Multimodality Intervention for Function and Metabolism in SCI (NCT03576001) | Clinical Trial Compass
CompletedPhase 2
Multimodality Intervention for Function and Metabolism in SCI
United States84 participantsStarted 2019-08-23
Plain-language summary
The proposed phase 2 trial a randomized, placebo-controlled, parallel group trial in persons with cervical or thoracic SCI, AIS grade A, B, C, or D, 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 functional electrical stimulation during leg cycling (FES-LC) plus arm ergometry and an androgen will be more efficacious than functional electrical stimulation during leg cycling (FES-LC) plus arm ergometry plus placebo in improving aerobic capacity, function, metabolism, bone health, and wellbeing.
Who can participate
Age range19 Years – 70 Years
SexALL
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Inclusion criteria
✓. Men and women, 19 to 70 years
✓. Confirmed cervical and thoracic, AIS A-D who are at least 6 months post-injury and who use a wheelchair as their primary mobility mode
✓. Medically stable, able to follow directions
✓. Able to provide informed consent.
✓. 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
✕. Upper extremity musculoskeletal conditions (such as advanced rotator cuff pathology or carpal tunnel syndrome) or neurological disorder that in the assessment of the study investigator would prevent the participant from performing the prescribed arm ergometry.
✕. Current fractures in the upper and lower extremity
✕. In accordance with the Endocrine Society and ISSAM Guidelines25,52, we will exclude individuals with a contraindication for androgen use:
What they're measuring
1
Change From Baseline in VO2 Peak (L/Min) Achieved During Arm Ergometry Exercise Alone
Timeframe: Week 16
2
Change From Baseline in VO2 Peak (mL/kg/Min) Achieved During Arm Ergometry Exercise Alone
✕. Conditions that would render exercise and FES unsafe or unfeasible such as severe autonomic dysreflexia, severe pressure sores, severe spasticity and severe pain.
✕. Body mass index (BMI) \> 45 kg/m2
✕. Renal dysfunction as indicated by GFR of \<50 ml/min, estimated by using the Modification of Diet in Kidney Disease (MDRD) Study equation, in accordance with K/DOQI guidelines
✕. Use of testosterone or other anabolic therapies, including DHEA and androstenedione, or rhGH in the preceding 6 months
✕. Active cancer requiring therapy and which may limit life expectancy to less than 5 years