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CompletedNCT05597176TEAM-SCIUpdated Jan 28, 2025

Telemonitored Exercise to Attenuate Metabolic Dysregulation in Spinal Cord Injury

An interventional study of Spinal Cord Injury Exercise Group in Spinal Injuries, sponsored by University of Miami. Completed at 1 site in United States. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2025-01-28.

Sponsored by University of Miami · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
4
Allocation
Not applicable
Ages
18 Years to 65 Years
Sex
All
01

Study summary

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

Read the 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.

02

Conditions studied

  • Spinal Injuries

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03

In context

Spinal Injuries

57 studies on the registry are indexed under Spinal Injuries; 15 are open to participants now.

This study's enrollment of 4 is below the median of 52 across 31 interventional studies indexed under Spinal Injuries.

Browse Spinal Injuries studies →

Lead sponsor

University of Miami is the lead sponsor of 840 studies on the registry; 164 are open to participants now.

Of its 115 completed or terminated interventional studies of FDA-regulated products, 97 (84%) have results posted.

Browse University of Miami studies →

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 65 Years
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Women of 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) after the completion of the dietary intervention in the study.

Exclusion criteria

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
Terms in these criteria, in plain language(2)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Childbearing potential

Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).

Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.

Washout period

A planned gap after a treatment, so that its effects can lessen before the study treatment or a study assessment. Ask the study team and the doctor who prescribed it before changing any medicine.

05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
4 participants (actual)

Study arms

  • 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

Interventions

  • OtherSpinal 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.

06

What researchers measure

Primary outcomes

  1. Change in percent body fat

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

    Time frame: Baseline, 20 weeks (Post Intervention)

  2. Change in percent visceral fat

    Percent visceral fat will be assessed using DXA

    Time frame: Baseline, 20 weeks (Post Intervention)

  3. Change in percent of lean body mass

    Percent lean body mass will be assessed using DXA

    Time frame: Baseline, 20 weeks (Post Intervention)

  4. Change in percent of fat free mass

    Percent fat free mass will be assessed using DXA

    Time frame: Baseline, 20 weeks (Post Intervention)

Secondary outcomes

  1. 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

    Time frame: Baseline, 20 weeks (Post Intervention)

  2. 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

    Time frame: Baseline, 20 weeks (Post Intervention)

  3. Change in glucose levels

    Glucose will be measured in mg/dL using blood samples

    Time frame: Baseline, 20 weeks (Post Intervention)

  4. Change in HgbA1C levels

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

    Time frame: Baseline, 20 weeks (Post Intervention)

  5. Change in Insulin levels

    Insulin levels will be assessed using blood samples

    Time frame: Baseline, 20 weeks (Post Intervention)

  6. Change in hsCRP levels

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

    Time frame: Baseline, 20 weeks (Post Intervention)

07

Study locations

1 site
  • University of Miami Christine E. Lynn Rehabilitation Center
    Miami, Florida 33136, United States
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Ran from Jan 2023 to primary completion in Jan 2025, 24 months.

Of 23 interventional studies with no phase under Spinal Injuries, half reached primary completion within 23 months of starting (the median), counting those still running; a quarter within 8 and three quarters within 75. This study's 24 months is close to that.

How these figures are worked out, and which studies are left out of them.

Registered
Oct 24, 2022
First posted
Oct 27, 2022
StartActual
Jan 13, 2023
Primary completionActual
Jan 24, 2025
CompletionActual
Jan 24, 2025
Last update
Jan 28, 2025
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Jan 28, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT05597176
Lead sponsor
University of Miami
Responsible party
Eduard Tiozzo, PhD (Research Associate Professor, University of Miami) — Principal investigator
First posted
Oct 27, 2022
Start date
Jan 13, 2023
Primary completion
Jan 24, 2025
Completion
Jan 24, 2025
Last update
Jan 28, 2025

Study contacts

Eduard Tiozzo, PhD
principal investigator · University of Miami

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Jan 2025. You cannot join it, but the record below documents what was studied.

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