Hybrid-FES Exercise to Prevent Cardiovascular Declines in Acute SCI
Condition: Spinal Cord Injury
MeSH terms: Spinal Cord Injuries
Study type: Interventional

Summary: 
      Each year, 11,000 people suffer a spinal cord injury (SCI) in the U.S. Within the first year,
      there are profound declines in physiologic function, forming the underlying substrate for
      future cardiovascular disease . In fact, acquired cardiovascular disease is an increasingly
      recognized consequence of SCI and is the leading cause of death in SCI. Though incompletely
      understood, the almost 10-fold prevalence of cardiovascular disease results in part from
      profound physiologic 'detraining' resulting from motor impairment and immobility. Currently,
      effective interventions preventing acute declines that lead to cardiovascular compromise and
      increased risk in SCI are lacking - exercise therapy for those with SCI is challenging and
      when employed, is typically limited to the upper body. Recently, the investigators refined a
      unique form of exercise for those with SCI that specifically mirrors exercise performed by
      those without SCI. Functional Electrical Stimulation (FES) Row Training (RT) couples
      volitional arm and electrically controlled leg exercise, resulting in a hemodynamic profile
      that produces the beneficial cardiac loading conditions of large muscle mass exercise. As
      such, FES-RT may be a safe and effective way to attenuate cardiovascular declines following
      SCI. The investigators aims are to test the overall hypotheses that FES-RT will: 1) mitigate
      against increased visceral adiposity and reduced insulin sensitivity, 2) prevent worsening
      lipid profile and compromised baroreflex function, and 3) counter ventricular wall thickening
      and declining ventricular function occurring with acute SCI, and that these effects will be
      greater than that observed with an arms-only exercise group. Changes with FES-RT will be
      compared to a time (wait-list) control and to arms-only-RT. Individuals with an SCI within
      the last 3-6 months will be randomized to FES-RT, to a time control, or arms-only-RT.
      Measures will be made at baseline and 6 months. The investigators work will provide results
      that clearly delineate potential health benefits of FES-RT, and if FES-RT is effective in a
      majority of those with SCI, its application, implementation, and integration could be easily
      replicated.
    

Detailed description: 
      We will enroll approximately 60 individuals within three to six months post SCI to obtain
      data on 50 individuals. One-half of the subjects (N=25) will be randomized to immediately
      enroll in 6 months of FES-RT. One third (N=18) will be randomized to a wait-list to provide
      time control data from baseline to 6 months. A wait-list control group is routine in exercise
      studies because most volunteers are interested in participating in an exercise program.
      Hence, time controls are difficult to capture since many of those randomized to receive no
      exercise either drop from the study entirely, or end up pursuing some form of exercise on
      their own. Therefore, a vehicle for enrollment of a time control group that is acceptable to
      most volunteers is a wait-list. Therefore, a six month time control will provide data on
      expected declines and then subjects will be randomized to six months exercise.

      Training Protocols for Each Study Group

        1. FES-RT GROUP

           Subjects will begin with short intervals of FES-RT interspersed with rest intervals
           and/or arms-only rowing intervals depending on fitness level and the response to the
           FES. A maximum FES-rowing test will be performed at baseline. This will be repeated
           after three months of training and training intensity will be adjusted to maintain the
           training stimulus at the same relative intensity. The goal is for each volunteer to
           achieve an exercise intensity of 75-85% maintained for a continuous 30 minutes performed
           three times each week. A maximum FES-rowing test will be performed at the end of the six
           months of FES-RT to determine increases in fitness.

        2. ARMS-ONLY-RT GROUP

           Training sessions will be 3 times per week for 26 weeks. To parallel the FES-RT, the
           initial training sessions will also consist of 6 sets of arms-only rowing for five
           minutes at 60% of VO2peak with a work-to-rest ratio of 2:1 and progress over the six
           months to an exercise intensity of 75-85% maintained for 30 minutes performed three
           times each week. A maximum arms-only rowing test will be performed at baseline. This
           will be repeated after three months of training and training intensity will be adjusted
           to maintain the training stimulus at the same relative intensity. A maximum arms-only
           rowing test will be performed at the end of the six months of training to determine
           increases in fitness.

        3. WAIT-LIST GROUP

      The wait list group will not participate in any training for 6 months. A maximum arms-only
      rowing test will be performed immediately after enrollment, after initial familiarization
      with arms-only-RT equipment (usually 2-3 sessions) and will be repeated after 3 and 6 months
    

Intervention name(s): FES-row-training; Arms-only-row training; Time Control
Intervention type(s): Other; Other; Other
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Three intervention groups (Control, AO-Row, and FES-RT) run in parallel
Masking: None (Open Label)
Primary purpose: Prevention