Spinal InjuriesTEAM-SCINCT05597176
Telemonitored Exercise to Attenuate Metabolic Dysregulation in Spinal Cord Injury
A study testing Spinal Cord Injury Exercise Group in people with Spinal Injuries, run by University of Miami at 1 site in United States.
Trial summary
The purpose of this research is to test the health benefits of using functional electrical stimulation for lower extremity exercise at home. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Spinal Injuries
- What is being tested?
- Spinal Cord Injury Exercise Group
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 4 participants
- Where
- 1 siteUnited States
- Study dates
- 13 Jan 2023to 24 Jan 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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
Show all 16Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Miami Christine E. Lynn Rehabilitation Center
Miami, Florida, 33136
About this study
Official title: 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.
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.
- Conditions
- Spinal Injuries
- Being tested
- Spinal Cord Injury Exercise Group
- Medical subject headings
- Spinal Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Spinal Cord Injury Exercise GroupOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Spinal Cord Injury Exercise Group | Experimental | 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. Receives: Other: Spinal Cord Injury Exercise Group |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in percent body fat
Percent body fat will be assessed using Dual Energy x-ray absorbency (DXA)
Measured: Baseline, 20 weeks (Post Intervention)
Change in percent visceral fat
Percent visceral fat will be assessed using DXA
Measured: Baseline, 20 weeks (Post Intervention)
Change in percent of lean body mass
Percent lean body mass will be assessed using DXA
Measured: Baseline, 20 weeks (Post Intervention)
Change in percent of fat free mass
Percent fat free mass will be assessed using DXA
Measured: Baseline, 20 weeks (Post Intervention)
Secondary outcomes (6)
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
Measured: 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
Measured: Baseline, 20 weeks (Post Intervention)
Change in glucose levels
Glucose will be measured in mg/dL using blood samples
Measured: Baseline, 20 weeks (Post Intervention)
Change in HgbA1C levels
Hemoglobin A1c (HgbA1c) levels will be assessed using blood samples
Measured: Baseline, 20 weeks (Post Intervention)
Change in Insulin levels
Insulin levels will be assessed using blood samples
Measured: Baseline, 20 weeks (Post Intervention)
Change in hsCRP levels
High sensitivity C Reactive Protein (hsCRP) will be assessed using blood samples
Measured: Baseline, 20 weeks (Post Intervention)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Oct 2022
- Study start13 Jan 2023
- Primary completion24 Jan 2025
- Study completion24 Jan 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Spinal InjuriesStudies of the same condition, open and under way.
- More trials run by University of MiamiThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 4 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Miami
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Eduard Tiozzo, PhD, University of Miami
- Investigators
- Eduard Tiozzo, PhD, Principal investigator, University of Miami
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05597176
- Sponsor's protocol ID
- 20220652
- Acronym
- TEAM-SCI
- Status last verified
- Jan 2025
- First submitted
- 24 Oct 2022
- Last updated
- 28 Jan 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Telemonitored Exercise to Attenuate Metabolic Dysregulation in Spinal Cord Injury (TEAM-SCI)
- ClinicalTrials.gov ID
- NCT05597176
- Acronym / sponsor ID
- TEAM-SCI / 20220652
- Conditions
- Spinal Injuries
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 4 participants (actual)
- Lead sponsor
- University of MiamiUniversity, hospital or other
- Study start
- 13 Jan 2023 (actual)
- Primary completion
- 24 Jan 2025 (actual)
- Study completion
- 24 Jan 2025 (actual)
- First posted
- 27 Oct 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Spinal Cord Injury Exercise Group | Experimental | Other: Spinal Cord Injury Exercise GroupParticipants will exercise at home 3-5 times per week under supervision via teleconference. Participants will be part of this group for 18-20 weeks. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 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.
Key exclusion criteria (16 listed)
- 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:
- On anticoagulation therapy
- Pressure injuries > Grade II
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Spinal Cord Injury Exercise GroupParticipants 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. | Other | Spinal Cord Injury Exercise Group |
Primary outcome
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)
Change in percent visceral fat
Time frame: Baseline, 20 weeks (Post Intervention)
Percent visceral fat will be assessed using DXA
Change in percent of lean body mass
Time frame: Baseline, 20 weeks (Post Intervention)
Percent lean body mass will be assessed using DXA
Change in percent of fat free mass
Time frame: Baseline, 20 weeks (Post Intervention)
Percent fat free mass will be assessed using DXA
6 secondary outcomes
Change in Lipid Panel values
Time frame: Baseline, 20 weeks (Post Intervention)
Change in resting metabolic rate
Time frame: Baseline, 20 weeks (Post Intervention)
Change in glucose levels
Time frame: Baseline, 20 weeks (Post Intervention)
Change in HgbA1C levels
Time frame: Baseline, 20 weeks (Post Intervention)
Change in Insulin levels
Time frame: Baseline, 20 weeks (Post Intervention)
Change in hsCRP levels
Time frame: Baseline, 20 weeks (Post Intervention)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Jan 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Eduard Tiozzo, PhD principal investigator
University of Miami
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Spinal Cord Injury Exercise Group in people with Spinal Injuries, run by University of Miami at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 28 Jan 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in percent body fat (time frame: Baseline, 20 weeks (Post Intervention)). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Jan 2025.