Telemonitored Exercise to Attenuate Metabolic Dysregulation in Spinal Cord Injury (TEAM-SCI)

Telemonitored Exercise to Attenuate Metabolic Dysregulation in Spinal Cord Injury (TEAM-SCI)

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

Study Overview

• Status: Recruiting
• Conditions: Spinal Injuries
• Intervention / Treatment: Other: Spinal Cord Injury Exercise Group

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.

• Study Type: Interventional
• Enrollment (Estimated): 20
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Eduard Tiozzo, PhD; Phone Number: 305-243-1633; Email: etiozzo@med.miami.edu

Study Locations

• United States
  • Florida
    • Miami, Florida, United States, 33136
      • Recruiting
      • University of Miami Christine E. Lynn Rehabilitation Center
      • Contact: Dinorah Rodriguez, BSN; Phone Number: 305-243-2797; Email: drodriguez5@med.miami.edu
      • Principal Investigator: Eduard Tiozzo, PhD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Spinal Cord Injury Exercise Group; Participants will exercise at home 3-5 times per week under supervision via teleconference. Participants will be part of this group for 18-20 weeks.	Other: Spinal Cord Injury Exercise Group; Participants will have an initial accommodation period of 4 weeks, during which four 10-minute exercise bouts/day will be interspersed with 5 minutes of rest. The bouts will gradually increase until at least continuous 40-minute sessions. The remaining 12-week intervention will be set at 70% max heart rate for a total of 16 weeks.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in percent body fat	Percent body fat will be assessed using Dual Energy x-ray absorbency (DXA)	Baseline, 20 weeks (Post Intervention)
Change in percent visceral fat	Percent visceral fat will be assessed using DXA	Baseline, 20 weeks (Post Intervention)
Change in percent of lean body mass	Percent lean body mass will be assessed using DXA	Baseline, 20 weeks (Post Intervention)
Change in percent of fat free mass	Percent fat free mass will be assessed using DXA	Baseline, 20 weeks (Post Intervention)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in Lipid Panel values	Lipid panel values including High Density Lipoprotein, Low Density Lipoprotein, Total Cholesterol and triglycerides, all assessed in mg/dL, will be measured from blood samples	Baseline, 20 weeks (Post Intervention)
Change in resting metabolic rate	Change in resting metabolic rate will be measured by using a large clear plastic dome over the head and the air exhaled will be measured	Baseline, 20 weeks (Post Intervention)
Change in glucose levels	Glucose will be measured in mg/dL using blood samples	Baseline, 20 weeks (Post Intervention)
Change in HgbA1C levels	Hemoglobin A1c (HgbA1c) levels will be assessed using blood samples	Baseline, 20 weeks (Post Intervention)
Change in Insulin levels	Insulin levels will be assessed using blood samples	Baseline, 20 weeks (Post Intervention)
Change in hsCRP levels	High sensitivity C Reactive Protein (hsCRP) will be assessed using blood samples	Baseline, 20 weeks (Post Intervention)

Collaborators and Investigators

• Sponsor: University of Miami
• Investigators: Principal Investigator: Eduard Tiozzo, PhD, University of Miami

Study record dates

Study Major Dates

• Study Start (Actual): January 13, 2023
• Primary Completion (Estimated): December 31, 2024
• Study Completion (Estimated): December 31, 2024

Study Registration Dates

• First Submitted: October 24, 2022
• First Submitted That Met QC Criteria: October 24, 2022
• First Posted (Actual): October 27, 2022

Study Record Updates

• Last Update Posted (Actual): January 29, 2024
• Last Update Submitted That Met QC Criteria: January 25, 2024
• Last Verified: January 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Central Nervous System Diseases; Nervous System Diseases; Trauma, Nervous System; Spinal Cord Diseases; Back Injuries; Wounds and Injuries; Spinal Cord Injuries; Spinal Injuries
• Other Study ID Numbers: 20220652

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No