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: Recruiting
• 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 (Estimated): 60
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Dinorah Rodriguez, RN, BSN; Phone Number: 305-243-2797; Email: dinorah@miami.edu

Study Locations

• United States
  • Florida
    • Miami, Florida, United States, 33136
      • Recruiting
      • University of Miami
      • Principal Investigator: Eduard Tiozzo, PhD
      • Contact: Dinorah Rodriguez, RN, BSN; Phone Number: 305-243-2797; Email: dinorah@med.miami.edu

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 percent Body fat	Percent body fat will be assessed in percentage using Dual Energy x-ray absorbency (DXA)	Baseline, 21 weeks
Change in Fat Mass	Absolute Fat mass (FM) and Absolute Fat free mass (FFM) will be assessed in kilograms using DXA	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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in High Density Lipoprotein cholesterol (HDL-C) level	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 measured from blood serum samples	Baseline, 21 weeks
Change in High sensitivity C-Reactive Protein (hsCRP) level	hsCRP will be measured from blood serum samples	Baseline, 21 weeks
Change in Lower Extremity Bone Mineral Density (BMD)	BMD will be measured using DXA	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 (Estimated): May 31, 2024
• Study Completion (Estimated): May 31, 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 (Actual): June 26, 2023
• Last Update Submitted That Met QC Criteria: June 22, 2023
• Last Verified: June 1, 2023

More Information

Terms related to this study

• Keywords: Exercise; Body Composition; Functional Electrical Stimulation
• Additional Relevant MeSH Terms: Glucose Metabolism Disorders; Metabolic Diseases; Central Nervous System Diseases; Nervous System Diseases; Neurologic Manifestations; Trauma, Nervous System; Spinal Cord Diseases; Insulin Resistance; Hyperinsulinism; Paralysis; Wounds and Injuries; Metabolic Syndrome; Spinal Cord Injuries; Quadriplegia; Paraplegia
• Other Study ID Numbers: 20190659; 6996 (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