Spinal Cord Injury Exercise and Nutrition Conceptual Engagement

Not Applicable

Completed

• Conditions: Spinal Cord Injuries; Metabolic Syndrome; Paraplegia; Dietary Modification; Tetraplegia

• Registration Number: NCT03495986
• Lead Sponsor: University of Miami

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2018-3-2
• Last Update Posted: 2 September 2024

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 39

Inclusion Criteria

<br><br> - Adults 18-65 years of age (inclusive)<br><br> - Sex: male or female<br><br> - Women of child-bearing potential who agree to refrain from getting pregnant during<br> the trial<br><br> - C4-T4 motor complete (AIS A&B) spinal cord injury for duration greater than 12<br> months<br><br> - <5% change in body weight over the past 12 months<br><br>Exclusion criteria:<br><br> - <22% body fat<br><br> - Unresponsive to neurostimulation<br><br> - Those who have participated in an FES or ACE exercise program (>60 minutes/week)<br> within the past 3 months<br><br> - Known orthopaedic limitations<br><br> - Coronary artery disease<br><br> - Type 1 diabetes mellitus, insulin-requiring Type 2 or untreated diabetes mellitus<br> (fasting glucose>126 or HgbA1c>7.0)<br><br> - Uncompensated Hypothyroidism (Stable on medication >1 year or not on medication)<br><br> - Renal disease<br><br> - Uncontrolled autonomic dysreflexia, recent (within 3 months)<br><br> - Deep vein thrombosis<br><br> - Pressure ulcers > Grade II<br><br> - Decisional impairment<br><br> - Any potential causes of autonomic dysreflexia at the discretion of the PI<br><br> - Prisoners<br><br> - Pregnant or nursing women

Exclusion Criteria

Not provided

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Change in percent Body fat;Change in Fat Mass;Change in Insulin Sensitivity (Si);Change in Glucose effectiveness (Sg);Change in Basal Metabolic Rate (BMR)

Secondary Outcome Measures

Name	Time	Method
Change in High Density Lipoprotein cholesterol (HDL-C) level;Change in total cholesterol : HDL-C ratio;Change in High sensitivity C-Reactive Protein (hsCRP) level;Change in Lower Extremity Bone Mineral Density (BMD)