Department of Biomedical Physiology and Kinesiology, Simon Fraser University, 8888 University Drive, Burnaby, British Columbia, V5A 1S6, Canada.
Rehabilitation, Ageing and Independent Living (RAIL) Research Centre, School of Primary and Allied Health Care, Monash University, Peninsula Campus, Building G, Moorooduc Hwy, Frankston, Victoria, 3199, Australia.
Int J Behav Nutr Phys Act. 2023 Mar 24;20(1):34. doi: 10.1186/s12966-023-01431-3.
Toward development of a core outcome set for randomized controlled trials (RCTs) of physical activity (PA) interventions for older adults, the purpose of this study was to identify outcome domains and subdomains ('what' was measured) in previously published RCTs of PA for older adults.
We conducted a rapid review and searched Ovid MEDLINE for recently- published (2015-2021), English-language, RCTs of PA interventions for older adults (mean age 60+ yrs). We limited to articles published in Web of Science top-10 journals in general and internal medicine, geriatrics and gerontology, rehabilitation, and sports science. Two reviewers independently completed eligibility screening; two other reviewers abstracted trial descriptors and study outcomes. We classified study outcomes according to the standard outcome classification taxonomy endorsed by the Core Outcome Measures in Effectiveness Trials Initiative.
Our search yielded 548 articles; 67 articles were eligible to be included. Of these, 82% were efficacy/effectiveness trials, 85% included both male and female participants, and 84% recruited community-dwelling older adults. Forty percent of articles reported on interventions that involved a combination of group and individual PAs, and 60% involved a combination of PA modes (e.g., aerobic, resistance). Trial sample size ranged from 14 to 2157 participants, with median (IQR) of 94 (57-517); 28,649 participants were included across all trials. We identified 21 unique outcome domains, spanning 4/5 possible core areas (physiological/clinical; life impact; resource use; adverse events). The five most commonly reported outcome domains were physical functioning (included in n=51 articles), musculoskeletal and connective tissue (n=30), general (n=26), cognitive functioning (n=16), and emotional functioning/wellbeing (n=14). Under these five outcome domains, we further identified 10 unique outcome subdomains (e.g., fall-related; body composition; quality of life). No outcome domains or subdomains were reported consistently in all RCTs.
We found extensive variability in outcome domains and subdomains used in RCTs of PA for older adults, reflecting the broad range of potential health benefits derived from PA and also investigator interest to monitor a range of safety parameters related to adverse events. This study will inform development of a core outcome set to improve outcome reporting consistency and evidence quality.
为了制定针对老年人身体活动干预的随机对照试验（RCT）的核心结局集，本研究旨在确定先前发表的老年人身体活动 RCT 中测量的结局领域和子领域（“测量了什么”）。
我们进行了快速审查，并在 Ovid MEDLINE 中搜索了最近发表的（2015-2021 年）、英文、针对老年人的身体活动干预 RCT。我们仅限于在综合和内科、老年医学和老年学、康复和运动科学领域的 Web of Science 十大期刊上发表的文章。两位审查员独立完成了资格筛选；另外两位审查员提取了试验描述符和研究结果。我们根据有效性试验核心结局测量倡议认可的标准结局分类分类法对研究结果进行了分类。
我们的搜索产生了 548 篇文章；有 67 篇文章符合纳入标准。其中，82%为疗效/有效性试验，85%纳入了男性和女性参与者，84%招募了社区居住的老年人。40%的文章报道了涉及小组和个人身体活动相结合的干预措施，60%涉及多种身体活动模式（如有氧运动、阻力运动）的干预措施。试验样本量从 14 到 2157 名参与者不等，中位数（IQR）为 94（57-517）；所有试验共纳入 28649 名参与者。我们确定了 21 个独特的结局领域，涵盖了 4/5 个可能的核心领域（生理/临床；生活影响；资源利用；不良事件）。报告最多的五个结局领域是身体功能（51 篇文章中包括）、肌肉骨骼和结缔组织（30 篇）、一般（26 篇）、认知功能（16 篇）和情绪功能/健康（14 篇）。在这五个结局领域下，我们进一步确定了 10 个独特的结局子领域（如与跌倒相关的；身体成分；生活质量）。没有一个结局领域或子领域在所有 RCT 中都得到一致报告。
我们发现，针对老年人身体活动的 RCT 中使用的结局领域和子领域存在广泛的差异，反映了身体活动带来的广泛潜在健康益处，也反映了研究者监测与不良事件相关的一系列安全参数的兴趣。这项研究将为制定核心结局集提供信息，以提高结局报告的一致性和证据质量。
