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Completed

NCT Number: NCT05597176

Telemonitored Exercise to Attenuate Metabolic Dysregulation in Spinal Cord Injury

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

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Key information

Conditions

Spinal Injuries Back Injuries Wounds and Injuries

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Miami Christine E. Lynn Rehabilitation Center

Miami, Florida, 33136, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Spinal Cord Injury Exercise Group

Other

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.

Primary outcomes

  1. Change in percent body fat

    Time frame: Baseline, 20 weeks (Post Intervention)

    Percent body fat will be assessed using Dual Energy x-ray absorbency (DXA)

  2. Change in percent visceral fat

    Time frame: Baseline, 20 weeks (Post Intervention)

    Percent visceral fat will be assessed using DXA

  3. Change in percent of lean body mass

    Time frame: Baseline, 20 weeks (Post Intervention)

    Percent lean body mass will be assessed using DXA

  4. Change in percent of fat free mass

    Time frame: Baseline, 20 weeks (Post Intervention)

    Percent fat free mass will be assessed using DXA

Secondary outcomes

  1. Change in Lipid Panel values

    Time frame: Baseline, 20 weeks (Post Intervention)

    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

  2. Change in resting metabolic rate

    Time frame: Baseline, 20 weeks (Post Intervention)

    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

  3. Change in glucose levels

    Time frame: Baseline, 20 weeks (Post Intervention)

    Glucose will be measured in mg/dL using blood samples

  4. Change in HgbA1C levels

    Time frame: Baseline, 20 weeks (Post Intervention)

    Hemoglobin A1c (HgbA1c) levels will be assessed using blood samples

  5. Change in Insulin levels

    Time frame: Baseline, 20 weeks (Post Intervention)

    Insulin levels will be assessed using blood samples

  6. Change in hsCRP levels

    Time frame: Baseline, 20 weeks (Post Intervention)

    High sensitivity C Reactive Protein (hsCRP) will be assessed using blood samples

Sponsors and collaborators

Lead sponsor

University of Miami

Other

Registry information

Official study title

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

Acronym: TEAM-SCI

Important dates

Study start
2023
Primary completion
2025
Study completion
2025
First posted
Oct 27, 2022
Registry last updated
Jan 28, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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