Testing Interventions for Mobility through Exercise (TIME): Study protocol for a randomized trial comparing a novel, brief home-based exercise program and a standard home-based group exercise for older adults with mobility disability

IF 2 3区 医学 Q3 MEDICINE, RESEARCH & EXPERIMENTAL
Christopher N. Sciamanna , Jordan D. Kurth , William Luzier , David E. Conroy , Willam A. Calo , Kathryn Schmitz , Matthew L. Silvis , Noel H. Ballentine , Shouhao Zhou , Margaret Danilovich , Liza S. Rovniak , Matthew Moeller , Natalia Pierwola-Gawin , Jennifer L. Kraschnewski , Jennifer Poger , Cheyenne Herrell
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Abstract

One in four older adults report difficulty walking, greatly increasing the risk of future disability and death. Though exercise improves mobility, too few older adults do it. While studies show that brief exercise sessions provide most of the benefit of longer sessions and that older adults note that “time” is a critical barrier to being active, what remains unknown is whether briefer RT sessions can improve mobility as well as, or better than, longer traditional sessions, possibly due to greater adherence. We present the design of a 12-month randomized controlled trial of 700 older adults with self-reported walking difficulty. Participants will be randomly assigned, in a 2 × 2 factorial design, to one of two home-based exercise programs: 1) Standard of Care: 45-min, three-times weekly sessions or 2) Experimental: 5-min daily sessions and to one of two doses of behavior change techniques (Standard or Enhanced) as part of their exercise program. The primary outcome measure is self-reported physical function. Secondary outcome measures include objectively measured lower extremity physical performance, walking endurance, balance, walking speed, strength and physical activity as well as self-reported falls, pain, fatigue and balance. This is one of the first studies to examine the clinical outcomes of brief exercise sessions, which may lead to a new generation of exercise programs that are optimized not only for impact, but for adherence as well.
测试通过运动提高行动能力的干预措施(TIME):针对行动不便的老年人,比较新颖、简短的家庭锻炼计划和标准的家庭集体锻炼的随机试验研究方案。
每四位老年人中就有一位表示行走困难,这大大增加了未来残疾和死亡的风险。虽然运动能提高行动能力,但做运动的老年人太少了。虽然研究表明,简短的运动疗程能提供较长时间疗程的大部分益处,而且老年人也指出 "时间 "是阻碍他们积极锻炼的关键因素,但仍不清楚的是,较简短的 RT 疗程是否能像传统的较长时间疗程一样改善行动能力,甚至比后者更好,这可能是由于坚持的程度更高。我们介绍了一项为期 12 个月的随机对照试验的设计方案,试验对象是 700 名自称行走困难的老年人。参与者将以 2 × 2 的因子设计被随机分配到两种家庭锻炼计划中的一种:1)标准护理计划:每周三次,每次 45 分钟;或 2)实验计划:每天一次,每次 5 分钟。主要结果指标是自我报告的身体功能。次要结果指标包括客观测量的下肢体能、行走耐力、平衡能力、行走速度、力量和体力活动,以及自我报告的跌倒、疼痛、疲劳和平衡能力。这是首批研究简短锻炼课程临床效果的研究之一,它可能会催生新一代的锻炼计划,这些计划不仅要优化效果,还要优化坚持性。
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来源期刊
CiteScore
3.70
自引率
4.50%
发文量
281
审稿时长
44 days
期刊介绍: Contemporary Clinical Trials is an international peer reviewed journal that publishes manuscripts pertaining to all aspects of clinical trials, including, but not limited to, design, conduct, analysis, regulation and ethics. Manuscripts submitted should appeal to a readership drawn from disciplines including medicine, biostatistics, epidemiology, computer science, management science, behavioural science, pharmaceutical science, and bioethics. Full-length papers and short communications not exceeding 1,500 words, as well as systemic reviews of clinical trials and methodologies will be published. Perspectives/commentaries on current issues and the impact of clinical trials on the practice of medicine and health policy are also welcome.
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