Spinal Cord InjuriesSCIENCENCT03495986
Spinal Cord Injury Exercise and Nutrition Conceptual Engagement
A study testing Functional Electrical Stimulation Leg Cycle Ergometry and Diet in people with Spinal Cord Injuries and Metabolic Syndrome, run by University of Miami at 1 site in United States.
Trial summary
Evaluate and compare the health benefits of an at home exercise program using functional electrical stimulation (FES) for lower extremity exercise with diet versus a diet alone group in adults with spinal cord injury. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Spinal Cord Injuries, Metabolic Syndrome, Dietary Modification
- What is being tested?
- Functional Electrical Stimulation Leg Cycle Ergometry and Diet
- Type of treatment
- Medical device, Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 26 participants
- Where
- 1 siteUnited States
- Study dates
- 10 Jun 2021to 24 Jul 2024
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
- Adults 18-65 years of age (inclusive)
- Sex: male or female
- Women of child-bearing potential who agree to refrain from getting pregnant during the trial
- C4-T4 motor complete (AIS A\&B) spinal cord injury for duration greater than 12 months
- <5% change in body weight over the past 12 months
Who cannot join
- <22% body fat
- Unresponsive to neurostimulation
- Those who have participated in an FES or ACE exercise program (>60 minutes/week) within the past 3 months
- Known orthopaedic limitations
- Coronary artery disease
- Type 1 diabetes mellitus, insulin-requiring Type 2 or untreated diabetes mellitus (fasting glucose>126 or HgbA1c>7.0)
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- Uncompensated Hypothyroidism (Stable on medication >1 year or not on medication)
- Renal disease
- Uncontrolled autonomic dysreflexia, recent (within 3 months)
- Deep vein thrombosis
- Pressure ulcers > Grade II
- Decisional impairment
- Any potential causes of autonomic dysreflexia at the discretion of the PI
- Prisoners
- Pregnant or nursing women
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Spinal Cord Injury Exercise and Nutrition Conceptual Engagement (SCIENCE)
Evaluate and compare the health benefits of an at home exercise program using functional electrical stimulation (FES) for lower extremity exercise with diet versus a diet alone group in adults with spinal cord injury.
Read the detailed description
The purpose of this proposal is to evaluate and compare the health benefits of home-based functional electrical stimulation leg cycle ergometry plus diet (HBFESLCE + Diet) to home-based (HB) Diet alone. This is a randomized, baseline-controlled, prospective, interventional trial to assess the impact of a 16-week exercise and/or diet intervention on selected fitness parameters in adults with high SCI. Primary outcome measures will include body composition by iDXA, insulin sensitivity, glucose effectiveness and BMR, while secondary outcomes will include lower extremity BMC and density, lipid profiles, and hsCRP determined before and after the 16-week interventions. Subjects will be randomly assigned to either HBFES LCE + Diet on an RT300 ergometer or Home-based (HB) Diet Alone intervention. Both groups will be routinely monitored via telemedicine while at home.
- Being tested
- Functional Electrical Stimulation Leg Cycle Ergometry, Diet
- Keywords
- Functional Electrical Stimulation, Exercise, Body Composition
- Medical subject headings
- Spinal Cord Injuries, Metabolic Syndrome, Paraplegia, Quadriplegia, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Functional Electrical Stimulation Leg Cycle ErgometryDevice
Exercise training will consist of three to five, 40-67 minute sessions (200 minutes at target intensity) each week for a total of 16 weeks at 70% maximal heart rate; 10-minute warm-up and cool-down sessions will accompany each exercise session.
DietBehavioural
An individualized, detailed dietary plan consistent with My Healthy Plate Dietary Guidelines of America will be followed under supervision of Registered Dietitian with weekly telemedicine conferences and monitored dietary intake via MyFitnessPal.
| Study group | Role | What they receive |
|---|---|---|
| Home-Based Exercise & Diet Group | Experimental | 16-week home based functional electrical stimulation leg cycle ergometry exercise program and diet intervention Receives: Device: Functional Electrical Stimulation Leg Cycle Ergometry; Behavioral: Diet |
| Home-Based Diet Alone Group | Placebo comparator | Diet intervention Receives: Behavioral: Diet |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percent Body Fat Assessed by DXA at Baseline and 21 Weeks
Percent body fat will be assessed in percentage using Dual Energy x-ray absorbency (DXA). Assessments will be conducted at baseline and at 21 weeks to evaluate changes in body composition over time.
Measured: Baseline, 21 weeks
Fat Free Mass
Body composition will be assessed using Dual-Energy X-ray Absorptiometry (DXA), which provides precise measurements of both absolute fat mass (FM) and absolute fat-free mass (FFM) in kilograms. FFM represents a distinct component of total body mass and will be used to evaluate lean tissue (i.e.,FFM) over time.
Measured: Baseline, 21 weeks
Change in Insulin Sensitivity (Si)
Insulin Sensitivity will be measured using intravenous glucose tolerance test (IVGTT)
Measured: Baseline, 21 weeks
Change in Glucose Effectiveness (Sg)
Glucose Effectiveness will be measured using IVGTT
Measured: Baseline, 21 weeks
Change in Basal Metabolic Rate (BMR)
BMR will be measured by indirect calorimetry
Measured: Baseline, 21 weeks
Secondary outcomes (4)
High Density Lipoprotein Cholesterol (HDL-C)
HDL-C will be measured from blood serum samples
Measured: Baseline, 21 weeks
Change in Total Cholesterol : HDL-C Ratio
Total Cholesterol HDL-C ratio will be calculated from blood serum samples reported as a numeric value, representing the ratio of Total Cholesterol to HDL-C.
Measured: Baseline, 21 weeks
C-Reactive Protein (hsCRP)
hsCRP will be measured from blood serum samples
Measured: Baseline, 21 weeks
Lower Extremity Bone Mineral Density (BMD) - Femur
The changes in Bone Mineral Density will be measured using DXA scan
Measured: Baseline, 21 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Apr 2018
- Study start10 Jun 2021
- Primary completion24 Jul 2024
- Study completion24 Jul 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Spinal Cord 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 26 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Miami
- Sponsor type
- University, hospital or other
- Collaborators
- Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
- Responsible party
- Principal investigator, Eduard Tiozzo, PhD, University of Miami
- Investigators
- Eduard Tiozzo, PhD, MSCTI, Principal investigator, University of Miami
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03495986
- Sponsor's protocol ID
- 20190659
- Other IDs
- R01HD091278-01, 6996
- Acronym
- SCIENCE
- Status last verified
- Dec 2025
- First submitted
- 2 Mar 2018
- Last updated
- 22 Dec 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Spinal Cord Injury Exercise and Nutrition Conceptual Engagement (SCIENCE)
- ClinicalTrials.gov ID
- NCT03495986
- Acronym / sponsor ID
- SCIENCE / 20190659
- Keywords
- Functional Electrical Stimulation, Exercise, Body Composition
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 26 participants (actual)
- Lead sponsor
- University of MiamiUniversity, hospital or other
- Collaborators
- Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
- Study start
- 10 Jun 2021 (actual)
- Primary completion
- 24 Jul 2024 (actual)
- Study completion
- 24 Jul 2024 (actual)
- First posted
- 12 Apr 2018 (actual)
- Results
- Posted 22 Dec 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Evaluate and compare the health benefits of an at home exercise program using functional electrical stimulation (FES) for lower extremity exercise with diet versus a diet alone group in adults with spinal cord injury.
Detailed description
The purpose of this proposal is to evaluate and compare the health benefits of home-based functional electrical stimulation leg cycle ergometry plus diet (HBFESLCE + Diet) to home-based (HB) Diet alone. This is a randomized, baseline-controlled, prospective, interventional trial to assess the impact of a 16-week exercise and/or diet intervention on selected fitness parameters in adults with high SCI. Primary outcome measures will include body composition by iDXA, insulin sensitivity, glucose effectiveness and BMR, while secondary outcomes will include lower extremity BMC and density, lipid profiles, and hsCRP determined before and after the 16-week interventions. Subjects will be randomly assigned to either HBFES LCE + Diet on an RT300 ergometer or Home-based (HB) Diet Alone intervention. Both groups will be routinely monitored via telemedicine while at home.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Home-Based Exercise & Diet Group | Experimental | Device: Functional Electrical Stimulation Leg Cycle Ergometry, Behavioral: Diet16-week home based functional electrical stimulation leg cycle ergometry exercise program and diet intervention |
| Home-Based Diet Alone Group | Placebo comparator | Behavioral: DietDiet intervention |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Adults 18-65 years of age (inclusive)
- Sex: male or female
- Women of child-bearing potential who agree to refrain from getting pregnant during the trial
- C4-T4 motor complete (AIS A\&B) spinal cord injury for duration greater than 12 months
- <5% change in body weight over the past 12 months
Key exclusion criteria (15 listed)
- <22% body fat
- Unresponsive to neurostimulation
- Those who have participated in an FES or ACE exercise program (>60 minutes/week) within the past 3 months
- Known orthopaedic limitations
- Coronary artery disease
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 |
|---|---|---|
| Functional Electrical Stimulation Leg Cycle ErgometryExercise training will consist of three to five, 40-67 minute sessions (200 minutes at target intensity) each week for a total of 16 weeks at 70% maximal heart rate; 10-minute warm-up and cool-down sessions will accompany each exercise session. | Device | Home-Based Exercise & Diet Group |
| DietAn individualized, detailed dietary plan consistent with My Healthy Plate Dietary Guidelines of America will be followed under supervision of Registered Dietitian with weekly telemedicine conferences and monitored dietary intake via MyFitnessPal. | Behavioural | Home-Based Diet Alone Group, Home-Based Exercise & Diet Group |
Primary outcome
Percent Body Fat Assessed by DXA at Baseline and 21 Weeks
Time frame: Baseline, 21 weeks
Percent body fat will be assessed in percentage using Dual Energy x-ray absorbency (DXA). Assessments will be conducted at baseline and at 21 weeks to evaluate changes in body composition over time.
Fat Free Mass
Time frame: Baseline, 21 weeks
Body composition will be assessed using Dual-Energy X-ray Absorptiometry (DXA), which provides precise measurements of both absolute fat mass (FM) and absolute fat-free mass (FFM) in kilograms. FFM represents a distinct component of total body mass and will be used to evaluate lean tissue (i.e.,FFM) over time.
Change in Insulin Sensitivity (Si)
Time frame: Baseline, 21 weeks
Insulin Sensitivity will be measured using intravenous glucose tolerance test (IVGTT)
Change in Glucose Effectiveness (Sg)
Time frame: Baseline, 21 weeks
Glucose Effectiveness will be measured using IVGTT
Change in Basal Metabolic Rate (BMR)
Time frame: Baseline, 21 weeks
BMR will be measured by indirect calorimetry
4 secondary outcomes
High Density Lipoprotein Cholesterol (HDL-C)
Time frame: Baseline, 21 weeks
Change in Total Cholesterol : HDL-C Ratio
Time frame: Baseline, 21 weeks
C-Reactive Protein (hsCRP)
Time frame: Baseline, 21 weeks
Lower Extremity Bone Mineral Density (BMD) - Femur
Time frame: Baseline, 21 weeks
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Dec 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- 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, MSCTI 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 Functional Electrical Stimulation Leg Cycle Ergometry and Diet in people with Spinal Cord Injuries and Metabolic Syndrome, 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 5 inclusion and 15 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 22 Dec 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. Some participants in this study may receive a placebo. 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?
Yes. Results are posted in the registry (first posted 22 Dec 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Percent Body Fat Assessed by DXA at Baseline and 21 Weeks (time frame: Baseline, 21 weeks). The study lists 5 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 22 Dec 2025.