Spinal Cord Injury Exercise and Nutrition Conceptual Engagement

NCT03495986 | Completed Results DMC FDA Device

• 3 other identifiers: 20190659R01HD091278-016996
• Study Type: interventional
• Target: 26
• Locations: 1 country
• Sites: 1

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.

Conditions

Spinal Cord Injuries; Metabolic Syndrome; Dietary Modification; Paraplegia; Tetraplegia

Keywords

Functional Electrical Stimulation; Exercise; Body Composition

Outcome Measures

Primary Outcomes (5)

• 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

Secondary Outcomes (4)

• High Density Lipoprotein Cholesterol (HDL-C)

  Baseline, 21 weeks

• Change in Total Cholesterol : HDL-C Ratio

  Baseline, 21 weeks

• C-Reactive Protein (hsCRP)

  Baseline, 21 weeks

• Lower Extremity Bone Mineral Density (BMD) - Femur

  Baseline, 21 weeks

Study Arms (2)

Home-Based Exercise & Diet Group

EXPERIMENTAL

16-week home based functional electrical stimulation leg cycle ergometry exercise program and diet intervention

Device: Functional Electrical Stimulation Leg Cycle Ergometry; Behavioral: Diet

Home-Based Diet Alone Group

PLACEBO COMPARATOR

Diet intervention

Behavioral: Diet

Interventions

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.

Home-Based Exercise & Diet Group

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.

Home-Based Diet Alone Group; Home-Based Exercise & Diet Group

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• \<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

Sponsors & Collaborators

• University of Miami: lead
• Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD): collaborator

Study Sites (1)

University of Miami

Miami, Florida, 33136, United States

Location

MeSH Terms

Conditions

Spinal Cord Injuries; Metabolic Syndrome; Paraplegia; Quadriplegia; Motor Activity

Interventions

Diet

Condition Hierarchy (Ancestors)

Spinal Cord Diseases; Central Nervous System Diseases; Nervous System Diseases; Trauma, Nervous System; Wounds and Injuries; Insulin Resistance; Hyperinsulinism; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Paralysis; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Behavior

Intervention Hierarchy (Ancestors)

Nutritional Physiological Phenomena; Diet, Food, and Nutrition; Physiological Phenomena

Results Point of Contact

• Title: Dr. Eduard Tiozzo
• Organization: University of Miami Miller School of Medicine

etiozzo@miami.edu

3052431633

Study Officials

• Eduard Tiozzo, PhD, MSCTI

  University of Miami

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Research Assistant Professor

Study Record Dates

• First Submitted: March 2, 2018
• First Posted: April 12, 2018
• Study Start: June 10, 2021
• Primary Completion: July 24, 2024
• Study Completion: July 24, 2024
• Last Updated: December 22, 2025
• Results First Posted: December 22, 2025

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)