Hybrid-FES Exercise to Prevent Cardiovascular Declines in Acute SCI

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

• 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.

• 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.

• 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

Inclusion criteria

• Spinal cord injured outpatients aged 18-40
• medically stable
• body mass index 18.5-30.0
• 3-12 months post SCI
• ASIA scale A, B or C at neurological level C5-T12
• able to follow directions
• leg muscles responsive to FES

Exclusion criteria

• hypertension
• significant arrhythmias
• coronary artery disease
• diabetes
• renal disease
• cancer
• epilepsy
• current use of cardioactive medications
• current grade 2 or greater pressure ulcers at relevant contact sites
• other neurological disease
• peripheral nerve compressions or rotator cuff tears that limit ability to row
• history of bleeding disorder