Friedman Ben, Beamer Brock A, Beans Jeffrey, Gray Vicki, Alon Gad, Ryan Alice, Katzel Leslie I, Sorkin John D, Addison Odessa
Department of Physical Therapy and Rehabilitation Science, School of Medicine, University of Maryland, Baltimore, Baltimore, MD, United States.
Baltimore Geriatric Research, Education, and Clinical Center, VA Maryland Health Care System, Baltimore, MD, United States.
JMIR Res Protoc. 2025 May 1;14:e68082. doi: 10.2196/68082.
Nearly half of all veterans are 65 years and older, and they have a higher prevalence of functional disabilities compared to the nonveteran population. Balance impairments resulting in injurious falls are a leading cause of morbidity and mortality in older adults. Instability or fear of falling can significantly reduce physical activity and social participation, even in the absence of falls. Dysmobility is a leading factor in long-care admissions, and therefore, maintenance of mobility throughout aging is crucial. Recent evidence indicates lower extremity muscle weakness as a key risk factor for falls, with lower limb muscle strength and quality being critical for balance recovery. The primary hip abductors, the gluteus maximus, medius, and minimus, are particularly essential for balance recovery.
This study aims to test the hypothesis that adding neuromuscular electrical stimulation (NMES) to a multimodality balance intervention (MMBI) will yield greater reductions in fall risk and improvements in muscle and mobility function compared with MMBI alone.
This randomized controlled trial will enroll 80 veterans aged 55 years and older at risk for falls (defined by a four-square step test [FSST] time >12 seconds, history of falls, or fear of falling). Participants will be randomized to receive either NMES + MMBI or MMBI alone. The 12-week outpatient center-based intervention will include 3 sessions per week, focusing on hip abductor strength, balance, and mobility. Assessments will occur at baseline, postintervention, and at 6- and 12-month follow-ups. Primary outcomes include fall risk and dynamic balance, measured by FSST and hip abductor strength using a Biodex dynamometer. Secondary outcomes will examine muscle composition through computed tomography (CT) scans and assess gait variability parameters.
This study was funded on January 1, 2022, with a data collection period from April 1, 2022, to December 31, 2026. As of March 2025, we have screened 100 potential participants and excluded 38. Out of the 61 participants enrolled to date, 21 have completed the 12-month follow-up, 32 have completed the 6-month follow-up, and 41 have completed the posttesting. A total of 4 participants are currently in the intervention phase; 1 has just completed the baseline testing, while 15 have been dropped from the study.
This trial will be the first large, randomized controlled trial to evaluate NMES as an adjunct to an MMBI for fall prevention in older veterans. If successful, NMES combined with hip abductor strengthening and balance training could provide a low-cost, scalable solution to reduce falls, improve balance and mobility, and decrease health care costs related to falls in older adults. This study will address a critical gap in knowledge about the effectiveness of NMES in enhancing rehabilitation outcomes for fall prevention.
ClinicalTrials.gov NCT04969094; https://clinicaltrials.gov/study/NCT04969094.
INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): DERR1-10.2196/68082.
近一半的退伍军人年龄在65岁及以上,与非退伍军人相比,他们功能残疾的患病率更高。导致受伤跌倒的平衡障碍是老年人发病和死亡的主要原因。即使在没有跌倒的情况下,身体不稳定或害怕跌倒也会显著减少身体活动和社会参与。行动不便是非长期护理机构住院的主要因素,因此,在整个衰老过程中保持行动能力至关重要。最近的证据表明,下肢肌肉无力是跌倒的关键风险因素,下肢肌肉力量和质量对于平衡恢复至关重要。主要的髋关节外展肌,即臀大肌、臀中肌和臀小肌对于平衡恢复尤为重要。
本研究旨在检验以下假设:与单独的多模式平衡干预(MMBI)相比,在多模式平衡干预中添加神经肌肉电刺激(NMES)将更大程度地降低跌倒风险,并改善肌肉和运动功能。
这项随机对照试验将招募80名55岁及以上有跌倒风险的退伍军人(通过四方步测试[FSST]时间>12秒、跌倒史或害怕跌倒来定义)。参与者将被随机分配接受NMES+MMBI或单独的MMBI。为期12周的门诊中心干预将包括每周3次课程,重点是髋关节外展肌力量、平衡和运动能力。评估将在基线、干预后以及6个月和12个月随访时进行。主要结局包括跌倒风险和动态平衡,通过FSST和使用Biodex测力计测量的髋关节外展肌力量来衡量。次要结局将通过计算机断层扫描(CT)扫描检查肌肉组成,并评估步态变异性参数。
本研究于2022年1月1日获得资助,数据收集期为2022年4月1日至2026年12月31日。截至2025年3月,我们已经筛选了100名潜在参与者,排除了38名。在迄今招募的61名参与者中,21名完成了12个月随访,32名完成了6个月随访,41名完成了干预后测试。目前共有4名参与者处于干预阶段;1名刚刚完成基线测试,而15名已退出研究。
这项试验将是第一项大型随机对照试验,以评估NMES作为MMBI的辅助手段用于预防老年退伍军人跌倒的效果。如果成功,NMES与髋关节外展肌强化和平衡训练相结合可以提供一种低成本、可扩展的解决方案,以减少跌倒、改善平衡和运动能力,并降低与老年人跌倒相关的医疗保健成本。本研究将填补关于NMES在增强预防跌倒康复效果方面有效性的关键知识空白。
ClinicalTrials.gov NCT04969094;https://clinicaltrials.gov/study/NCT04969094。
国际注册报告识别码(IRRID):DERR1-10.2196/68082。