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

BMJ Open, 2017 · DOI: 10.1136/bmjopen-2016-014125 · Published: July 4, 2017

Spinal Cord Injury Endocrinology Neurology

Simple Explanation

Individuals with spinal cord injury (SCI) are at a high risk of obesity and metabolic disorders. This study explores whether testosterone replacement therapy (TRT) combined with resistance training (RT) can improve body composition and metabolic profiles in men with SCI. The study randomly assigns participants to either a RT+TRT group or a TRT-only group. The RT involves using neuromuscular electrical stimulation to help muscles contract during exercise. The primary goal is to investigate how these interventions affect muscle size, fat distribution, and metabolic health, such as glucose and lipid metabolism, in individuals with motor complete SCI.

Study Duration

16 weeks intervention, 16 weeks detraining

Participants

26 men with chronic, motor complete SCI

Evidence Level

Level 1, Randomized Controlled Trial

Key Findings

1
The trial will investigate the use of surface neuromuscular electrical stimulation-induced resistance training (NMES-RT) to restore muscle size after spinal cord injury (SCI).
2
The trial will provide evidence on the effectiveness of testosterone replacement therapy (TRT) to restore muscle size and lean mass and serve as an alternative approach for those who cannot benefit from NMES.
3
The trial will determine how restoring muscle size and lean mass by RT+TRT or TRT can benefit the metabolic profile after SCI.

Research Summary

This study investigates the effects of evoked resistance training (RT) combined with testosterone replacement therapy (TRT) on body composition and metabolic profiles in men with chronic, motor complete spinal cord injury (SCI). The study involves a randomized controlled trial where participants are assigned to either a RT+TRT group or a TRT-only group for 16 weeks, with a subsequent detraining phase to assess the maintenance of benefits. The primary outcomes focus on changes in muscle cross-sectional area (CSA), visceral adipose tissue (VAT), and percentage of fat mass (%FM), while secondary outcomes assess glucose and lipid metabolism.

Practical Implications

Exercise Therapies Design

Findings 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.

TRT as Alternative Intervention

TRT alone may provide an alternative intervention for those who cannot benefit from training using surface NMES.

Insights into Molecular Pathways

The study will also shed light on several molecular pathways that have been suggested to influence body composition and metabolic profile.

Study Limitations

1
The study is only limited to men with complete SCI.
2
Surface NMES may not benefit those with full sensation or lower motor neuron denervation.
3
The current study was limited to those who were ≤50 years old.

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