N/A
N=26
Spinal Cord Injury Exercise and Nutrition Conceptual Engagement
Spinal Cord Injuries · Metabolic Syndrome · Dietary Modification · Paraplegia · Tetraplegia
Bottom Line
View on ClinicalTrials.gov: NCT03495986 ↗Enrolled (actual)
26
Serious AEs
26.9%
Results posted
Dec 2025
Primary outcome: Primary: Percent Body Fat Assessed by DXA at Baseline and 21 Weeks — 26.6; 25.9; 22.0; 25.6 % of body fat
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Functional Electrical Stimulation Leg Cycle Ergometry (Device); Diet (Behavioral)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- University of Miami
- Primary completion
- Jul 2024
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percent Body Fat Assessed by DXA at Baseline and 21 Weeks |
26.6; 25.9; 22.0; 25.6 | — |
| PRIMARY Fat Free Mass |
48.7; 48.1; 48.5; 49.4 | — |
| PRIMARY Change in Insulin Sensitivity (Si) |
4.1; 3.2; 1.8; 1.5 | — |
| PRIMARY Change in Glucose Effectiveness (Sg) |
0.027; 0.019; 0.027; 0.015 | — |
| PRIMARY Change in Basal Metabolic Rate (BMR) |
1587.4; 1502.5; 1588.8; 1510.0 | — |
| SECONDARY High Density Lipoprotein Cholesterol (HDL-C) |
40.4; 41.5; 41.8; 39.7 | — |
| SECONDARY Change in Total Cholesterol : HDL-C Ratio |
4.66; 3.81; 4.53; 3.95 | — |
| SECONDARY C-Reactive Protein (hsCRP) |
8.8; 8.8; 2.6; 5.2 | — |
| SECONDARY Lower Extremity Bone Mineral Density (BMD) - Femur |
0.8; 0.7; 0.8; 0.7 | — |
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.
Eligibility Criteria
Inclusion criteria
- 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
- 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)
- 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
Data sourced from ClinicalTrials.gov (NCT03495986). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.