Effects of Testosterone and Evoked Resistance Exercise after Spinal Cord Injury (TEREX-SCI): study protocol for a randomised controlled trial

Abstract

IntroductionIndividuals 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.Methods and analysis26 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.Ethics and disseminationThe 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.Trial registration numberPre-result, NCT01652040.

A feasibility pilot using telehealth videoconference monitoring of home-based NMES resistance training in persons with spinal cord injury

“…Participants with experience in the application of NMES-RT (n = 11) from the parent trial were approached to participate in the current trial. 15 Five participants were accepted on the basis of first-come-first-serve to participate in an optional 8-week telehealth continuation in a homebased setting. The washout period was designed to eliminate the training effect of participating in the parent clinical trial.…”

Liver Adiposity and Metabolic Profile in Individuals with Chronic Spinal Cord Injury

“…Written informed consent was obtained from each participant as part of a clinical trial ( NCT01652040 ). Data presented was obtained at baseline, prior to the intervention, and the study protocol has been published separately [ 41 ].…”

“…Metabolic profile was assessed as previously described [ 41 , 42 ]. Blood samples were taken every 2 minutes before and 2-3 minutes after glucose injection (0.3 g/kg) for 30 minutes, followed by sampling every 5, 10, 20, and 30 minutes ending at 180 minutes.…”

“…The study criteria excluded individuals with uncontrolled diabetes or known cardiovascular disease [ 41 ]. Because the study intervention included testosterone replacement therapy, only men were included.…”

Anthropometric Prediction of Visceral Adipose Tissue in Persons With Motor Complete Spinal Cord Injury

“…Twenty‐two men with motor complete SCI (14 with paraplegia and 8 with tetraplegia) were recruited as a part of a clinical trial ctgov:NCT01652040 [28]. Participants' characteristics are presented in Table 1.…”