex: Female, Male Male | 13 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 0 / 12 |
| serious Total, serious adverse events | 0 / 12 |
Outcome results
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.
Time frame: baseline and 3 months
Population: analysis per protocol
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Passive Exercise With Motorized Bicycle | Muscle Mass Via Dual-Energy X-ray Absortiometry (DEXA)Scan Data | Baseline | 6104.45 grams | Standard Deviation 1087.6 |
| Passive Exercise With Motorized Bicycle | Muscle Mass Via Dual-Energy X-ray Absortiometry (DEXA)Scan Data | Post exercise | 6355.3 grams | Standard Deviation 1667.8 |
Comparison: Paired samples T-test was used to assess the statisical changes between baseline and post-exercise lean muscle mass.p-value: 0.31895% CI: [-778.87, 277.21]t-test, 2 sided
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.
Time frame: baseline and 3 months Post-exercise
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Passive Exercise With Motorized Bicycle | Bone Density Via Dual-Energy X-ray Absortiometry (DEXA) Scan | Baseline | 1.134 grams/cm^2 | Standard Deviation 0.29041 |
| Passive Exercise With Motorized Bicycle | Bone Density Via Dual-Energy X-ray Absortiometry (DEXA) Scan | 3 months post exercise | 1.069 grams/cm^2 | Standard Deviation 0.25988 |
Comparison: Paired samples T-test was used to assess the statisical changes between baseline and post-exercise bone density.p-value: 0.01195% CI: [0.01827, 0.11073]t-test, 2 sided