Effect of a Multimodality Intervention to Improve Function and Metabolism in Spinal Cord Injury
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 84
- 试验地点
- 1
- 主要终点
- Change From Baseline in VO2 Peak (L/Min) Achieved During Arm Ergometry Exercise Alone
研究概览
简要总结
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.
详细描述
Study Description: 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.
Objectives:
Primary Objective:
• To determine whether the multimodality intervention is more efficacious in improving peak aerobic capacity, and muscle mass and strength than placebo plus functional electrical stimulation during leg cycling (FES-LC) plus arm ergometry alone.
Secondary Objectives:
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 19 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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.
排除标准
- •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:
- •History of prostate or breast cancer
- •Prostate nodule or induration on digital rectal examination (DRE)
- •Prostate specific antigen (PSA) > 4 ng/ml or > 3 ng/ml in individuals at high risk of prostate cancer such as African Americans or those with family history of prostate cancer in first degree relatives, unless there has been a negative prostate biopsy within 3 months
- •Hematocrit > 48%
- •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
- •Psychosis, bipolar disorder, or major untreated depression
- •Dementia (Mini-Mental Status Exam [MMSE] <24)
- •Myocardial infarction (MI) or stroke within 3 months of entry
- •ALT and AST > 3 x upper limit of normal
- •Poorly controlled diabetes as indicated by hemoglobin (Hb)-A1c greater than 9.0% or diabetes requiring insulin therapy
- •Blood thinners such as Coumadin, heparin, rivaroxaban (Xarelto), dabigatran (Pradaxa), lovenox (subcutaneous heparin), apixaban (Eliquis) (aspirin, plavix and other anti-platelet agents are allowed)
- •Systolic blood pressure (BP) > 170 or diastolic BP > 100 mm Hg
- •Current grade 2 or greater pressure ulcers at relevant contact sites
- •Pressure sores or open wounds on the areas that restricts their participation
- •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. We will perform a blood test to exclude pregnancy at the time of enrollment.
- •Participation in a structured exercise program currently or in the past 2 months and unwilling to stop the structured exercise program if ongoing at time of screening. Specifically, participation in a structured exercise program, currently or in the past 2 months, that involves progressive resistance exercise training of moderate to high intensity or regular endurance exercise of moderate to high intensity, and unwillingness to stop the structured exercise program if ongoing at time of screening.
- •Inability or unwillingness to participate in the exercise training or the assessments of muscle performance and physical performance
研究组 & 干预措施
Multi-modality intervention group
Hybrid exercise (functional electrical stimulation - leg cycling, FES LC plus arm ergometry) plus Testosterone undecanoate
干预措施: hybrid exercise (Behavioral)
Placebo group
Hybrid exercise plus placebo medication
干预措施: hybrid exercise (Behavioral)
Multi-modality intervention group
Hybrid exercise (functional electrical stimulation - leg cycling, FES LC plus arm ergometry) plus Testosterone undecanoate
干预措施: Testosterone Undecanoate (Drug)
结局指标
主要结局
Change From Baseline in VO2 Peak (L/Min) Achieved During Arm Ergometry Exercise Alone
时间窗: Week 16
Week 16 change from baseline in VO2 peak aerobic capacity during cardiopulmonary testing using arm ergometry exercise alone
Change From Baseline in VO2 Peak (mL/kg/Min) Achieved During Arm Ergometry Exercise Alone
时间窗: Week 16
Week 16 change from baseline in VO2 peak aerobic capacity during cardiopulmonary testing using arm ergometry exercise alone
次要结局
- Change From Baseline in VO2 Peak (L/Min) Achieved During FES-LC Exercise Alone(Week 16)
- Change From Baseline in Fasting Glucose(Week 16)
- Change From Baseline in Triglycerides(Week 16)
- Change From Baseline in VO2 Peak (mL/kg/Min) Achieved During FES-LC Exercise Alone(Week 16)
- Change From Baseline in VO2 Peak (L/Min) Achieved During Combined FES-LC and AE Exercise(Week 16)
- Change From Baseline in VO2 Peak (mL/kg/Min) Achieved During Combined FES-LC and AE Exercise(Week 16)
- Change From Baseline in Work Rate Max During Arm Ergometry Alone(Week 16)
- Change From Baseline in Work Rate Max During FES-LC Exercise Alone(Week 16)
- Change From Baseline in Work Rate Max During Combined FES-LC + AE Exercise(Week 16)
- Change From Baseline in the One Repetition Maximum (1-RM) Voluntary Strength in the Chest Press Exercise(Week 16)
- Change From Baseline in the Muscle Endurance in the Chest Press Exercise(Week 16)
- Change From Baseline in Hemoglobin A1C(Week 16)
- Change From Baseline in the Whole Body Lean Mass Measured Using Dual Energy X-ray Absorptiometry (DXA)(Week 16)
- Change From Baseline in the Upper Extremity Lean Tissue Mass Measured Using DXA(Week 16)
- Change From Baseline in the Lower Extremity Lean Tissue Mass Measured Using DXA(Week 16)
- Change From Baseline in the Trunk Lean Tissue Mass Measured Using DXA(Week 16)
- Change From Baseline in the Appendicular Lean Tissue Mass Measured Using DXA(Week 16)
- Change From Baseline Homeostatic Model Assessment for Insulin Resistance(16 weeks)
- Change From Baseline in Total Cholesterol(Week 16)
- Change From Baseline in Low-density Lipoprotein(Week 16)
- Change From Baseline in Non-HDL Cholesterol(Week 16)
- Change From Baseline in HDL Cholesterol(Week 16)
- Change From Baseline in Inflammatory Markers(Week 16)
- Change From Baseline in Self-reported Function and Mobility (SCI-FI) (Basic Mobility Standardized Score: 31.97 - 68.48), With a Higher Score Indicating Better Mobility(Week 16)
- Change From Baseline in Depressive Symptoms, Ascertained Using the Patient Health Questionnaire - 9 (PHQ-9) (Score: 0-27), With a Higher Score Indicating More Severe Depression(Week 16)
- Change From Baseline in Pain and Its Impact on Life, Ascertained Using the Brief Pain Inventory (BPI) (Score:0 - 10), With a Higher Score Indicating More Pain(Week 16)
- Change From Baseline in Loneliness, Using a 3-item Loneliness Questionnaire (Score: 3-9), With a Higher Score Indicating More Loneliness(Week 16)
- Change From Baseline in Satisfaction With Life, Ascertained Using the Satisfaction With Life Scale (SWLS) (Score: 5 - 35), With a Higher Score Indicating More Satisfaction With Life(Week 16)
- Change From Baseline in Anxiety Ascertained Using the Generalized Anxiety Disorder - 7 Scale (GAD-7) (Score: 0 - 21), With a Higher Score Indicating Worse Anxiety(Week 16)
研究者
Shalendar Bhasin, MD
Professor
Brigham and Women's Hospital