The Effects of Two Functional Electrical Stimulation Cycling Paradigms
Condition: Spinal Cord Injury
MeSH terms: Spinal Cord Injuries
Study type: Interventional
Phase: Phase 2/Phase 3

Summary: 
      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.
    


Intervention name(s): Cycling with functional electrical stimulation
Intervention type(s): Other
Intervention description(s): 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).
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Spinal Cord Injury; Cycling; Functional Electrical Stimulation