FES Cycling and Nutritional Counseling for Battling Obesity After SCI

Summary

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.

Conditions

• Spinal Cord Injuries

Interventions

COMBINATION_PRODUCT

HIIT-FES Cycling combined with Nutritional Counseling

High intensity interval training functional electrical stimulation cycling for 30 minutes, three days per week for eight weeks, Nutritional counseling over the telephone for 30 minutes once per week for eight weeks.

OTHER

Nutritional Counseling Only

Nutritional counseling over the telephone for 30 minutes once per week for eight weeks.

Sponsors & Collaborators

• University of Southern Mississippi

  collaborator OTHER

• University of Mississippi Medical Center

  collaborator OTHER

• William Carey University

  lead OTHER

Principal Investigators

• David Dolbow, DPT, PhD · William Carey University

Study Design

Allocation

NON_RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

21 Years

Max Age

65 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2017-05-01

Primary Completion

2019-05-01

Completion

2019-05-01

Countries

• United States

Study Locations