Telemonitored Exercise to Attenuate Metabolic Dysregulation in Spinal Cord Injury

Spinal Injuries Clinical Trial

— TEAM-SCI  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05597176
• Other study ID #: 20220652
• Status: Recruiting
• Phase: N/A
• Start date: January 13, 2023
• Est. completion date: December 31, 2024

Study information

• Verified date: January 2024
• Source: University of Miami
• Contact: Eduard Tiozzo, PhD
• Phone: 305-243-1633
• Email: etiozzo[@]med.miami.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 20
• Est. completion date: December 31, 2024
• Est. primary completion date: December 31, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Spinal Cord Injuries
• Spinal Injuries
• Wounds and Injuries

Intervention

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.

Locations

Country	Name	City	State
United States	University of Miami Christine E. Lynn Rehabilitation Center	Miami	Florida

Sponsors (1)

Lead Sponsor	Collaborator
University of Miami

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in percent body fat	Percent body fat will be assessed using Dual Energy x-ray absorbency (DXA)	Baseline, 20 weeks (Post Intervention)
Primary	Change in percent visceral fat	Percent visceral fat will be assessed using DXA	Baseline, 20 weeks (Post Intervention)
Primary	Change in percent of lean body mass	Percent lean body mass will be assessed using DXA	Baseline, 20 weeks (Post Intervention)
Primary	Change in percent of fat free mass	Percent fat free mass will be assessed using DXA	Baseline, 20 weeks (Post Intervention)
Secondary	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)
Secondary	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)
Secondary	Change in glucose levels	Glucose will be measured in mg/dL using blood samples	Baseline, 20 weeks (Post Intervention)
Secondary	Change in HgbA1C levels	Hemoglobin A1c (HgbA1c) levels will be assessed using blood samples	Baseline, 20 weeks (Post Intervention)
Secondary	Change in Insulin levels	Insulin levels will be assessed using blood samples	Baseline, 20 weeks (Post Intervention)
Secondary	Change in hsCRP levels	High sensitivity C Reactive Protein (hsCRP) will be assessed using blood samples	Baseline, 20 weeks (Post Intervention)