Clinical trial NCT03495986: Spinal Cord Injury Exercise and Nutrition Conceptual Engagement
Official title: Spinal Cord Injury Exercise and Nutrition Conceptual Engagement (SCIENCE)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Spinal Cord Injuries
Metabolic Syndrome
Dietary Modification
Paraplegia
Tetraplegia
Keywords: Functional Electrical Stimulation
Exercise
Body Composition
Lead sponsor: University of Miami
Sponsor class: OTHER
Collaborators: name: Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
First posted: 2018-04-12
Enrollment: 39
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Change in percent Body fat
timeFrame: Baseline, 21 weeks
measure: Change in Fat Mass
timeFrame: Baseline, 21 weeks
measure: Change in Insulin Sensitivity (Si)
timeFrame: Baseline, 21 weeks
measure: Change in Glucose effectiveness (Sg)
timeFrame: Baseline, 21 weeks
measure: Change in Basal Metabolic Rate (BMR)
timeFrame: Baseline, 21 weeks
Secondary outcomes:
measure: Change in High Density Lipoprotein cholesterol (HDL-C) level
timeFrame: Baseline, 21 weeks
measure: Change in total cholesterol : HDL-C ratio
timeFrame: Baseline, 21 weeks
measure: Change in High sensitivity C-Reactive Protein (hsCRP) level
timeFrame: Baseline, 21 weeks
measure: Change in Lower Extremity Bone Mineral Density (BMD)
timeFrame: Baseline, 21 weeks
Other outcomes:
Locations:
city: Miami
country: United States
facility: University of Miami
state: Florida
Study officials:
affiliation: University of Miami
name: Eduard Tiozzo, PhD, MSCTI
role: PRINCIPAL_INVESTIGATOR
References: