Department of Physical Medicine and Rehabilitation, Chung-Ang University Hospital, Seoul, Korea.
Department of Biomedical Institute, Chungnam National University, Daejeon, Korea.
BMC Geriatr. 2024 Jan 17;24(1):68. doi: 10.1186/s12877-024-04667-1.
Osteosarcopenia is geriatric syndrome defined as the concomitant occurrence of osteopenia/osteoporosis, and sarcopenia. Osteosarcopenia is a relatively new concept in geriatric medicine; however, it may increase the risk of fragility fractures, several morbidities and mortalities, and socioeconomic costs. Although resistance exercises and nutritional support-including protein, calcium, and vitamin D-are potential non-pharmacological management procedures, evidence is still lacking. The objective of this study was therefore to evaluate the effect of combined resistance exercise and nutritional support on the quality and quantity of bone and muscle in postmenopausal females with osteosarcopenia.
This research proposal presents the protocol for a prospective, single-center, single-blinded, two-armed randomized controlled trial. Thirty-four participants with osteosarcopenia will be recruited and randomly divided into intervention and control groups; both groups will receive nutritional supplements (protein, 40 g; vitamin D, 1600 IU; calcium, 600 mg) daily. The intervention group will undergo 24 weeks of resistance exercise of increasing intensity, achieved through a three-phase step-up process. The primary outcomes will be the changes in skeletal muscle index and bone marrow density of the lumbar spine and femoral neck between the baseline and end of intervention (24 weeks). The secondary outcomes will be the body composition, whole body phase angle, physical function assessment, quality of life, psychological assessment, and bone turnover markers of participants, surveyed at multiple time points.
This randomized controlled trial may reveal the effect of resistance exercise and nutritional support on older postmenopausal women with osteosarcopenia. The results will provide evidence for developing proper non-pharmacological management guidelines for postmenopausal women.
Clinical Research Information Service of Republic of Korea, KCT0008291, Registered on 16 March 2023, https://cris.nih.go.kr/cris/search/detailSearch.do/25262 .
骨质疏松-肌少症是一种老年综合征，定义为骨质疏松/骨量减少和肌少症同时发生。骨质疏松-肌少症是老年医学中的一个相对较新的概念；然而，它可能会增加脆性骨折、多种发病率和死亡率以及社会经济成本的风险。尽管抗阻力运动和营养支持（包括蛋白质、钙和维生素 D）是潜在的非药物治疗方法，但仍缺乏证据。因此，本研究的目的是评估联合抗阻力运动和营养支持对绝经后骨质疏松-肌少症女性骨和肌肉质量和数量的影响。
本研究方案提出了一项前瞻性、单中心、单盲、双臂随机对照试验的研究方案。将招募 34 名骨质疏松-肌少症患者，并将其随机分为干预组和对照组；两组均每日接受营养补充剂（蛋白质 40 g、维生素 D 1600 IU、钙 600 mg）。干预组将接受 24 周的递增强度抗阻力运动，通过三阶段逐步增加的方式进行。主要结局指标是基线和干预结束时（24 周）腰椎和股骨颈的骨骼肌指数和骨髓密度的变化。次要结局指标是参与者的身体成分、全身相位角、身体功能评估、生活质量、心理评估和骨转换标志物，在多个时间点进行调查。
这项随机对照试验可能揭示抗阻力运动和营养支持对老年绝经后骨质疏松-肌少症女性的影响。研究结果将为制定绝经后女性适当的非药物管理指南提供证据。
韩国临床试验注册中心，KCT0008291，于 2023 年 3 月 16 日注册，https://cris.nih.go.kr/cris/search/detailSearch.do/25262 。
