Dietary Modification, Metabolic Syndrome, Paraplegia, Spinal Cord Injuries, Tetraplegia
Conditions
Keywords
Functional Electrical Stimulation, Exercise, Body Composition
Brief 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.
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.
Interventions
DEVICEFunctional 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.
BEHAVIORALDiet
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.
Sponsors
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
University of Miami
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
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 * \<5% change in body weight over the past 12 months
Exclusion criteria
* \<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) * 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Basal Metabolic Rate (BMR) | Baseline, 21 weeks | BMR will be measured by indirect calorimetry |
| Percent Body Fat Assessed by DXA at Baseline and 21 Weeks | 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 | 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) | Baseline, 21 weeks | Insulin Sensitivity will be measured using intravenous glucose tolerance test (IVGTT) |
| Change in Glucose Effectiveness (Sg) | Baseline, 21 weeks | Glucose Effectiveness will be measured using IVGTT |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in Total Cholesterol : HDL-C Ratio | Baseline, 21 weeks | 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. |
| C-Reactive Protein (hsCRP) | Baseline, 21 weeks | hsCRP will be measured from blood serum samples |
| Lower Extremity Bone Mineral Density (BMD) - Femur | Baseline, 21 weeks | The changes in Bone Mineral Density will be measured using DXA scan |
| High Density Lipoprotein Cholesterol (HDL-C) | Baseline, 21 weeks | HDL-C will be measured from blood serum samples |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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. | 13 |
| 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. | 13 |
| Total | 26 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Physician Decision | 1 | 0 |
| Overall Study | Withdrawal by Subject | 1 | 1 |
Baseline characteristics
| Characteristic | Home-Based Exercise & Diet Group | Total | Home-Based Diet Alone Group |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 13 Participants | 26 Participants | 13 Participants |
| Ethnicity (NIH/OMB) Hispanic or Latino | 7 Participants | 14 Participants | 7 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 5 Participants | 11 Participants | 6 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 1 Participants | 1 Participants | 0 Participants |
| Injury duration | 5.5 years STANDARD_DEVIATION 5 | 8.2 years STANDARD_DEVIATION 6.7 | 10.8 years STANDARD_DEVIATION 8.4 |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 4 Participants | 7 Participants | 3 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 1 Participants | 1 Participants |
| Race (NIH/OMB) White | 9 Participants | 18 Participants | 9 Participants |
| Sex: Female, Male Female | 2 Participants | 3 Participants | 1 Participants |
| Sex: Female, Male Male | 11 Participants | 23 Participants | 12 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 13 | 0 / 13 |
| other Total, other adverse events | 7 / 13 | 1 / 13 |
| serious Total, serious adverse events | 5 / 13 | 2 / 13 |
Outcome results
Primary
Change in Basal Metabolic Rate (BMR)
BMR will be measured by indirect calorimetry
Time frame: Baseline, 21 weeks
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Exercise and Diet | Change in Basal Metabolic Rate (BMR) | Baseline | 1587.4 kcal/day | Standard Deviation 249.5 |
| Exercise and Diet | Change in Basal Metabolic Rate (BMR) | 21 weeks | 1588.8 kcal/day | Standard Deviation 139.8 |
| Diet Only | Change in Basal Metabolic Rate (BMR) | Baseline | 1502.5 kcal/day | Standard Deviation 234.6 |
| Diet Only | Change in Basal Metabolic Rate (BMR) | 21 weeks | 1510.0 kcal/day | Standard Deviation 178.4 |
Primary
Change in Glucose Effectiveness (Sg)
Glucose Effectiveness will be measured using IVGTT
Time frame: Baseline, 21 weeks
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Exercise and Diet | Change in Glucose Effectiveness (Sg) | 21 weeks | 0.027 glucose clearance per minute (min-¹) | Standard Deviation 0.008 |
| Exercise and Diet | Change in Glucose Effectiveness (Sg) | Baseline | 0.027 glucose clearance per minute (min-¹) | Standard Deviation 0.016 |
| Diet Only | Change in Glucose Effectiveness (Sg) | Baseline | 0.019 glucose clearance per minute (min-¹) | Standard Deviation 0.018 |
| Diet Only | Change in Glucose Effectiveness (Sg) | 21 weeks | 0.015 glucose clearance per minute (min-¹) | Standard Deviation 0.006 |
Primary
Change in Insulin Sensitivity (Si)
Insulin Sensitivity will be measured using intravenous glucose tolerance test (IVGTT)
Time frame: Baseline, 21 weeks
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Exercise and Diet | Change in Insulin Sensitivity (Si) | Baseline | 4.1 min^-1/microU/mL^-1) _x10^-4 | Standard Deviation 9.9 |
| Exercise and Diet | Change in Insulin Sensitivity (Si) | 21 weeks | 1.8 min^-1/microU/mL^-1) _x10^-4 | Standard Deviation 1.5 |
| Diet Only | Change in Insulin Sensitivity (Si) | Baseline | 3.2 min^-1/microU/mL^-1) _x10^-4 | Standard Deviation 4.3 |
| Diet Only | Change in Insulin Sensitivity (Si) | 21 weeks | 1.5 min^-1/microU/mL^-1) _x10^-4 | Standard Deviation 1.4 |
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.
Time frame: Baseline, 21 weeks
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Exercise and Diet | Fat Free Mass | Baseline | 48.7 kilograms | Standard Deviation 8.3 |
| Exercise and Diet | Fat Free Mass | 21 weeks | 48.5 kilograms | Standard Deviation 7.1 |
| Diet Only | Fat Free Mass | Baseline | 48.1 kilograms | Standard Deviation 6.8 |
| Diet Only | Fat Free Mass | 21 weeks | 49.4 kilograms | Standard Deviation 7.7 |
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.
Time frame: Baseline, 21 weeks
Population: Percent body fat was analyzed using DXA.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Exercise and Diet | Percent Body Fat Assessed by DXA at Baseline and 21 Weeks | Baseline | 26.6 % of body fat | Standard Deviation 9 |
| Exercise and Diet | Percent Body Fat Assessed by DXA at Baseline and 21 Weeks | 21 weeks | 22.0 % of body fat | Standard Deviation 5.3 |
| Diet Only | Percent Body Fat Assessed by DXA at Baseline and 21 Weeks | Baseline | 25.9 % of body fat | Standard Deviation 9.6 |
| Diet Only | Percent Body Fat Assessed by DXA at Baseline and 21 Weeks | 21 weeks | 25.6 % of body fat | Standard Deviation 6.9 |
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.
Time frame: Baseline, 21 weeks
Population: Ratio
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Exercise and Diet | Change in Total Cholesterol : HDL-C Ratio | 21 weeks | 4.53 ratio | Standard Deviation 1.46 |
| Exercise and Diet | Change in Total Cholesterol : HDL-C Ratio | Baseline | 4.66 ratio | Standard Deviation 1.66 |
| Diet Only | Change in Total Cholesterol : HDL-C Ratio | Baseline | 3.81 ratio | Standard Deviation 1.3 |
| Diet Only | Change in Total Cholesterol : HDL-C Ratio | 21 weeks | 3.95 ratio | Standard Deviation 1.22 |
Secondary
C-Reactive Protein (hsCRP)
hsCRP will be measured from blood serum samples
Time frame: Baseline, 21 weeks
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Exercise and Diet | C-Reactive Protein (hsCRP) | Baseline | 8.8 mg/L | Standard Deviation 12.4 |
| Exercise and Diet | C-Reactive Protein (hsCRP) | 21 weeks | 2.6 mg/L | Standard Deviation 1.3 |
| Diet Only | C-Reactive Protein (hsCRP) | Baseline | 8.8 mg/L | Standard Deviation 10.2 |
| Diet Only | C-Reactive Protein (hsCRP) | 21 weeks | 5.2 mg/L | Standard Deviation 4 |
Secondary
High Density Lipoprotein Cholesterol (HDL-C)
HDL-C will be measured from blood serum samples
Time frame: Baseline, 21 weeks
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Exercise and Diet | High Density Lipoprotein Cholesterol (HDL-C) | Baseline | 40.4 mg/dl | Standard Deviation 8 |
| Exercise and Diet | High Density Lipoprotein Cholesterol (HDL-C) | 21 weeks | 41.8 mg/dl | Standard Deviation 7.4 |
| Diet Only | High Density Lipoprotein Cholesterol (HDL-C) | Baseline | 41.5 mg/dl | Standard Deviation 12.4 |
| Diet Only | High Density Lipoprotein Cholesterol (HDL-C) | 21 weeks | 39.7 mg/dl | Standard Deviation 10.3 |
Secondary
Lower Extremity Bone Mineral Density (BMD) - Femur
The changes in Bone Mineral Density will be measured using DXA scan
Time frame: Baseline, 21 weeks
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Exercise and Diet | Lower Extremity Bone Mineral Density (BMD) - Femur | Baseline | 0.8 g/cm³ | Standard Deviation 0.1 |
| Exercise and Diet | Lower Extremity Bone Mineral Density (BMD) - Femur | 21 weeks | 0.8 g/cm³ | Standard Deviation 0.2 |
| Diet Only | Lower Extremity Bone Mineral Density (BMD) - Femur | Baseline | 0.7 g/cm³ | Standard Deviation 0.2 |
| Diet Only | Lower Extremity Bone Mineral Density (BMD) - Femur | 21 weeks | 0.7 g/cm³ | Standard Deviation 0.2 |