Division of Geriatrics and Nutritional Science, Washington University School of Medicine in St. Louis, St. Louis, MO, United States of America.
Department of Physical Therapy and Athletic Training, University of Utah, Salt Lake City, UT, United States of America.
Contemp Clin Trials. 2021 May;104:106356. doi: 10.1016/j.cct.2021.106356. Epub 2021 Mar 11.
Up to 75% of hip fracture patients never recover to their pre-fracture functional status. Supervised exercise that includes strength training can improve functional recovery after hip fracture. The role of testosterone replacement for augmenting the effects of exercise in older women after hip fracture is unknown.
The Starting Testosterone and Exercise after Hip Injury (STEP-HI) Study is a 6-month Phase 3 multicenter randomized placebo-controlled trial designed to compare supervised exercise (EX) plus 1% testosterone topical gel, with EX plus placebo gel, and with enhanced usual care (EUC). Female hip fracture patients age ≥ 65 years are being recruited from clinical centers across the United States. Participants are community dwelling and enrolled within 24 weeks after surgical repair of the fracture. The EX intervention is a center-based program of progressive resistance training. The EUC group receives a home exercise program and health education. Participants receive dietary counseling, calcium and vitamin D. The primary outcome is the Six Minute Walk Distance. Secondary outcomes include physical performance measures, self-reported function and quality of life, and dual energy x-ray absorptiometry measures of body composition and bone mineral density.
Enrollment, interventions, and follow-up are ongoing. We describe the impact of the coronavirus disease 2019 pandemic on the trial, including modifications made to allow continuation of the interventions and outcome data collection using remote video and audio technology.
Results from the STEP-HI study are expected to have important clinical and public health implications for management of the growing population of hip fracture patients.
多达 75%的髋部骨折患者从未恢复到骨折前的功能状态。监督下的锻炼，包括力量训练，可以改善髋部骨折后的功能恢复。睾酮替代治疗在增强老年女性髋部骨折后运动效果方面的作用尚不清楚。
启动睾酮和髋部损伤后运动（STEP-HI）研究是一项为期 6 个月的 3 期多中心随机安慰剂对照试验，旨在比较监督下的运动（EX）加 1%睾酮局部凝胶，与 EX 加安慰剂凝胶，以及强化常规护理（EUC）。年龄≥65 岁的女性髋部骨折患者正在从美国各地的临床中心招募。参与者是居住在社区的，并在骨折手术后 24 周内登记。EX 干预措施是一个基于中心的渐进式阻力训练计划。EUC 组接受家庭运动计划和健康教育。参与者接受饮食咨询、钙和维生素 D。主要结果是 6 分钟步行距离。次要结果包括身体表现测量、自我报告的功能和生活质量，以及双能 X 射线吸收法测量身体成分和骨密度。
正在进行入组、干预和随访。我们描述了 2019 年冠状病毒病大流行对试验的影响，包括为允许使用远程视频和音频技术继续进行干预和收集结果数据而进行的修改。
STEP-HI 研究的结果预计将对管理不断增长的髋部骨折患者人群的管理具有重要的临床和公共卫生意义。
