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| Name | Class |
|---|---|
| The Craig H. Neilsen Foundation | OTHER |
| Magee Rehabilitation Hospital | UNKNOWN |
| Temple University | OTHER |
| University of Delaware |
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Background:
People with spinal cord injury (SCI) are at risk for many health conditions, some of which can be decreased with exercise. Cycling with Functional Electrical Stimulation (FES) is one way to obtain exercise after SCI. However, cycling with FES has only been done one way, which involves pedaling more quickly with less force to work against. Pedaling more slowly would allow the person to work against more force, which may lead to greater improvements in bone mineral density and muscle size. It may also lead to greater changes in bone make-up, body fat, and cholesterol levels. All of these improvements may lead to a decrease in bone fractures and cardiovascular disease, two major medical issues that exist in the SCI population. Study Aims: This study will compare the outcomes on bone, muscle and cardiovascular health between the commonly used method of pedaling more quickly to a new method of pedaling more slowly. Both groups will work against the maximal force possible. It is expected that the group pedaling more slowly will work against greater force and thus will have improved outcomes compared to other group pedaling faster. Methods: Twenty people with SCI, ages 18-65 years, will be randomly assigned to a treatment group and will participate in three 60-minute sessions per week for 6 months at an outpatient rehabilitation center. All subjects must have complete paralysis of both legs, but may have sensation preserved. Before and after 6 months of exercise, subjects will have an MRI scan to assess muscle size and bone, a dexascan to assess bone, a strength test using electrical stimulation to assess muscle force, an analysis of fat free body tissue, and lab work to measure cholesterol, bone factors that provide insight into bone change, and nutritional status. Relevance: If the protocol of pedaling more slowly results in greater improvements, this technique can be applied to clinical practice. Some people with SCI have FES cycles in their homes and many have been cycling for many years. This new technique may allow them to obtain more benefits than what they currently are receiving from FES cycling. In addition, it is important to maintain overall bone, muscle and cardiovascular health so that people with SCI are health and ready when spinal cord regeneration becomes clinically available.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| High cadence, low resistance | Experimental | Subjects in this arm will cycle with functional electrical stimulation at a higher cadence (speed) and a lower resistance. |
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| Low cadence, high resistance | Experimental | Subjects in this arm will cycle with functional electrical stimulation at a lower cadence (speed) and a higher resistance. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Cycling with functional electrical stimulation | Other | Subjects will cycle with functional electrical stimulation for one hour, 3 times per week at Magee Rehab's outpatient center. Subjects will cycle for a total of 26 weeks (6 months). |
| Measure | Description | Time Frame |
|---|---|---|
| Bone density and bone microarchitecture | Bone is measured using dexascan and Magnetic Resonance Imaging (MRI) to examine different types of bone (cortical and trabecular). | Baseline |
| Bone density and bone microarchitecture | Bone is measured using dexascan and Magnetic Resonance Imaging (MRI) to examine different types of bone (cortical and trabecular). | 6 months |
| Muscle volume | Muscle volume is assessed using MRI | Baseline |
| Muscle volume | Muscle volume is assessed using MRI | 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| Muscle strength | Muscle strength is assessed by stimulating the muscle using a max twitch technique and measuring the isometric force output on a dynamometer. | Baseline |
| Muscle strength | Muscle strength is assessed by stimulating the muscle using a max twitch technique and measuring the isometric force output on a dynamometer. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Therese E Johnston, PT, PhD, MBA | Thomas Jefferson University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Magee Rehabilitation Hospital | Philadelphia | Pennsylvania | 19102 | United States | ||
| Thomas Jefferson University Hospital |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 26705884 | Derived | Johnston TE, Marino RJ, Oleson CV, Schmidt-Read M, Leiby BE, Sendecki J, Singh H, Modlesky CM. Musculoskeletal Effects of 2 Functional Electrical Stimulation Cycling Paradigms Conducted at Different Cadences for People With Spinal Cord Injury: A Pilot Study. Arch Phys Med Rehabil. 2016 Sep;97(9):1413-1422. doi: 10.1016/j.apmr.2015.11.014. Epub 2015 Dec 17. |
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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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| OTHER |
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| 3 months |
| Muscle strength | Muscle strength is assessed by stimulating the muscle using a max twitch technique and measuring the isometric force output on a dynamometer. | 6 months |
| Bone markers | Bone markers are assessed through blood and urine analysis. | baseline |
| Bone markers | Bone markers are assessed through blood and urine analysis. | 3 months |
| Bone markers | Bone markers are assessed through blood and urine analysis. | 6 months |
| Fat free soft tissue | Fat free mass is assessed using a bioimpedance monitor. | baseline |
| Fat free soft tissue | Fat free mass is assessed using a bioimpedance monitor. | 3 months |
| Fat free soft tissue | Fat free mass is assessed using a bioimpedance monitor. | 6 months |
| Philadelphia |
| Pennsylvania |
| 19107 |
| United States |
| Thomas Jefferson University | Philadelphia | Pennsylvania | 19107 | United States |
| D014947 | Wounds and Injuries |