Multimodality Intervention for Function and Metabolism in SCI
- Conditions
- Spinal Cord Injuries
- Registration Number
- NCT03576001
- Lead Sponsor
- Brigham and Women's Hospital
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- 84
INCLUSION CRITERIA<br><br> 1. Men and women, 19 to 70 years<br><br> 2. Confirmed cervical and thoracic, AIS A-D who are at least 6 months post-injury and<br> who use a wheelchair as their primary mobility mode<br><br> 3. Medically stable, able to follow directions<br><br> 4. Able to provide informed consent.<br><br> 5. For females of reproductive potential who are sexually active: use of highly<br> effective contraception for at least 1 month prior to Day 1 and agreement to use<br> such a method during study participation and for an additional 12 weeks after the<br> end of intervention.<br><br>EXCLUSION CRITERIA<br><br> 1. Upper extremity musculoskeletal conditions (such as advanced rotator cuff pathology<br> or carpal tunnel syndrome) or neurological disorder that in the assessment of the<br> study investigator would prevent the participant from performing the prescribed arm<br> ergometry.<br><br> 2. Current fractures in the upper and lower extremity<br><br> 3. In accordance with the Endocrine Society and ISSAM Guidelines25,52, we will exclude<br> individuals with a contraindication for androgen use:<br><br> - History of prostate or breast cancer<br><br> - Prostate nodule or induration on digital rectal examination (DRE)<br><br> - Prostate specific antigen (PSA) > 4 ng/ml or > 3 ng/ml in individuals at high<br> risk of prostate cancer such as African Americans or those with family history<br> of prostate cancer in first degree relatives, unless there has been a negative<br> prostate biopsy within 3 months<br><br> - Hematocrit > 48%<br><br> 4. Conditions that would render exercise and FES unsafe or unfeasible such as severe<br> autonomic dysreflexia, severe pressure sores, severe spasticity and severe pain.<br><br> 5. Body mass index (BMI) > 45 kg/m2<br><br> 6. Renal dysfunction as indicated by GFR of <50 ml/min, estimated by using the<br> Modification of Diet in Kidney Disease (MDRD) Study equation, in accordance with<br> K/DOQI guidelines<br><br> 7. Use of testosterone or other anabolic therapies, including DHEA and androstenedione,<br> or rhGH in the preceding 6 months<br><br> 8. Active cancer requiring therapy and which may limit life expectancy to less than 5<br> years<br><br> 9. Psychosis, bipolar disorder, or major untreated depression<br><br> 10. Dementia (Mini-Mental Status Exam [MMSE] <24)<br><br> 11. Myocardial infarction (MI) or stroke within 3 months of entry<br><br> 12. Pacemaker<br><br> 13. ALT and AST > 3 x upper limit of normal<br><br> 14. Poorly controlled diabetes as indicated by hemoglobin (Hb)-A1c greater than 9.0% or<br> diabetes requiring insulin therapy<br><br> 15. Blood thinners such as Coumadin, heparin, rivaroxaban (Xarelto), dabigatran<br> (Pradaxa), lovenox (subcutaneous heparin), apixaban (Eliquis) (aspirin, plavix and<br> other anti-platelet agents are allowed)<br><br> 16. Systolic blood pressure (BP) > 170 or diastolic BP > 100 mm Hg<br><br> 17. Current grade 2 or greater pressure ulcers at relevant contact sites<br><br> 18. Pressure sores or open wounds on the areas that restricts their participation<br><br> 19. Because the safety of testosterone has not been established in pregnancy and<br> lactation, we will exclude pregnant or lactating women and women of childbearing<br> potential who are sexually active but are unwilling or unable to use a reliable form<br> of contraception. We will perform a blood test to exclude pregnancy at the time of<br> enrollment.<br><br> 20. Participation in a structured exercise program currently or in the past 2 months and<br> unwilling to stop the structured exercise program if ongoing at time of screening.<br> Specifically, participation in a structured exercise program, currently or in the<br> past 2 months, that involves progressive resistance exercise training of moderate to<br> high intensity or regular endurance exercise of moderate to high intensity, and<br> unwillingness to stop the structured exercise program if ongoing at time of<br> screening.<br><br> 21. Inability or unwillingness to participate in the exercise training or the<br> assessments of muscle performance and physical performance
Not provided
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method peak aerobic capacity
- Secondary Outcome Measures
Name Time Method whole body skeletal muscle and fat mass;maximal voluntary strength and muscle fatigability in upper extremity;metabolism measures;Spinal Cord Injury Function Index Computer Adaptive Test (SCI-FI CAT);Mood;Anxiety;Satisfaction with Life;Safety Assessment;Loneliness