慢性呼吸道疾病患者虚弱的康复干预（加强研究）：一项多中心随机对照试验的研究方案
Rehabilitative intervention of frailty for patients with chronic respiratory disease (REINFORCE study): research protocol for a multicentre, randomised controlled trial.
摘要(中文译文)
肺康复，主要以运动训练为主，在慢性阻塞性肺疾病（COPD）患者中已得到充分确立；然而，专门针对慢性呼吸系统疾病（CRD）患者躯体衰弱的康复干预尚未被探索。本研究评估一项针对老年CRD患者衰弱的康复干预（REINFORCE），涵盖多种肺部疾病。这项多中心、前瞻性、随机对照试验将纳入184例CRD患者。患者将接受为期4周的项目，重点针对身体功能下降，采用简易体能状况量表（SPPB）项目进行测量，如平衡、步行和/或坐立试验。主要结局是两组之间项目前后作为身体活动指标的每日步数变化。次要结局包括4周和1年时SPPB评分、外周肌力（握力和股四头肌）、6分钟步行距离（6MWD）和健康相关生活质量（HRQL）评分的变化。REINFORCE研究旨在成为首批针对CRD衰弱的随机试验之一，旨在探索一种改善身体活动水平的新型干预措施的可行性和潜在获益。该随机对照试验已于2024年6月1日在大学医院医疗信息网络临床试验注册中心（UMIN-CTR）前瞻性注册，注册号为UMIN000053979。
Abstract
Pulmonary rehabilitation, primarily with exercise training, is well-established for patients with chronic obstructive pulmonary disease (COPD); however, rehabilitative intervention specifically targeting physical frailty in patients with chronic respiratory disease (CRD) remains unexplored. This study evaluates a rehabilitative intervention for frailty in older patients with CRDs (REINFORCE), including various lung diseases. This multicentre, prospective, randomised, controlled trial will enrol 184 patients with CRD. Patients will undergo a 4-week programme focused on addressing declined physical functions, as measured by the Short Physical Performance Battery (SPPB) items such as balance, walking, and/or sit-to-stand chair test. The primary outcome is the change in daily step count as a physical activity measure before and after the programme between the two groups. Secondary outcomes include changes in the SPPB score, peripheral muscle strength (handgrip and quadriceps), 6-minute walk distance (6MWD), and health-related quality of life (HRQL) scores at 4 weeks and 1 year. The REINFORCE study is designed to be one of the first randomised trials targeting frailty in CRD and aims to explore the feasibility and potential benefit of a novel intervention to improve physical activity levels. This randomised controlled trial was prospectively registered with the University Hospital Medical Information Network Clinical Trials Registry (UMIN-CTR) under the registration number UMIN000053979 on June 1, 2024.
如何引用
AMA
Tadayoshi Nonoyama, Masatoshi Hanada, Osamu Nishiyama, Shinichi Arizono, Kensuke Kataoka, Atsuhito Nakazawa, et al. Rehabilitative intervention of frailty for patients with chronic respiratory disease (REINFORCE study): research protocol for a multicentre, randomised controlled trial.. Journal of thoracic disease. 2026; doi:10.21037/jtd-2026-1-0426.
APA
Tadayoshi Nonoyama, Masatoshi Hanada, Osamu Nishiyama, Shinichi Arizono, Kensuke Kataoka, Atsuhito Nakazawa, et al (2026). Rehabilitative intervention of frailty for patients with chronic respiratory disease (REINFORCE study): research protocol for a multicentre, randomised controlled trial.. Journal of thoracic disease. https://doi.org/10.21037/jtd-2026-1-0426
GB/T 7714
Tadayoshi Nonoyama, Masatoshi Hanada, Osamu Nishiyama, Shinichi Arizono, Kensuke Kataoka, Atsuhito Nakazawa, et al. Rehabilitative intervention of frailty for patients with chronic respiratory disease (REINFORCE study): research protocol for a multicentre, randomised controlled trial.[J]. Journal of thoracic disease, 2026 doi:10.21037/jtd-2026-1-0426.
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