An interventional study of Functional Electrical Stimulation Leg Cycle Ergometry and Diet in Spinal Cord Injuries, Metabolic Syndrome and Dietary Modification, 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 2025-12-22.
Sponsored by University of Miami · Not applicable, Interventional, and Treatment
Among 45 studies in Spinal Cord Injuries by University of Miami — 12 open to participants now, 14 under way, 1 of them phase 3. Spinal Cord Injuries · University of Miami.
Among the 45 studies in Spinal Cord Injuries by University of Miami, this one is the 19th largest by enrollment of the 37 interventional ones that give a count, is one of 2 that started in 2021, is one of 33 with no phase, and was the 22nd registered.
2,025 studies on the registry are indexed under Spinal Cord Injuries; 537 are open to participants now.
Browse Spinal Cord Injuries studies →12 of the 45 studies in Spinal Cord Injuries by University of Miami are open now, in 1 country. Recruiting first, the newest first:
University of Miami · Sites in United States
Ages 22–70
University of Miami · Sites in United States
Ages 18–70 · Healthy volunteers
University of Miami · Sites in United States
Ages 18–70 · Healthy volunteers
University of Miami · Sites in United States
Ages 18–70 · Healthy volunteers
University of Miami · Sites in United States
Ages 18–70
By country, each count listing its studies:
Of the 375 Spinal Cord Injuries studies recruiting now, 166 (44%) set no upper age limit and 158 (42%) stop at 75 or younger; 41 take children under 18; 52 take healthy volunteers.
This study: 18 Years to 65 Years · all sexes · no healthy volunteers.
The full table on the hub →This tab as a report to print or save as PDF → With an account.
45 studies; the count open now beside each. This study's row is marked.
A study in two phases is counted once above. Listed by phase, each with its combined phases: Phase 1 1 · Phase 2 3 · Phase 3 2
First in 1991; this study’s year is marked. 2 started in 2021.
By drug class, each counting the studies that test any of its medicines:
This study's enrollment of 26 is close to the median of 24 across 1,633 interventional studies indexed under Spinal Cord Injuries.
Median enrollment 26 across the 37 interventional studies, 53 across the 8 observational. Of the 29 that completed or were terminated, 7 (24%) have results posted.
This tab as a report to print or save as PDF → With an account.
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.
8 of the studies in Spinal Cord Injuries by University of Miami that are under way reach primary completion within a year, 1 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT05903859Phase 3University of MiamiImprovement of Reproductive Function in Men With Spinal Cord Injury (SCI) | 2027-05-31 |
| NCT06494059University of MiamiA Novel Repetitive Synchronized Associative Stimulation Neuromodulation Approach for Spinal Cord Injury Patients | 2026-12-30 |
| NCT06406855University of MiamiBrain-Controlled Spinal Stimulation Walking Therapy After Incomplete Spinal Cord Injury (SCI) | 2026-12-31 |
| NCT06003686University of MiamiSpinal Cord Injury Model Systems (SCIMS) - Education Module | 2026-12-31 |
| NCT07052344University of MiamiGut-Brain Neural Coupling in Spinal Cord Injury | 2026-12-31 |
Among the 45 studies in Spinal Cord Injuries by University of Miami, from their registry updates:
This tab as a report to print or save as PDF → With an account.
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.
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.
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.
Exclusion criteria:
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.
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.
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.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
16-week home based functional electrical stimulation leg cycle ergometry exercise program and diet intervention
Device: Functional Electrical Stimulation Leg Cycle Ergometry · Behavioral: Diet
Diet intervention
Behavioral: Diet
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.
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.
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.
Time frame: 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.
Time frame: Baseline, 21 weeks
Change in Insulin Sensitivity (Si)
Insulin Sensitivity will be measured using intravenous glucose tolerance test (IVGTT)
Time frame: Baseline, 21 weeks
Change in Glucose Effectiveness (Sg)
Glucose Effectiveness will be measured using IVGTT
Time frame: Baseline, 21 weeks
Change in Basal Metabolic Rate (BMR)
BMR will be measured by indirect calorimetry
Time frame: Baseline, 21 weeks
High Density Lipoprotein Cholesterol (HDL-C)
HDL-C will be measured from blood serum samples
Time frame: 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.
Time frame: Baseline, 21 weeks
C-Reactive Protein (hsCRP)
hsCRP will be measured from blood serum samples
Time frame: Baseline, 21 weeks
Lower Extremity Bone Mineral Density (BMD) - Femur
The changes in Bone Mineral Density will be measured using DXA scan
Time frame: Baseline, 21 weeks
| Milestone | Home-Based Exercise & Diet Group | Home-Based Diet Alone Group |
|---|---|---|
| Started | 13 | 13 |
| Completed | 10 | 12 |
| Not completed | 3 | 1 |
| Withdrew: Physician decision | 1 | 0 |
| Withdrew: Withdrawal by subject | 1 | 1 |
| Withdrew: Withdrawal by subject | 1 | 0 |
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.
| % of body fat | Exercise and Diet | Diet Only |
|---|---|---|
| Baseline | 26.6 ± 9.0 | 25.9 ± 9.6 |
| 21 weeks | 22.0 ± 5.3 | 25.6 ± 6.9 |
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.
| kilograms | Home-Based Exercise & Diet Group | Home-Based Diet Alone Group |
|---|---|---|
| Baseline | 48.7 ± 8.3 | 48.1 ± 6.8 |
| 21 weeks | 48.5 ± 7.1 | 49.4 ± 7.7 |
Insulin Sensitivity will be measured using intravenous glucose tolerance test (IVGTT)
| min^-1/microU/mL^-1) _x10^-4 | Home-Based Exercise & Diet Group | Home-Based Diet Alone Group |
|---|---|---|
| Baseline | 4.1 ± 9.9 | 3.2 ± 4.3 |
| 21 weeks | 1.8 ± 1.5 | 1.5 ± 1.4 |
Glucose Effectiveness will be measured using IVGTT
| glucose clearance per minute (min-¹) | Home-Based Exercise & Diet Group | Home-Based Diet Alone Group |
|---|---|---|
| Baseline | 0.027 ± 0.016 | 0.019 ± 0.018 |
| 21 weeks | 0.027 ± 0.008 | 0.015 ± 0.006 |
BMR will be measured by indirect calorimetry
| kcal/day | Home-Based Exercise & Diet Group | Home-Based Diet Alone Group |
|---|---|---|
| Baseline | 1587.4 ± 249.5 | 1502.5 ± 234.6 |
| 21 weeks | 1588.8 ± 139.8 | 1510.0 ± 178.4 |
HDL-C will be measured from blood serum samples
| mg/dl | Home-Based Exercise & Diet Group | Home-Based Diet Alone Group |
|---|---|---|
| Baseline | 40.4 ± 8.0 | 41.5 ± 12.4 |
| 21 weeks | 41.8 ± 7.4 | 39.7 ± 10.3 |
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.
| ratio | Exercise and Diet | Diet Only |
|---|---|---|
| Baseline | 4.66 ± 1.66 | 3.81 ± 1.30 |
| 21 weeks | 4.53 ± 1.46 | 3.95 ± 1.22 |
hsCRP will be measured from blood serum samples
| mg/L | Exercise and Diet | Diet Only |
|---|---|---|
| Baseline | 8.8 ± 12.4 | 8.8 ± 10.2 |
| 21 weeks | 2.6 ± 1.3 | 5.2 ± 4.0 |
The changes in Bone Mineral Density will be measured using DXA scan
| g/cm³ | Home-Based Exercise & Diet Group | Home-Based Diet Alone Group |
|---|---|---|
| Baseline | 0.8 ± 0.1 | 0.7 ± 0.2 |
| 21 weeks | 0.8 ± 0.2 | 0.7 ± 0.2 |
Collected over 6 months. Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Home-Based Exercise & Diet Group | 0/13 (0%) | 5/13 (38.5%) | 7/13 (53.8%) |
| Home-Based Diet Alone Group | 0/13 (0%) | 2/13 (15.4%) | 1/13 (7.7%) |
| Event | Home-Based Exercise & Diet Group | Home-Based Diet Alone Group |
|---|---|---|
| Heart failureRespiratory, thoracic and mediastinal disorders | 1/13 | 0/13 |
| Urinary tract infection (UTI)Infections and infestations | 1/13 | 1/13 |
| Heterotopic ossificationMusculoskeletal and connective tissue disorders | 1/13 | 0/13 |
| Pulmonary embolismCardiac disorders | 1/13 | 0/13 |
| HyponatremiaMetabolism and nutrition disorders | 1/13 | 0/13 |
| Autonomic DysreflexiaNervous system disorders | 0/13 | 1/13 |
| Event | Home-Based Exercise & Diet Group | Home-Based Diet Alone Group |
|---|---|---|
| Skin IrritationSkin and subcutaneous tissue disorders | 7/13 | 1/13 |
| Age, Categorical(Participants) | Home-Based Exercise & Diet Group | Home-Based Diet Alone Group | Total |
|---|---|---|---|
| <=18 years | 0 | 0 | 0 |
| Between 18 and 65 years | 13 | 13 | 26 |
| >=65 years | 0 | 0 | 0 |
| Sex: Female, Male(Participants) | Home-Based Exercise & Diet Group | Home-Based Diet Alone Group | Total |
|---|---|---|---|
| Female | 2 | 1 | 3 |
| Male | 11 | 12 | 23 |
| Ethnicity (NIH/OMB)(Participants) | Home-Based Exercise & Diet Group | Home-Based Diet Alone Group | Total |
|---|---|---|---|
| Hispanic or Latino | 7 | 7 | 14 |
| Not Hispanic or Latino | 5 | 6 | 11 |
| Unknown or Not Reported | 1 | 0 | 1 |
| Race (NIH/OMB)(Participants) | Home-Based Exercise & Diet Group | Home-Based Diet Alone Group | Total |
|---|---|---|---|
| American Indian or Alaska Native | 0 | 0 | 0 |
| Asian | 0 | 0 | 0 |
| Native Hawaiian or Other Pacific Islander | 0 | 0 | 0 |
| Black or African American | 4 | 3 | 7 |
| White | 9 | 9 | 18 |
| More than one race | 0 | 0 | 0 |
| Unknown or Not Reported | 0 | 1 | 1 |
| Injury duration(years) | Home-Based Exercise & Diet Group | Home-Based Diet Alone Group | Total |
|---|---|---|---|
| Mean | 5.5 ± 5.0 | 10.8 ± 8.4 | 8.2 ± 6.7 |
PDFs hosted by the registry, ClinicalTrials.gov.
Plan to share: No
Ran from Jun 2021 to primary completion in Jul 2024, 37 months.
Results were first posted in Dec 2025, 1 year 4 months after primary completion.
Of 790 non-industry interventional studies with no phase under Spinal Cord Injuries, half reached primary completion within 37 months of starting (the median), counting those still running; a quarter within 18 and three quarters within 65. This study's 37 months is close to that.
Counting every sponsor, half of 839 studies reached it within 36 months; a quarter within 17 and three quarters within 64.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Dec 2025. You cannot join it, but the record below documents what was studied.
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