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PubMed · 41988780

Effects of testosterone-augmented multimodal exercise intervention in spinal cord injury: a randomized controlled trial.

Kieran F Reid·Thomas W Storer·Karol M Pencina·Catherine Ghattas·Yili V Shang·Connor Gavin·Rodrigo J Valderrábano·Nancy K Latham·Eric M Bracken·Lauren Lemay·Mohan S Chandra·Sarah E Skeels·Yashi Singh·Nicole Bajdek·Alexander P Lin·Ross D Zafonte·Shalender Bhasin
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Abstract

CONTEXT: Spinal cord injury (SCI) leads to profound muscle atrophy, aerobic deconditioning, and metabolic dysfunction. Exercise-based interventions alone produce modest benefits. Whether testosterone can augment physiologic responses to exercise in this population remains untested. OBJECTIVE: To evaluate efficacy and safety of home-based intervention combining functional electrical stimulation-assisted leg cycling (FES-LC), arm ergometry (AE), and testosterone compared with FES-LC, AE plus placebo in adults with SCI. METHODS: This randomized, placebo-controlled, double-blind trial enrolled 84 adults (76 males and 8 females) aged 19-70 years with SCI (neurologic levels C4-T12; AIS grades A-D). Participants were randomized to multimodality intervention (home-based FES-LC, AE and intramuscular testosterone undecanoate) (n = 38) or control intervention (FES-LC, AE plus placebo) (n = 46) for 16 weeks. The primary outcome was change in aerobic capacity (peak VO2) during AE cardiopulmonary exercise testing. Secondary outcomes included lean mass, hemoglobin, cardiometabolic markers, and safety. RESULTS: Mean (SD) age was 44 (13) years and time since injury was 13.9 (13) years). Between-group changes in peak VO2 were not statistically significant. Within-group improvements were larger in multimodality (∼19% increase; 0.10 L/min; 95% CI, 0.02-0.18 L/min) compared to controls (∼6% increase; 0.06 L/min; 95% CI, -0.01-0.13). The multimodality group gained significantly more lean mass (whole-body:1.84 kg, 95% CI: 0.52-3.16, P = .007; lower extremity 0.92 kg, 95% CI: 0.38-1.45, P = .001), and anemia was corrected in a greater proportion of participants. Adverse event rates were similar between groups. CONCLUSION: A home-based multimodality intervention combining FES-LC, AE, and testosterone was safe and associated with greater improvements in lean mass and hemoglobin. Although between-group differences in aerobic capacity were not statistically significant, greater within-group increases were observed in the multimodality group. These findings may inform future studies of testosterone-augmented exercise interventions for individuals living with SCI.

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HumansSpinal Cord InjuriesMaleAdultTestosteroneMiddle AgedFemaleExercise TherapyAgedDouble-Blind MethodCombined Modality TherapyElectric Stimulation TherapyYoung AdultExercise TestTreatment Outcomeaerobic capacitycardiopulmonary exercise testingexercise trainingfunctional electrical stimulationlean body massmultimodality interventionspinal cord injurytestosterone therapyJournal ArticleRandomized Controlled Trial

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Kieran F Reid, Thomas W Storer, Karol M Pencina, Catherine Ghattas, Yili V Shang, Connor Gavin, Rodrigo J Valderrábano, Nancy K Latham, Eric M Bracken, Lauren Lemay, Mohan S Chandra, Sarah E Skeels, Yashi Singh, Nicole Bajdek, Alexander P Lin, Ross D Zafonte, Shalender Bhasin. 2026-09-16. Effects of testosterone-augmented multimodal exercise intervention in spinal cord injury: a randomized controlled trial.. https://doi.org/10.1210/clinem/dgag173

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Journal Article; Randomized Controlled Trial resourceAdult subjectAged subjectCombined Modality Therapy subjectDouble-Blind Method subjectExercise Therapy subjectExercise training subjectFemale subjectHumans subjectJournal Article subjectMale subjectMiddle Aged subjectRandomized controlled trials study

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