Spinal Cord Injury Exercise and Nutrition Conceptual Engagement (SCIENCE)

Spinal Cord Injury Exercise and Nutrition Conceptual Engagement (SCIENCE)

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.

Study Overview

• Status: Completed
• Conditions: Metabolic Syndrome; Spinal Cord Injuries; Tetraplegia; Dietary Modification; Paraplegia
• Intervention / Treatment: Device: Functional Electrical Stimulation Leg Cycle Ergometry; Behavioral: Diet

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.

• Study Type: Interventional
• Enrollment (Actual): 26
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Florida
    • Miami, Florida, United States, 33136
      • University of Miami

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Home-Based Exercise & Diet Group; 16-week home based functional electrical stimulation leg cycle ergometry exercise program and diet intervention	Device: 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.; Behavioral: 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.
Placebo Comparator: Home-Based Diet Alone Group; Diet intervention	Behavioral: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in Insulin Sensitivity (Si)	Insulin Sensitivity will be measured using intravenous glucose tolerance test (IVGTT)	Baseline, 21 weeks
Change in Basal Metabolic Rate (BMR)	BMR will be measured by indirect calorimetry	Baseline, 21 weeks
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 Glucose Effectiveness (Sg)	Glucose Effectiveness will be measured using IVGTT	Baseline, 21 weeks

Secondary Outcome Measures

Outcome Measure	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.	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

Collaborators and Investigators

• Sponsor: University of Miami
• Collaborators: Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
• Investigators: Principal Investigator: Eduard Tiozzo, PhD, MSCTI, University of Miami

Study record dates

Study Major Dates

• Study Start (Actual): June 10, 2021
• Primary Completion (Actual): July 24, 2024
• Study Completion (Actual): July 24, 2024

Study Registration Dates

• First Submitted: March 2, 2018
• First Submitted That Met QC Criteria: April 11, 2018
• First Posted (Actual): April 12, 2018

Study Record Updates

• Last Update Posted (Estimated): December 22, 2025
• Last Update Submitted That Met QC Criteria: December 4, 2025
• Last Verified: December 1, 2025

More Information

Terms related to this study

• Keywords: Exercise; Body Composition; Functional Electrical Stimulation
• Additional Relevant MeSH Terms: Neurologic Manifestations; Central Nervous System Diseases; Nervous System Diseases; Wounds and Injuries; Metabolic Diseases; Glucose Metabolism Disorders; Insulin Resistance; Hyperinsulinism; Trauma, Nervous System; Spinal Cord Diseases; Paralysis; Pathological Conditions, Signs and Symptoms; Behavior; Nutritional and Metabolic Diseases; Signs and Symptoms; Metabolic Syndrome; Spinal Cord Injuries; Quadriplegia; Paraplegia; Motor Activity; Diet, Food, and Nutrition; Physiological Phenomena; Nutritional Physiological Phenomena; Diet
• Other Study ID Numbers: 20190659; 6996 (Other Identifier: Pennsylvania State University); R01HD091278-01 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No