FES Cycling and Nutritional Counseling for Battling Obesity After SCI

Completed · Not applicable

Conditions studied: Spinal Cord Injuries

In brief

Individuals who suffer from paralysis after spinal cord injury (SCI) are estimated to have an even greater (66%) prevalence of obesity. Obesity is a major public health concern and is associated with a plethora of cardiometabolic health complications (heart disease, stroke and type II diabetes mellitus). Although the benefits of physical activity to counteract obesity and cardiometabolic disease have been documented, SCI typically limits voluntary exercise to the often injured arms (60-90%). On the other hand, functional electrical stimulation (FES) cycling has proven to be a safe and effective way to exercise paralyzed leg muscles in clinical and home settings, saving the often overworked arms. The investigators have developed a novel high-intensity interval training (HIIT) protocol for FES lower extremities cycling that may provide equal or greater benefits with less time commitment. The investigators proof-of-principle study in 3 obese persons with SCI confirmed that HIIT-FES cycling 3 times per week for 8 weeks without dietary monitoring can increase legs lean mass (5-9%), increase cardiovascular health markers (58% on average) and decrease HbA1c blood levels (2-4%). Also, 2 persons decreased body weight and BMI. The investigators hypothesize that combining HIIT-FES cycling with nutritional counseling will be effective for reducing obesity and enhancing cardiometabolic health in persons with chronic SCI. Research AIM: To determine preliminary efficacy of HIIT-FES cycling combined with nutritional counseling in obese adults with SCI. In this pilot two-arm, parallel, pre-post, subject-matched controlled trial, we will test the hypothesis that the experimental group receiving HIIT-FES cycling plus nutritional counseling will decrease total body weight, decrease body fat percentage, decrease fat mass, increase total and legs lean mass, improve blood lipid levels, decrease blood glucose and HbA1c levels and improve vascular endothelial health (flow mediated dilation) significantly more than age-, sex- and injury-matched controls receiving nutritional counseling only. The investigators will recruit 20 obese adults, 21-65 years of age, with chronic post-traumatic SCI ranging in neurological level between C4 and T12. Participants will be divided into experimental (HIIT-FES cycling plus nutritional counseling) and control (nutritional counseling only) groups.

Key facts

Study ID

NCT03810963

Run by

William Carey University

People needed

15

Starts

2017-05-01

Expected to finish

2019-05-01

Last updated by the study team

2019-10-04

Who can join

Age: 21 and older, up to 65. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• We will recruit men and women with C4-T12 SCI (n=20) American Spinal Injury Association Impairment Scale A, B, or C as per International Standards for Neurological Classification of SCI; ≥2 years post-SCI; age 21-65 years; body fat percentage according to over-weight classifications detailed in Gallagher et al. Am J Clin Nut 2000,72:694-701 ( women 20-40 y/o > 30%, 41-60 y/o > 35%, > 60 y/o > 42%; men 20-40 y/o > 19%, 40-60 y/o > 22%, > 60 y/o > 25%).

You may not qualify if…

• Exclusion criteria include pressure wounds on buttocks or feet; unhealed bone fractures or history of fragility fractures; uncontrolled cardiovascular or metabolic disease; severe osteoporosis (T score ≤ 4); uncontrolled autonomic dysreflexia; and current smokers.

Where it is running

• William Carey University Physical Therapy Program — Hattiesburg, Mississippi, United States

Full record on ClinicalTrials.gov

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