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Spinal Cord Injury Exercise and Nutrition Conceptual Engagement
NA trial testing Functional Electrical Stimulation Leg Cycle Ergometry in Spinal Cord Injuries in 26 participants. Completed in 24 July 2024.
| Lead sponsor | University of Miami |
|---|---|
| Phase | NA |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | none |
| Primary purpose | treatment |
| Enrollment | 26 |
| Start date | 10 June 2021 |
| Primary completion | 24 July 2024 |
| Estimated completion | 24 July 2024 |
| Sites | 1 location across United States |
University of Miami
Adults 18 to 65, any sex, with Spinal Cord Injuries or Metabolic Syndrome. Patients with the condition only — healthy volunteers not accepted.
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
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.
| Group | Value | 95% CI |
|---|---|---|
| Exercise and Diet | 26.6 | ± 9.0 |
| Diet Only | 25.9 | ± 9.6 |
| Group | Value | 95% CI |
|---|---|---|
| Exercise and Diet | 22.0 | ± 5.3 |
| Diet Only | 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.
| Group | Value | 95% CI |
|---|---|---|
| Home-Based Exercise & Diet Group | 48.7 | ± 8.3 |
| Home-Based Diet Alone Group | 48.1 | ± 6.8 |
| Group | Value | 95% CI |
|---|---|---|
| Home-Based Exercise & Diet Group | 48.5 | ± 7.1 |
| Home-Based Diet Alone Group | 49.4 | ± 7.7 |
Insulin Sensitivity will be measured using intravenous glucose tolerance test (IVGTT)
| Group | Value | 95% CI |
|---|---|---|
| Home-Based Exercise & Diet Group | 4.1 | ± 9.9 |
| Home-Based Diet Alone Group | 3.2 | ± 4.3 |
| Group | Value | 95% CI |
|---|---|---|
| Home-Based Exercise & Diet Group | 1.8 | ± 1.5 |
| Home-Based Diet Alone Group | 1.5 | ± 1.4 |
Glucose Effectiveness will be measured using IVGTT
| Group | Value | 95% CI |
|---|---|---|
| Home-Based Exercise & Diet Group | 0.027 | ± 0.016 |
| Home-Based Diet Alone Group | 0.019 | ± 0.018 |
| Group | Value | 95% CI |
|---|---|---|
| Home-Based Exercise & Diet Group | 0.027 | ± 0.008 |
| Home-Based Diet Alone Group | 0.015 | ± 0.006 |
BMR will be measured by indirect calorimetry
| Group | Value | 95% CI |
|---|---|---|
| Home-Based Exercise & Diet Group | 1587.4 | ± 249.5 |
| Home-Based Diet Alone Group | 1502.5 | ± 234.6 |
| Group | Value | 95% CI |
|---|---|---|
| Home-Based Exercise & Diet Group | 1588.8 | ± 139.8 |
| Home-Based Diet Alone Group | 1510.0 | ± 178.4 |
HDL-C will be measured from blood serum samples
| Group | Value | 95% CI |
|---|---|---|
| Home-Based Exercise & Diet Group | 40.4 | ± 8.0 |
| Home-Based Diet Alone Group | 41.5 | ± 12.4 |
| Group | Value | 95% CI |
|---|---|---|
| Home-Based Exercise & Diet Group | 41.8 | ± 7.4 |
| Home-Based Diet Alone Group | 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.
| Group | Value | 95% CI |
|---|---|---|
| Exercise and Diet | 4.66 | ± 1.66 |
| Diet Only | 3.81 | ± 1.30 |
| Group | Value | 95% CI |
|---|---|---|
| Exercise and Diet | 4.53 | ± 1.46 |
| Diet Only | 3.95 | ± 1.22 |
hsCRP will be measured from blood serum samples
| Group | Value | 95% CI |
|---|---|---|
| Exercise and Diet | 8.8 | ± 12.4 |
| Diet Only | 8.8 | ± 10.2 |
| Group | Value | 95% CI |
|---|---|---|
| Exercise and Diet | 2.6 | ± 1.3 |
| Diet Only | 5.2 | ± 4.0 |
The changes in Bone Mineral Density will be measured using DXA scan
| Group | Value | 95% CI |
|---|---|---|
| Home-Based Exercise & Diet Group | 0.8 | ± 0.1 |
| Home-Based Diet Alone Group | 0.7 | ± 0.2 |
| Group | Value | 95% CI |
|---|---|---|
| Home-Based Exercise & Diet Group | 0.8 | ± 0.2 |
| Home-Based Diet Alone Group | 0.7 | ± 0.2 |
Time frame: 6 months. Reporting threshold: 5%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.
| Reaction | System | Home-Based Exercise & Diet… | Home-Based Diet Alone Group |
|---|---|---|---|
| Heart failure | Respiratory, thoracic and mediastinal disorders | — | — |
| Urinary tract infection (UTI) | Infections and infestations | — | — |
| Heterotopic ossification | Musculoskeletal and connective tissue disorders | — | — |
| Pulmonary embolism | Cardiac disorders | — | — |
| Hyponatremia | Metabolism and nutrition disorders | — | — |
| Autonomic Dysreflexia | Nervous system disorders | — | — |
| Skin and subcutaneous tissue disorders | — | — |
| Reaction | System | Home-Based Exercise & Diet… | Home-Based Diet Alone Group |
|---|---|---|---|
| Skin Irritation | Skin and subcutaneous tissue disorders | — | — |
Most-reported serious reactions: Heart failure, Urinary tract infection (UTI), Heterotopic ossification, Pulmonary embolism, Hyponatremia, Autonomic Dysreflexia, .
Data from ClinicalTrials.gov NCT03495986 adverse events section.
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.
1 peer-reviewed publication reference this trial (live from Europe PMC):
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