Spinal Cord Injury Exercise and Nutrition Conceptual Engagement (SCIENCE)

Status: Recruiting
Location: See location...
Intervention Type: Device, Behavioral
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY

Evaluate and compare the health benefits of an at home exercise program using functional electrical stimulation (FES) for lower extremity exercise with diet versus a diet alone group in adults with spinal cord injury.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 65
Healthy Volunteers: No
View:

• Adults 18-65 years of age (inclusive)

• Sex: male or female

• Women of child-bearing potential who agree to refrain from getting pregnant during the trial

• C4-T4 motor complete (AIS A&B) spinal cord injury for duration greater than 12 months

• <5% change in body weight over the past 12 months

Locations
United States
Florida
University of Miami
Recruiting
Miami
Contact Information
Primary
David Gater, D, PhD, MS
dgater@miami.edu
305-243-9516
Time Frame
Start Date: June 10, 2021
Estimated Completion Date: May 31, 2023
Participants
Target number of participants: 60
Treatments
Experimental: Home-Based Exercise & Diet Group
16-week home based functional electrical stimulation leg cycle ergometry exercise program and diet intervention
Placebo Comparator: Home-Based Diet Alone Group
Diet intervention
Sponsors
Collaborators: Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Leads: University of Miami

This content was sourced from clinicaltrials.gov

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