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Spinal Cord Injury Exercise and Nutrition Conceptual Engagement (SCIENCE)

Primary Purpose

Spinal Cord Injuries, Metabolic Syndrome, Dietary Modification

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Functional Electrical Stimulation Leg Cycle Ergometry
Diet
Sponsored by
University of Miami
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Spinal Cord Injuries focused on measuring Functional Electrical Stimulation, Exercise, Body Composition

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • University of MiamiRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Home-Based Exercise & Diet Group

Home-Based Diet Alone Group

Arm Description

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

Diet intervention

Outcomes

Primary Outcome Measures

Change in percent Body fat
Percent body fat will be assessed in percentage using Dual Energy x-ray absorbency (DXA)
Change in Fat Mass
Absolute Fat mass (FM) and Absolute Fat free mass (FFM) will be assessed in kilograms using DXA
Change in Insulin Sensitivity (Si)
Insulin Sensitivity will be measured using intravenous glucose tolerance test (IVGTT)
Change in Glucose effectiveness (Sg)
Glucose Effectiveness will be measured using IVGTT
Change in Basal Metabolic Rate (BMR)
BMR will be measured by indirect calorimetry

Secondary Outcome Measures

Change in High Density Lipoprotein cholesterol (HDL-C) level
HDL-C will be measured from blood serum samples
Change in total cholesterol : HDL-C ratio
Total Cholesterol HDL-C ratio will be measured from blood serum samples
Change in High sensitivity C-Reactive Protein (hsCRP) level
hsCRP will be measured from blood serum samples
Change in Lower Extremity Bone Mineral Density (BMD)
BMD will be measured using DXA

Full Information

First Posted
March 2, 2018
Last Updated
June 22, 2023
Sponsor
University of Miami
Collaborators
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
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1. Study Identification

Unique Protocol Identification Number
NCT03495986
Brief Title
Spinal Cord Injury Exercise and Nutrition Conceptual Engagement
Acronym
SCIENCE
Official Title
Spinal Cord Injury Exercise and Nutrition Conceptual Engagement (SCIENCE)
Study Type
Interventional

2. Study Status

Record Verification Date
June 2023
Overall Recruitment Status
Recruiting
Study Start Date
June 10, 2021 (Actual)
Primary Completion Date
May 31, 2024 (Anticipated)
Study Completion Date
May 31, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Miami
Collaborators
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

4. Oversight

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
Data Monitoring Committee
Yes

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Spinal Cord Injuries, Metabolic Syndrome, Dietary Modification, Paraplegia, Tetraplegia
Keywords
Functional Electrical Stimulation, Exercise, Body Composition

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
60 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Home-Based Exercise & Diet Group
Arm Type
Experimental
Arm Description
16-week home based functional electrical stimulation leg cycle ergometry exercise program and diet intervention
Arm Title
Home-Based Diet Alone Group
Arm Type
Placebo Comparator
Arm Description
Diet intervention
Intervention Type
Device
Intervention Name(s)
Functional Electrical Stimulation Leg Cycle Ergometry
Intervention Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Diet
Intervention Description
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.
Primary Outcome Measure Information:
Title
Change in percent Body fat
Description
Percent body fat will be assessed in percentage using Dual Energy x-ray absorbency (DXA)
Time Frame
Baseline, 21 weeks
Title
Change in Fat Mass
Description
Absolute Fat mass (FM) and Absolute Fat free mass (FFM) will be assessed in kilograms using DXA
Time Frame
Baseline, 21 weeks
Title
Change in Insulin Sensitivity (Si)
Description
Insulin Sensitivity will be measured using intravenous glucose tolerance test (IVGTT)
Time Frame
Baseline, 21 weeks
Title
Change in Glucose effectiveness (Sg)
Description
Glucose Effectiveness will be measured using IVGTT
Time Frame
Baseline, 21 weeks
Title
Change in Basal Metabolic Rate (BMR)
Description
BMR will be measured by indirect calorimetry
Time Frame
Baseline, 21 weeks
Secondary Outcome Measure Information:
Title
Change in High Density Lipoprotein cholesterol (HDL-C) level
Description
HDL-C will be measured from blood serum samples
Time Frame
Baseline, 21 weeks
Title
Change in total cholesterol : HDL-C ratio
Description
Total Cholesterol HDL-C ratio will be measured from blood serum samples
Time Frame
Baseline, 21 weeks
Title
Change in High sensitivity C-Reactive Protein (hsCRP) level
Description
hsCRP will be measured from blood serum samples
Time Frame
Baseline, 21 weeks
Title
Change in Lower Extremity Bone Mineral Density (BMD)
Description
BMD will be measured using DXA
Time Frame
Baseline, 21 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Dinorah Rodriguez, RN, BSN
Phone
305-243-2797
Email
dinorah@miami.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Eduard Tiozzo, PhD, MSCTI
Organizational Affiliation
University of Miami
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Miami
City
Miami
State/Province
Florida
ZIP/Postal Code
33136
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Dinorah Rodriguez, RN, BSN
Phone
305-243-2797
Email
dinorah@med.miami.edu
First Name & Middle Initial & Last Name & Degree
Eduard Tiozzo, PhD

12. IPD Sharing Statement

Plan to Share IPD
No

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Spinal Cord Injury Exercise and Nutrition Conceptual Engagement

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