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| ID | Type | Description | Link |
|---|---|---|---|
| R01HD091278-01 | U.S. NIH Grant/Contract | View source | |
| 6996 | Other Identifier | Pennsylvania State University |
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| Name | Class |
|---|---|
| Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) | NIH |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Home-Based Exercise & Diet Group | Experimental | 16-week home based functional electrical stimulation leg cycle ergometry exercise program and diet intervention |
|
| Home-Based Diet Alone Group | Placebo Comparator | Diet intervention |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Functional Electrical Stimulation Leg Cycle Ergometry | Device | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 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. | Baseline, 21 weeks |
| Change in Insulin Sensitivity (Si) | Insulin Sensitivity will be measured using intravenous glucose tolerance test (IVGTT) | Baseline, 21 weeks |
| Change in Glucose Effectiveness (Sg) | Glucose Effectiveness will be measured using IVGTT | Baseline, 21 weeks |
| Change in Basal Metabolic Rate (BMR) | BMR will be measured by indirect calorimetry | Baseline, 21 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| High Density Lipoprotein Cholesterol (HDL-C) | HDL-C will be measured from blood serum samples | 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. |
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Inclusion criteria:
Exclusion criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Eduard Tiozzo, PhD, MSCTI | University of Miami | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Miami | Miami | Florida | 33136 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | Home-Based Exercise & Diet Group | 16-week home based functional electrical stimulation leg cycle ergometry exercise program and diet intervention Functional Electrical Stimulation Leg Cycle Ergometry: 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. Diet: 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. |
| FG001 | Home-Based Diet Alone Group | Diet intervention Diet: 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. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Home-Based Exercise & Diet Group | 16-week home based functional electrical stimulation leg cycle ergometry exercise program and diet intervention Functional Electrical Stimulation Leg Cycle Ergometry: 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. Diet: 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. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | Percent body fat was analyzed using DXA. | Posted | Mean | Standard Deviation | % of body fat | Baseline, 21 weeks |
|
6 months
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Home-Based Exercise & Diet Group | 16-week home based functional electrical stimulation leg cycle ergometry exercise program and diet intervention Functional Electrical Stimulation Leg Cycle Ergometry: 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. Diet: 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. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Heart failure | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Skin Irritation | Skin and subcutaneous tissue disorders | Systematic Assessment | 7 participants had skin issues in exercise + diet group. However, 2 participants with skin issues in this group were unrelated to the intervention. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Eduard Tiozzo | University of Miami Miller School of Medicine | 3052431633 | etiozzo@miami.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Jul 18, 2025 | Sep 3, 2025 | Prot_SAP_001.pdf |
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| ID | Term |
|---|---|
| D013119 | Spinal Cord Injuries |
| D024821 | Metabolic Syndrome |
| D010264 | Paraplegia |
| D011782 | Quadriplegia |
| D009043 | Motor Activity |
| ID | Term |
|---|---|
| D013118 | Spinal Cord Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D020196 | Trauma, Nervous System |
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| ID | Term |
|---|---|
| D004032 | Diet |
| ID | Term |
|---|---|
| D009747 | Nutritional Physiological Phenomena |
| D000066888 | Diet, Food, and Nutrition |
| D010829 | Physiological Phenomena |
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| Diet | Behavioral | 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. |
|
| Baseline, 21 weeks |
| C-Reactive Protein (hsCRP) | hsCRP will be measured from blood serum samples | Baseline, 21 weeks |
| Lower Extremity Bone Mineral Density (BMD) - Femur | The changes in Bone Mineral Density will be measured using DXA scan | Baseline, 21 weeks |
| Withdrawal by Subject |
|
| BG001 | Home-Based Diet Alone Group | Diet intervention Diet: 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. |
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Injury duration | Mean | Standard Deviation | years |
|
| OG001 |
| Diet Only |
It included nutrition counseling from a registered dietitian (weekly and one-on-one), aiming to achieve a 200 kcal/day deficit from baseline energy intake. |
|
|
| Primary | 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. | Posted | Mean | Standard Deviation | kilograms | Baseline, 21 weeks |
|
|
|
| Primary | Change in Insulin Sensitivity (Si) | Insulin Sensitivity will be measured using intravenous glucose tolerance test (IVGTT) | Posted | Mean | Standard Deviation | min^-1/microU/mL^-1) _x10^-4 | Baseline, 21 weeks |
|
|
|
| Primary | Change in Glucose Effectiveness (Sg) | Glucose Effectiveness will be measured using IVGTT | Posted | Mean | Standard Deviation | glucose clearance per minute (min-¹) | Baseline, 21 weeks |
|
|
|
| Primary | Change in Basal Metabolic Rate (BMR) | BMR will be measured by indirect calorimetry | Posted | Mean | Standard Deviation | kcal/day | Baseline, 21 weeks |
|
|
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| Secondary | High Density Lipoprotein Cholesterol (HDL-C) | HDL-C will be measured from blood serum samples | Posted | Mean | Standard Deviation | mg/dl | Baseline, 21 weeks |
|
|
|
| Secondary | 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. | Ratio | Posted | Mean | Standard Deviation | ratio | Baseline, 21 weeks |
|
|
|
| Secondary | C-Reactive Protein (hsCRP) | hsCRP will be measured from blood serum samples | Posted | Mean | Standard Deviation | mg/L | Baseline, 21 weeks |
|
|
|
| Secondary | Lower Extremity Bone Mineral Density (BMD) - Femur | The changes in Bone Mineral Density will be measured using DXA scan | Posted | Mean | Standard Deviation | g/cm³ | Baseline, 21 weeks |
|
|
|
| 0 |
| 13 |
| 5 |
| 13 |
| 7 |
| 13 |
| EG001 | Home-Based Diet Alone Group | Diet intervention Diet: 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. | 0 | 13 | 2 | 13 | 1 | 13 |
| Urinary tract infection (UTI) | Infections and infestations | Non-systematic Assessment |
|
| Skin and subcutaneous tissue disorders | Non-systematic Assessment |
|
| Heterotopic ossification | Musculoskeletal and connective tissue disorders | Non-systematic Assessment |
|
| Pulmonary embolism | Cardiac disorders | Non-systematic Assessment |
|
| Hyponatremia | Metabolism and nutrition disorders | Non-systematic Assessment |
|
| Autonomic Dysreflexia | Nervous system disorders | Non-systematic Assessment |
|
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| D014947 | Wounds and Injuries |
| D007333 | Insulin Resistance |
| D006946 | Hyperinsulinism |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D010243 | Paralysis |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D001519 | Behavior |