Table 1 Study inclusion and exclusion criteria
Inclusion Criteria | |
  1. Men and women, 19 to 70 years | |
  2. Confirmed cervical and thoracic, AIS A-D who are at least 6 months post-injury | |
  3. Uses a wheelchair as their primary mobility mode | |
  4. Medically stable, able to follow directions | |
  5. Able to provide informed consent | |
  6. For females of reproductive potential who are sexually active: use of highly effective contraception for at least 1 month prior to Day 1 and agreement to use such a method during study participation and for an additional 12 weeks after the end of intervention | |
Exclusion Criteria | |
  1. Upper extremity musculoskeletal conditions (such as advanced rotator cuff pathology or carpal tunnel syndrome) or neurological disorder that would prevent the participant from performing the prescribed arm ergometry | |
  2. Current fractures in the upper and lower extremity | |
  3. Individuals with a contraindication for androgen (in accordance with the Endocrine Society and ISSAM Guidelines) | |
  4. Conditions that would render exercise and FES unsafe or unfeasible such as severe autonomic dysreflexia, severe pressure sores, severe spasticity and severe pain | |
  5. Body mass index (BMI) > 45 kg/m2 | |
  6. Renal dysfunction as indicated by GFR of < 50 ml/min | |
  7. Use of testosterone or other anabolic therapies, including DHEA and androstenedione, or rhGH in the preceding 6 months | |
  8. Active cancer requiring therapy and which may limit life expectancy to less than 5 years | |
  9. Psychosis, bipolar disorder, or major untreated depression | |
  10. Dementia (Mini-Mental Status Exam [MMSE] < 24) | |
  11. Myocardial infarction (MI) or stroke within 3 months of entry | |
  12. Pacemaker | |
  13. ALT and AST > 3 x upper limit of normal | |
  14. Poorly controlled diabetes as indicated by hemoglobin (Hb)-A1c greater than 9.0% or diabetes requiring insulin therapy | |
  15. Blood thinners such as Coumadin, heparin, rivaroxaban (Xarelto), dabigatran (Pradaxa), lovenox (subcutaneous heparin), apixaban (Eliquis) (aspirin, plavix and other anti-platelet agents are allowed) | |
  16. Systolic blood pressure (BP) > 170 or diastolic BP > 100 mmHg | |
  17. Current grade 2 or greater pressure ulcers at relevant contact sites | |
  18. Pressure sores or open wounds on the areas that restricts their participation | |
  19. Because the safety of testosterone has not been established in pregnancy and lactation, we will exclude pregnant or lactating women and women of childbearing potential who are sexually active but are unwilling or unable to use a reliable form of contraception. | |
  20. Participation in a structured exercise program currently or in the past 2 months |