Spinal Cord Injury Exercise and Nutrition Conceptual Engagement

Metabolic Syndrome Clinical Trial

— SCIENCE  

Official title:

Spinal Cord Injury Exercise and Nutrition Conceptual Engagement (SCIENCE)

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03495986
• Other study ID #: 20190659
• Secondary ID: R01HD091278-0169
• Status: Recruiting
• Phase: N/A
• Start date: June 10, 2021
• Est. completion date: May 31, 2024

Study information

• Verified date: June 2023
• Source: University of Miami
• Contact: Dinorah Rodriguez, RN, BSN
• Phone: 305-243-2797
• Email: dinorah[@]miami.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 60
• Est. completion date: May 31, 2024
• Est. primary completion date: May 31, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Dietary Modification
• Metabolic Syndrome
• Paraplegia
• Quadriplegia
• Spinal Cord Injuries
• Tetraplegia
• Wounds and Injuries

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.

Locations

Country	Name	City	State
United States	University of Miami	Miami	Florida

Sponsors (2)

Lead Sponsor	Collaborator
University of Miami	Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in percent Body fat	Percent body fat will be assessed in percentage using Dual Energy x-ray absorbency (DXA)	Baseline, 21 weeks
Primary	Change in Fat Mass	Absolute Fat mass (FM) and Absolute Fat free mass (FFM) will be assessed in kilograms using DXA	Baseline, 21 weeks
Primary	Change in Insulin Sensitivity (Si)	Insulin Sensitivity will be measured using intravenous glucose tolerance test (IVGTT)	Baseline, 21 weeks
Primary	Change in Glucose effectiveness (Sg)	Glucose Effectiveness will be measured using IVGTT	Baseline, 21 weeks
Primary	Change in Basal Metabolic Rate (BMR)	BMR will be measured by indirect calorimetry	Baseline, 21 weeks
Secondary	Change in High Density Lipoprotein cholesterol (HDL-C) level	HDL-C will be measured from blood serum samples	Baseline, 21 weeks
Secondary	Change in total cholesterol : HDL-C ratio	Total Cholesterol HDL-C ratio will be measured from blood serum samples	Baseline, 21 weeks
Secondary	Change in High sensitivity C-Reactive Protein (hsCRP) level	hsCRP will be measured from blood serum samples	Baseline, 21 weeks
Secondary	Change in Lower Extremity Bone Mineral Density (BMD)	BMD will be measured using DXA	Baseline, 21 weeks