Clinical trial NCT05597176: Telemonitored Exercise to Attenuate Metabolic Dysregulation in Spinal Cord Injury
Official title: Telemonitored Exercise to Attenuate Metabolic Dysregulation in Spinal Cord Injury (TEAM-SCI)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Spinal Injuries
Lead sponsor: University of Miami
Sponsor class: OTHER
First posted: 2022-10-27
Enrollment: 4
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The purpose of this research is to test the health benefits of using functional electrical stimulation for lower extremity exercise at home.

Detailed description: The specific objectives are to assess the impact of 16 weeks of home-based telemonitored functional electrical stimulation leg cycle ergometry (FESLCE) exercise on body composition and metabolic health in adults with C4-T4 motor complete SCI. This study is available only to those who were previously enrolled in the SCIENCE protocol #20190659 that were randomized to the diet alone group. After completing the dietary intervention, those individuals will have an opportunity to experience FES bicycle.

Eligibility criteria: Inclusion Criteria:

* Women of child-bearing potential who agree to refrain from getting pregnant during the trial
* Previously 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 above
* Those who have participated in a Functional Electrical Stimulation (FES) or ACE exercise program (\>60 minutes/week) within the past 3 months
* Self-reported or documented history of:

  * orthopedic limitations
  * coronary artery disease
  * type 1 diabetes mellitus; insulin-requiring Type 2 diabetes mellitus; untreated Type 2 diabetes mellitus
  * untreated hypothyroidism
  * renal disease
  * uncontrolled autonomic dysreflexia, recent (within 3 months)
  * deep vein thrombosis (within the past 3 months)
* On anticoagulation therapy
* Pressure injuries \> Grade II
* Decisional impairment
* Prisoners
* Pregnant or nursing women
* Any potential causes of autonomic dysreflexia at the discretion of the PI

Primary outcomes:
measure: Change in percent body fat
timeFrame: Baseline, 20 weeks (Post Intervention)
measure: Change in percent visceral fat
timeFrame: Baseline, 20 weeks (Post Intervention)
measure: Change in percent of lean body mass
timeFrame: Baseline, 20 weeks (Post Intervention)
measure: Change in percent of fat free mass
timeFrame: Baseline, 20 weeks (Post Intervention)
Secondary outcomes:
measure: Change in Lipid Panel values
timeFrame: Baseline, 20 weeks (Post Intervention)
measure: Change in resting metabolic rate
timeFrame: Baseline, 20 weeks (Post Intervention)
measure: Change in glucose levels
timeFrame: Baseline, 20 weeks (Post Intervention)
measure: Change in HgbA1C levels
timeFrame: Baseline, 20 weeks (Post Intervention)
measure: Change in Insulin levels
timeFrame: Baseline, 20 weeks (Post Intervention)
measure: Change in hsCRP levels
timeFrame: Baseline, 20 weeks (Post Intervention)
Other outcomes:
Locations:
city: Miami
country: United States
facility: University of Miami Christine E. Lynn Rehabilitation Center
state: Florida
Study officials:
affiliation: University of Miami
name: Eduard Tiozzo, PhD
role: PRINCIPAL_INVESTIGATOR
References: