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Improving Function and Metabolism in Spinal Cord Injury

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Multimodality Intervention for Function and Metabolism in SCI

This study is a phase 2, randomized, placebo-controlled, parallel group trial in persons with C7-T12 motor level SCI, AIS grade A, B or C, 6 months or later after injury. The trial will test the hypothesis that a Home-Based Multimodality Functional Recovery and Metabolic Health Enhancement Program that addresses multiple pathophysiologic factors in SCI and includes hybrid exercise (Functional electrical stimulation - leg cycling, FES-LC plus arm ergometry), and an androgen will be more efficacious than hybrid exercise plus placebo in improving aerobic capacity, function, metabolism, and wellbeing.

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Pharmaceutical medication involved common.study.methods.has-drugs-yes
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Drug - Testosterone Undecanoate

administered through injections by study staff

Behavioral - hybrid exercise

hybrid exercise: functional electrical stimulation of lower extremity with leg cycling (FES-LC) and arm ergometry, supervised for two weeks and then home-based

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Effect of a Multimodality Intervention to Improve Function and Metabolism in Spinal Cord Injury

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NCT03576001

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