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NCT05597176
Telemonitored Exercise to Attenuate Metabolic Dysregulation in Spinal Cord Injury
Conditions: Spinal Injuries
Sex: All
Ages: 18 Years – 65 Years
Phase: NA
Enrollment: 20
Sponsor: University of Miami
Location: United States
Summary
The purpose of this research is to test the health benefits of using functional electrical stimulation for lower extremity exercise at home.
Eligibility Criteria
Inclusion Criteria:Women of child-bearing potential who agree to refrain from getting pregnant during the trialPreviously enrolled in the SCIENCE protocol (NCT03495986) randomized to the diet alone group in SCIENCE, and are willing to complete an 8-week (2 month) washout period after the completion of the dietary intervention in the study.Exclusion Criteria:Do not meet inclusion criteria aboveThose who have participated in a Functional Electrical Stimulation (FES) or ACE exercise program (>60 minutes/week) within the past 3 monthsSelf-reported or documented history of:orthopedic limitationscoronary artery diseasetype 1 diabetes mellitus; insulin-requiring Type 2 diabetes mellitus; untreated Type 2 diabetes mellitusuntreated hypothyroidismrenal diseaseuncontrolled autonomic dysreflexia, recent (within 3 months)deep vein thrombosis (within the past 3 months)On anticoagulation therapyPressure injuries > Grade IIDecisional impairmentPrisonersPregnant or nursing womenAny potential causes of autonomic dysreflexia at the discretion of the PI
Source: ClinicalTrials.gov (NCT05597176). StuddyBuddy aggregates publicly available trial information.