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A randomized controlled trial on the effects of cycling with and without electrical stimulation on cardiorespiratory and vascular health in children with spinal cord injury
Johnston TE, Smith BT, Mulcahey MJ, Betz RR, Lauer RT
Archives of Physical Medicine and Rehabilitation 2009 Aug;90(8):1379-1388
clinical trial
5/10 [Eligibility criteria: Yes; Random allocation: Yes; Concealed allocation: No; Baseline comparability: No; Blind subjects: No; Blind therapists: No; Blind assessors: Yes; Adequate follow-up: Yes; Intention-to-treat analysis: No; Between-group comparisons: Yes; Point estimates and variability: Yes. Note: Eligibility criteria item does not contribute to total score] *This score has been confirmed*

OBJECTIVE: To examine the cardiorespiratory/vascular effects of cycling with and without functional electrical stimulation (FES) in children with spinal cord injury (SCI). DESIGN: Randomized controlled trial. SETTING: Pediatric referral hospital. PARTICIPANTS: Children with SCI (N = 30), ages 5 to 13 years, with injury levels from C4 to T11, and American Spinal Injury Association grades A, B, or C. INTERVENTIONS: Children were randomly assigned to 1 of 3 groups: FES leg cycling exercise, passive leg cycling, or noncycling control group receiving electrical stimulation therapy. After receiving instruction on the use of the equipment, children exercised for 1 hour 3 times per week for 6 months at home with parental supervision. MAIN OUTCOME MEASURES: Oxygen uptake (VO2) during an incremental arm ergometry test, resting heart rate, forced vital capacity, and a fasting lipid profile. RESULTS: There were no differences (p > 0.05) between groups after 6 months of exercise when comparing pre- and postvalues. However, there were differences between groups for some variables when examining percent change. The FES cycling group showed an improvement (p = 0.035) in VO2 (16.2% +/- 25.0%) as compared with the passive cycling group (-28.7% +/- 29.1%). For lipid levels, the electrical stimulation-only group showed declines (p = 0.032) in cholesterol levels (-17.1% +/- 8.5%) as compared with the FES cycling group (4.4% +/- 20.4%). CONCLUSIONS: Cycling with FES led to gains in VO2, whereas electrical stimulation alone led to improvements in cholesterol.

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