title: Effects of Testosterone and Evoked Resistance Exercise after Spinal Cord Injury (TEREX-SCI): study protocol for a randomised controlled trial.
abstract: Individuals with spinal cord injury (SCI) are at a lifelong risk of obesity and chronic metabolic disorders including insulin resistance and dyslipidemia. Within a few weeks of injury, there is a significant decline in whole body fat-free mass, particularly lower extremity skeletal muscle mass, and subsequent increase in fat mass (FM). This is accompanied by a decrease in anabolic hormones including testosterone. Testosterone replacement therapy (TRT) has been shown to increase skeletal muscle mass and improve metabolic profile. Additionally, resistance training (RT) has been shown to increase lean mass and reduce metabolic disturbances in SCI and other clinical populations.
  
  
  
  26 individuals with chronic, motor complete SCI between 18 and 50 years old were randomly assigned to a RT+TRT group (n=13) or a TRT group (n=13). 22 participants completed the initial 16-week training phase of the study and 4 participants withdrew. 12 participants of the 22 completed 16 weeks of detraining. The TRT was provided via transdermal testosterone patches (4-6 mg/day). The RT+TRT group had 16 weeks of supervised unilateral progressive RT using surface neuromuscular electrical stimulation with ankle weights. This study will investigate the effects of evoked RT+TRT or TRT alone on body composition (muscle cross-sectional area, visceral adipose tissue, %FM) and metabolic profile (glucose and lipid metabolism) in individuals with motor complete SCI. Findings from this study may help in designing exercise therapies to alleviate the deterioration in body composition after SCI and decrease the incidence of metabolic disorders in this clinical population.
  
  
  
  The study is currently approved by the McGuire VA Medical Center and Virginia Commonwealth University. All participants read and signed approved consent forms. Results will be submitted to peer-reviewed journals and presented at national and international conferences.
  
  
  
  Pre-result, NCT01652040.
authors.affiliation: Spinal Cord Injury and Disorders Center, Hunter Holmes McGuire VAMC, Richmond, Virginia, USA.|Department of Physical Medicine and Rehabilitation, Virginia Commonwealth University, Richmond, Virginia, USA.
authors.forename: Ashraf S
authors.initials: AS
authors.lastname: Gorgey
authors.affiliation: Spinal Cord Injury and Disorders Center, Hunter Holmes McGuire VAMC, Richmond, Virginia, USA.
authors.forename: Refka E
authors.initials: RE
authors.lastname: Khalil
authors.affiliation: Endocrinology Service, Hunter Holmes McGuire VA Medical Center, Richmond, Virginia, USA.|Endocrine Division, Virginia Commonwealth University School of Medicine¸ Richmond, Virginia, USA.
authors.forename: Ranjodh
authors.initials: R
authors.lastname: Gill
authors.affiliation: Spinal Cord Injury and Disorders Center, Hunter Holmes McGuire VAMC, Richmond, Virginia, USA.
authors.forename: Laura C
authors.initials: LC
authors.lastname: O'Brien
authors.affiliation: Spinal Cord Injury and Disorders Center, Hunter Holmes McGuire VAMC, Richmond, Virginia, USA.|Department of Physical Medicine and Rehabilitation, Virginia Commonwealth University, Richmond, Virginia, USA.
authors.forename: Timothy
authors.initials: T
authors.lastname: Lavis
authors.affiliation: Spinal Cord Injury and Disorders Center, Hunter Holmes McGuire VAMC, Richmond, Virginia, USA.
authors.forename: Teodoro
authors.initials: T
authors.lastname: Castillo
authors.affiliation: Spinal Cord Injury and Disorders Center, Hunter Holmes McGuire VAMC, Richmond, Virginia, USA.|Department of Physical Medicine and Rehabilitation, Virginia Commonwealth University, Richmond, Virginia, USA.
authors.forename: David X
authors.initials: DX
authors.lastname: Cifu
authors.affiliation: Surgical Service, Hunter Holmes McGuire VA Medical Center, Richmond, Virginia, USA.
authors.forename: Jeannie
authors.initials: J
authors.lastname: Savas
authors.affiliation: Radiology Service, Hunter Holmes McGuire VA Medical Center, Richmond, Virginia, USA.
authors.forename: Rehan
authors.initials: R
authors.lastname: Khan
authors.affiliation: National Center for the Medical Consequences of Spinal Cord Injury, James J Peters VA Medical Center, Bronx, New York, USA.|Department of Medicine, Icahn School of Medicine at Mt. Sinai, New York City, New York, USA.
authors.forename: Christopher
authors.initials: C
authors.lastname: Cardozo
authors.affiliation: Cardiology Service, Hunter Holmes McGuire VA Medical Center, Richmond, Virginia, USA.|Division of Cardiology, Department of Medicine, Pauley Heart Center Virginia Commonwealth University, Richmond, Virginia, USA.
authors.forename: Edward J
authors.initials: EJ
authors.lastname: Lesnefsky
authors.affiliation: Department of Physical Medicine and Rehabilitation, Penn State Milton S Hershey Medical Center, Hershey, Pennsylvania, USA.
authors.forename: David R
authors.initials: DR
authors.lastname: Gater
authors.affiliation: Endocrinology Service, Hunter Holmes McGuire VA Medical Center, Richmond, Virginia, USA.|Endocrine Division, Virginia Commonwealth University School of Medicine¸ Richmond, Virginia, USA.
authors.forename: Robert A
authors.initials: RA
authors.lastname: Adler
mesh_terms: D000293:Adolescent; D000328:Adult; D000728:Androgens / Q000008:administration & dosage; D001823:Body Composition; D005081:Exercise Therapy / Q000379:methods*; D005260:Female; D005500:Follow-Up Studies; D020249:Hormone Replacement Therapy / Q000379:methods*; D006801:Humans; D008279:Magnetic Resonance Imaging; D008297:Male; D008659:Metabolic Diseases / Q000209:etiology / Q000517:prevention & control*; D055442:Metabolome / Q000502:physiology; D008875:Middle Aged; D018482:Muscle, Skeletal / Q000378:metabolism / Q000503:physiopathology*; D055070:Resistance Training / Q000379:methods*; D013119:Spinal Cord Injuries / Q000150:complications* / Q000175:diagnosis / Q000534:rehabilitation; D013739:Testosterone / Q000008:administration & dosage*; D016896:Treatment Outcome; D055815:Young Adult
chemical_list: D000728:Androgens; D013739:Testosterone
keywords: BODY COMPOSITION and METABOLISM; INFLAMMATORY BIOMARKERS; MITOCHONDRIA; RESISTANCE TRAINING; SPINAL CORD INJURY; TESTOSTERONE