Trial Outcomes & Findings for Spinal Cord Injury Exercise and Nutrition Conceptual Engagement (NCT NCT03495986)
NCT ID: NCT03495986
Last Updated: 2025-12-22
Results Overview
Glucose Effectiveness will be measured using IVGTT
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
26 participants
Primary outcome timeframe
Baseline, 21 weeks
Results posted on
2025-12-22
Participant Flow
Participant milestones
| Measure |
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.
|
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.
|
|---|---|---|
|
Overall Study
STARTED
|
13
|
13
|
|
Overall Study
COMPLETED
|
10
|
12
|
|
Overall Study
NOT COMPLETED
|
3
|
1
|
Reasons for withdrawal
| Measure |
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.
|
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.
|
|---|---|---|
|
Overall Study
Physician Decision
|
1
|
0
|
|
Overall Study
Withdrawal by Subject
|
1
|
0
|
Baseline Characteristics
Spinal Cord Injury Exercise and Nutrition Conceptual Engagement
Baseline characteristics by cohort
| Measure |
Home-Based Exercise & Diet Group
n=13 Participants
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.
|
Home-Based Diet Alone Group
n=13 Participants
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.
|
Total
n=26 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=18 Participants
|
0 Participants
n=102 Participants
|
0 Participants
n=30 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
13 Participants
n=18 Participants
|
13 Participants
n=102 Participants
|
26 Participants
n=30 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=18 Participants
|
0 Participants
n=102 Participants
|
0 Participants
n=30 Participants
|
|
Sex: Female, Male
Female
|
2 Participants
n=18 Participants
|
1 Participants
n=102 Participants
|
3 Participants
n=30 Participants
|
|
Sex: Female, Male
Male
|
11 Participants
n=18 Participants
|
12 Participants
n=102 Participants
|
23 Participants
n=30 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
7 Participants
n=18 Participants
|
7 Participants
n=102 Participants
|
14 Participants
n=30 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
5 Participants
n=18 Participants
|
6 Participants
n=102 Participants
|
11 Participants
n=30 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=18 Participants
|
0 Participants
n=102 Participants
|
1 Participants
n=30 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=18 Participants
|
0 Participants
n=102 Participants
|
0 Participants
n=30 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=18 Participants
|
0 Participants
n=102 Participants
|
0 Participants
n=30 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=18 Participants
|
0 Participants
n=102 Participants
|
0 Participants
n=30 Participants
|
|
Race (NIH/OMB)
Black or African American
|
4 Participants
n=18 Participants
|
3 Participants
n=102 Participants
|
7 Participants
n=30 Participants
|
|
Race (NIH/OMB)
White
|
9 Participants
n=18 Participants
|
9 Participants
n=102 Participants
|
18 Participants
n=30 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=18 Participants
|
0 Participants
n=102 Participants
|
0 Participants
n=30 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=18 Participants
|
1 Participants
n=102 Participants
|
1 Participants
n=30 Participants
|
|
Injury duration
|
5.5 years
STANDARD_DEVIATION 5.0 • n=18 Participants
|
10.8 years
STANDARD_DEVIATION 8.4 • n=102 Participants
|
8.2 years
STANDARD_DEVIATION 6.7 • n=30 Participants
|
PRIMARY outcome
Timeframe: Baseline, 21 weeksPopulation: Percent body fat was analyzed using DXA.
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.
Outcome measures
| Measure |
Exercise and Diet
n=13 Participants
It included exercise (functional electrical stimulation leg cycling) and diet (nutrition counseling from a registered dietitian).
The exercise group completed 3-5 remotely monitored weekly sessions, targeting ≥200 minutes of active exercise at 70% maximum heart rate. Dietary counseling was done weekly, one-on-one and it aimed to achieve a 200 kcal/day deficit from baseline energy intake.
|
Diet Only
n=13 Participants
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.
|
|---|---|---|
|
Percent Body Fat Assessed by DXA at Baseline and 21 Weeks
Baseline
|
26.6 % of body fat
Standard Deviation 9.0
|
25.9 % of body fat
Standard Deviation 9.6
|
|
Percent Body Fat Assessed by DXA at Baseline and 21 Weeks
21 weeks
|
22.0 % of body fat
Standard Deviation 5.3
|
25.6 % of body fat
Standard Deviation 6.9
|
PRIMARY outcome
Timeframe: Baseline, 21 weeksBody 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.
Outcome measures
| Measure |
Exercise and Diet
n=13 Participants
It included exercise (functional electrical stimulation leg cycling) and diet (nutrition counseling from a registered dietitian).
The exercise group completed 3-5 remotely monitored weekly sessions, targeting ≥200 minutes of active exercise at 70% maximum heart rate. Dietary counseling was done weekly, one-on-one and it aimed to achieve a 200 kcal/day deficit from baseline energy intake.
|
Diet Only
n=13 Participants
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.
|
|---|---|---|
|
Fat Free Mass
21 weeks
|
48.5 kilograms
Standard Deviation 7.1
|
49.4 kilograms
Standard Deviation 7.7
|
|
Fat Free Mass
Baseline
|
48.7 kilograms
Standard Deviation 8.3
|
48.1 kilograms
Standard Deviation 6.8
|
PRIMARY outcome
Timeframe: Baseline, 21 weeksInsulin Sensitivity will be measured using intravenous glucose tolerance test (IVGTT)
Outcome measures
| Measure |
Exercise and Diet
n=13 Participants
It included exercise (functional electrical stimulation leg cycling) and diet (nutrition counseling from a registered dietitian).
The exercise group completed 3-5 remotely monitored weekly sessions, targeting ≥200 minutes of active exercise at 70% maximum heart rate. Dietary counseling was done weekly, one-on-one and it aimed to achieve a 200 kcal/day deficit from baseline energy intake.
|
Diet Only
n=13 Participants
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.
|
|---|---|---|
|
Change in Insulin Sensitivity (Si)
21 weeks
|
1.8 min^-1/microU/mL^-1) _x10^-4
Standard Deviation 1.5
|
1.5 min^-1/microU/mL^-1) _x10^-4
Standard Deviation 1.4
|
|
Change in Insulin Sensitivity (Si)
Baseline
|
4.1 min^-1/microU/mL^-1) _x10^-4
Standard Deviation 9.9
|
3.2 min^-1/microU/mL^-1) _x10^-4
Standard Deviation 4.3
|
PRIMARY outcome
Timeframe: Baseline, 21 weeksGlucose Effectiveness will be measured using IVGTT
Outcome measures
| Measure |
Exercise and Diet
n=13 Participants
It included exercise (functional electrical stimulation leg cycling) and diet (nutrition counseling from a registered dietitian).
The exercise group completed 3-5 remotely monitored weekly sessions, targeting ≥200 minutes of active exercise at 70% maximum heart rate. Dietary counseling was done weekly, one-on-one and it aimed to achieve a 200 kcal/day deficit from baseline energy intake.
|
Diet Only
n=13 Participants
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.
|
|---|---|---|
|
Change in Glucose Effectiveness (Sg)
Baseline
|
0.027 glucose clearance per minute (min-¹)
Standard Deviation 0.016
|
0.019 glucose clearance per minute (min-¹)
Standard Deviation 0.018
|
|
Change in Glucose Effectiveness (Sg)
21 weeks
|
0.027 glucose clearance per minute (min-¹)
Standard Deviation 0.008
|
0.015 glucose clearance per minute (min-¹)
Standard Deviation 0.006
|
PRIMARY outcome
Timeframe: Baseline, 21 weeksBMR will be measured by indirect calorimetry
Outcome measures
| Measure |
Exercise and Diet
n=13 Participants
It included exercise (functional electrical stimulation leg cycling) and diet (nutrition counseling from a registered dietitian).
The exercise group completed 3-5 remotely monitored weekly sessions, targeting ≥200 minutes of active exercise at 70% maximum heart rate. Dietary counseling was done weekly, one-on-one and it aimed to achieve a 200 kcal/day deficit from baseline energy intake.
|
Diet Only
n=13 Participants
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.
|
|---|---|---|
|
Change in Basal Metabolic Rate (BMR)
Baseline
|
1587.4 kcal/day
Standard Deviation 249.5
|
1502.5 kcal/day
Standard Deviation 234.6
|
|
Change in Basal Metabolic Rate (BMR)
21 weeks
|
1588.8 kcal/day
Standard Deviation 139.8
|
1510.0 kcal/day
Standard Deviation 178.4
|
SECONDARY outcome
Timeframe: Baseline, 21 weeksHDL-C will be measured from blood serum samples
Outcome measures
| Measure |
Exercise and Diet
n=13 Participants
It included exercise (functional electrical stimulation leg cycling) and diet (nutrition counseling from a registered dietitian).
The exercise group completed 3-5 remotely monitored weekly sessions, targeting ≥200 minutes of active exercise at 70% maximum heart rate. Dietary counseling was done weekly, one-on-one and it aimed to achieve a 200 kcal/day deficit from baseline energy intake.
|
Diet Only
n=13 Participants
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.
|
|---|---|---|
|
High Density Lipoprotein Cholesterol (HDL-C)
Baseline
|
40.4 mg/dl
Standard Deviation 8.0
|
41.5 mg/dl
Standard Deviation 12.4
|
|
High Density Lipoprotein Cholesterol (HDL-C)
21 weeks
|
41.8 mg/dl
Standard Deviation 7.4
|
39.7 mg/dl
Standard Deviation 10.3
|
SECONDARY outcome
Timeframe: Baseline, 21 weeksPopulation: 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.
Outcome measures
| Measure |
Exercise and Diet
n=13 Participants
It included exercise (functional electrical stimulation leg cycling) and diet (nutrition counseling from a registered dietitian).
The exercise group completed 3-5 remotely monitored weekly sessions, targeting ≥200 minutes of active exercise at 70% maximum heart rate. Dietary counseling was done weekly, one-on-one and it aimed to achieve a 200 kcal/day deficit from baseline energy intake.
|
Diet Only
n=13 Participants
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.
|
|---|---|---|
|
Change in Total Cholesterol : HDL-C Ratio
Baseline
|
4.66 ratio
Standard Deviation 1.66
|
3.81 ratio
Standard Deviation 1.30
|
|
Change in Total Cholesterol : HDL-C Ratio
21 weeks
|
4.53 ratio
Standard Deviation 1.46
|
3.95 ratio
Standard Deviation 1.22
|
SECONDARY outcome
Timeframe: Baseline, 21 weekshsCRP will be measured from blood serum samples
Outcome measures
| Measure |
Exercise and Diet
n=13 Participants
It included exercise (functional electrical stimulation leg cycling) and diet (nutrition counseling from a registered dietitian).
The exercise group completed 3-5 remotely monitored weekly sessions, targeting ≥200 minutes of active exercise at 70% maximum heart rate. Dietary counseling was done weekly, one-on-one and it aimed to achieve a 200 kcal/day deficit from baseline energy intake.
|
Diet Only
n=13 Participants
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.
|
|---|---|---|
|
C-Reactive Protein (hsCRP)
Baseline
|
8.8 mg/L
Standard Deviation 12.4
|
8.8 mg/L
Standard Deviation 10.2
|
|
C-Reactive Protein (hsCRP)
21 weeks
|
2.6 mg/L
Standard Deviation 1.3
|
5.2 mg/L
Standard Deviation 4.0
|
SECONDARY outcome
Timeframe: Baseline, 21 weeksThe changes in Bone Mineral Density will be measured using DXA scan
Outcome measures
| Measure |
Exercise and Diet
n=13 Participants
It included exercise (functional electrical stimulation leg cycling) and diet (nutrition counseling from a registered dietitian).
The exercise group completed 3-5 remotely monitored weekly sessions, targeting ≥200 minutes of active exercise at 70% maximum heart rate. Dietary counseling was done weekly, one-on-one and it aimed to achieve a 200 kcal/day deficit from baseline energy intake.
|
Diet Only
n=13 Participants
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.
|
|---|---|---|
|
Lower Extremity Bone Mineral Density (BMD) - Femur
Baseline
|
0.8 g/cm³
Standard Deviation 0.1
|
0.7 g/cm³
Standard Deviation 0.2
|
|
Lower Extremity Bone Mineral Density (BMD) - Femur
21 weeks
|
0.8 g/cm³
Standard Deviation 0.2
|
0.7 g/cm³
Standard Deviation 0.2
|
Adverse Events
Home-Based Exercise & Diet Group
Serious events: 5 serious events
Other events: 7 other events
Deaths: 0 deaths
Home-Based Diet Alone Group
Serious events: 2 serious events
Other events: 1 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Home-Based Exercise & Diet Group
n=13 participants at risk
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.
|
Home-Based Diet Alone Group
n=13 participants at risk
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.
|
|---|---|---|
|
Respiratory, thoracic and mediastinal disorders
Heart failure
|
7.7%
1/13 • Number of events 1 • 6 months
|
0.00%
0/13 • 6 months
|
|
Infections and infestations
Urinary tract infection (UTI)
|
7.7%
1/13 • Number of events 1 • 6 months
|
7.7%
1/13 • Number of events 1 • 6 months
|
|
Skin and subcutaneous tissue disorders
|
0.00%
0/13 • 6 months
|
0.00%
0/13 • 6 months
|
|
Musculoskeletal and connective tissue disorders
Heterotopic ossification
|
7.7%
1/13 • Number of events 1 • 6 months
|
0.00%
0/13 • 6 months
|
|
Cardiac disorders
Pulmonary embolism
|
7.7%
1/13 • Number of events 1 • 6 months
|
0.00%
0/13 • 6 months
|
|
Metabolism and nutrition disorders
Hyponatremia
|
7.7%
1/13 • Number of events 1 • 6 months
|
0.00%
0/13 • 6 months
|
|
Nervous system disorders
Autonomic Dysreflexia
|
0.00%
0/13 • 6 months
|
7.7%
1/13 • Number of events 1 • 6 months
|
Other adverse events
| Measure |
Home-Based Exercise & Diet Group
n=13 participants at risk
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.
|
Home-Based Diet Alone Group
n=13 participants at risk
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.
|
|---|---|---|
|
Skin and subcutaneous tissue disorders
Skin Irritation
|
53.8%
7/13 • Number of events 9 • 6 months
|
7.7%
1/13 • Number of events 1 • 6 months
|
Additional Information
Dr. Eduard Tiozzo
University of Miami Miller School of Medicine
Phone: 3052431633
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place