Combining Testosterone Therapy and Exercise to Improve Function Post Hip Fracture

结合睾酮治疗和运动来改善髋部骨折后的功能

基本信息

批准号：
9174730
负责人：
ELLEN F BINDER
金额：
$ 269.7万
依托单位：
WASHINGTON UNIVERSITY
依托单位国家：
美国
项目类别：
财政年份：
2017
资助国家：
美国
起止时间：
2017-09-15 至 2022-05-31
项目状态：
已结题

来源：
https://reporter.nih.gov/project-details/9174730
关键词：
Activities of Daily Living Adherence Adverse event Age Androgens Award Biochemical Blinded Bone Density Caring Clinical Clinical Trials Cooperative Group Contralateral Double-Blind Method Dual-Energy X-Ray Absorptiometry Elderly Enrollment Event Exercise Failure Female Femur Fracture Frail Elderly Gait speed Goals Grant Health Care Costs Hip Fractures Hip region structure Impairment Individual Intervention Leg Limb structure Manuals Measurement Measures Mission Monitor Morbidity - disease rate Outcome Measure Patient Self-Report Patients Performance Pharmaceutical Preparations Phase Physical Function Physical Performance Pilot Projects Placebo Control Placebos Population Procedures Protocols documentation Public Health Quality of life Questionnaires Randomized Recruitment Activity Reporting Risk Factors SF-36 Serum Site Skeletal Muscle Supervision Supplementation Testing Testosterone Walking Woman active method clinical research site design exercise training frailty functional decline functional disability functional status improved improved functioning lean body mass mortality multidisciplinary muscle form muscle strength older women patient population performance tests post intervention primary outcome screening secondary outcome virtual

项目摘要

Hip fractures are common among older women and can have a devastating impact on their ability to remain independent. A clinically important functional decline and failure to recover following a hip fracture has been documented as much as a year after the fracture, even among individuals who were functioning at high levels before the event. Age-associated androgen deficiency in women contributes to deficits in muscle mass, strength and power that are common in this patient population before the fracture, and are exacerbated afterward. A pilot study of testosterone (T) supplementation in elderly female hip fracture patients has demonstrated the feasibility of T treatment in this population, and showed gains in lean body mass (LBM) and muscle strength with active drug, compared to placebo. The benefits of exercise in restoring muscle strength and physical function after a hip fracture have been documented. However, it remains unclear whether T treatment can augment the effects of exercise on mobility and patient-reported function, or whether any observed benefits are sustained beyond the period of active treatment. Proposed is a 3-group, multi-center, randomized, placebo-controlled, double-blinded, parallel group clinical trial in frail elderly female hip fracture patients. 300 female hip fracture patients will be enrolled from 6 clinical sites, using objective screening criteria for T deficiency (serum total testosterone level < 30 ng/dl) and physical frailty (Modified Physical Performance Test (PPT) Score < 28). The trial will compare the effects of supervised exercise training (EX) alone, EX combined with T therapy (EX+T) and no EX with placebo T treatment (CON), to ascertain the incremental impact of adding T to ET in older adult women following hip fracture. The 6-month intervention will be followed by a 6-month no-treatment sustainability phase. The primary outcome measure is the Six Minute Walk Distance (6MWD). Secondary outcome measures include: 1) dual energy x-ray absorptiometry (DXA) measurements of whole body and appendicular LBM and bone mineral density of the unfractured proximal femur; 2) maximal skeletal muscle strength (1-RM) for leg extension in both limbs; 3) objective physical performance measures; and 4) self-reported performance of activities of daily living and quality of life, including the Hip Rating Questionnaire (HRQ). We plan to carefully monitor testosterone levels, adverse events, biochemical parameters, and factors related to adherence to the interventions. Information from this study has the potential to alter treatment of hip fracture in older women, a problem that contributes to significant morbidity and mortality, and has a large public health impact. The proposed study is highly aligned with NIA’s mission of identifying interventions that target common geriatric conditions, and improve treatment options for older adults with multiple morbidities or risk factors.

髋部骨折在老年妇女中很常见，可能对其能力产生毁灭性的影响保持独立。髋部骨折后临床上重要的功能下降和无法恢复的恢复被记录在裂缝后一年后，即使在高度运作的人中活动开始前的水平。女性与年龄相关的雄激素缺乏症有助于定义肌肉质量，骨折之前该患者人群中常见的力量和力量，并且会加重之后。雌性髋部骨折患者补充睾丸激素（T）的试点研究证明了T治疗在该人群中的可行性，并显示出瘦体重（LBM）和与安慰剂相比，用活跃药物的肌肉力量。运动在恢复肌肉力量方面的好处髋部骨折后的身体功能已记录在记录中。但是，尚不清楚是否t 治疗可以增加运动对移动性和患者报告功能的影响，或者是否有任何观察到的益处超出了主动治疗期。提议的是3组，多中心弱雌性髋部骨折的随机，安慰剂对照，双盲，平行组临床试验患者。 300名女性髋部骨折患者将使用客观筛查标准从6个临床部位招募缺乏症（血清总睾丸激素水平<30 ng/dl）和身体脆弱（修改的身体表现测试（PPT）得分<28）。该试验将比较受监督运动训练（EX）的影响，Ex 与T疗法（EX+T）结合使用，没有安慰剂T治疗（CON），以确定增量髋部骨折后，将T增加到ET的影响。将遵循6个月的干预措施在6个月的无治疗可持续性阶段。主要结果措施是步行六分钟距离（6MWD）。次要结果措施包括：1）双能X射线绝对肽仪（DXA）全身和阑尾LBM的测量以及未分裂近端的骨矿物质密度股骨2）两个四肢的腿部伸展的最大骨骼肌强度（1-RM）； 3）客观物理绩效指标； 4）自我报告的日常生活活动和生活质量的活动，包括髋关节评级问卷（HRQ）。我们计划仔细监视睾丸激素水平，不良事件，生化参数以及与干预措施遵守有关的因素。这项研究的信息有可能改变老年妇女的髋部骨折治疗，这是一个问题这有助于大量的发病率和死亡率，并对公共卫生产生巨大影响。提议研究与NIA的使命高度一致，该任务是识别针对常见老年病情的干预措施，并改善具有多种病毒或危险因素的老年人的治疗选择。