Nolan Claire M, Glen Callum, Walsh Jessica A, Patel Suhani, Barker Ruth E, Polgar Oliver, Spain Nannette, Littlemore Hannah, Jung Peter, Edwards George D, Jenkins Timothy O, Harvey Jennifer, Ingram Karen, Newby Christopher, Steiner Michael, Wilson Rebecca, Gao Wei, Fiorentino Francesca, Chukwusa Emeka, May Peter, Maddocks Matthew, Man William D C
Department of Health Sciences, College of Health, Medicine, and Life Sciences, Brunel University of London, Uxbridge, Middlesex, UK.
Harefield Respiratory Research Group, Royal Brompton and Harefield Hospitals, Guy's and St Thomas' National Health Service Foundation Trust, Harefield, Middlesex, UK.
JAMA Netw Open. 2025 Aug 1;8(8):e2526616. doi: 10.1001/jamanetworkopen.2025.26616.
Pulmonary rehabilitation (PR) improves exercise tolerance, symptom burden, and health-related quality of life for people with chronic respiratory conditions. However, demand for PR outstrips supply. Traditionally, PR has been delivered using specialist, gym-based exercise equipment.
To investigate whether PR using minimal equipment (PR-min) is noninferior to PR using specialist gym exercise equipment (PR-gym).
DESIGN, SETTINGS, AND PARTICIPANTS: This parallel, 2-group, assessor- and statistician-blinded, noninferiority randomized clinical trial compared PR-min with PR-gym. Eligible participants were people with chronic respiratory disease referred for PR to the Regional Pulmonary Rehabilitation Unit in northwest London, UK. Recruitment occurred from October 15, 2018, to December 21, 2021, with a final follow-up to December 14, 2022. Randomization was by an independent web-based system using minimization with 1:1 allocation. Data analysis was performed from May 2023 to January 2025.
Both PR programs comprised 2 in-person, outpatient supervised sessions per week for 8 weeks. PR-min used minimal equipment (eg, walking circuit and body weight exercises), whereas PR-gym used specialist exercise equipment (eg, treadmills and weights machines).
The primary outcome was change in incremental shuttle walk (ISW) distance after PR (ie, at 8 weeks; with a predefined noninferiority margin of -24 m). Secondary outcomes included dyspnea, health-related quality of life, costs, and adverse events.
A total of 436 participants (median [IQR] age, 71.7 [63.2-77.7] years; 239 [54.8%] male) were enrolled, with 218 randomized to PR-min and 218 to PR-gym. At 8 weeks, PR-min (n = 136) and PR-gym (n = 130) demonstrated significant improvements in ISW distance with no significant between-group difference in ISW distance change (mean, 1.7 m; 1-sided 97.5% CI lower bound, -16.8), which was within the -24-m noninferiority margin. The intention-to-treat analysis and a robust range of sensitivity analyses all demonstrated that PR-min was noninferior to PR-gym. Similar findings were observed for dyspnea and health-related quality of life. No excess adverse events or costs were seen with intervention.
This randomized clinical trial found that PR-min demonstrated noninferiority to PR-gym for exercise capacity, dyspnea, and health-related quality of life. PR-min can expand the number of settings where PR can be provided, thus improving patient accessibility.
isrctn.org Identifier: ISRCTN16196765.
肺康复（PR）可提高慢性呼吸道疾病患者的运动耐量、症状负担及与健康相关的生活质量。然而，肺康复的需求超过了供给。传统上，肺康复是通过专业的、基于健身房的运动设备来进行的。
研究使用最少设备的肺康复（PR-min）是否不劣于使用专业健身房运动设备的肺康复（PR-gym）。
设计、地点和参与者：这项平行、两组、评估者和统计学家双盲的非劣效性随机临床试验将PR-min与PR-gym进行了比较。符合条件的参与者是被转诊至英国伦敦西北部地区肺康复科进行肺康复的慢性呼吸道疾病患者。招募时间为2018年10月15日至2021年12月21日，最终随访至2022年12月14日。随机分组通过一个独立的基于网络的系统，采用最小化法以1:1分配。数据分析于2023年5月至2025年1月进行。
两个肺康复项目均包括每周2次门诊面对面监督训练，共8周。PR-min使用最少的设备（如步行回路和体重训练），而PR-gym使用专业运动设备（如跑步机和举重器械）。
主要结局是肺康复后（即8周时）递增式往返步行（ISW）距离的变化（预设非劣效界值为-24米）。次要结局包括呼吸困难、与健康相关的生活质量、成本和不良事件。
共纳入436名参与者（年龄中位数[四分位间距]为71.7[63.2 - 77.7]岁；239名[54.8%]为男性），其中218名随机分配至PR-min组，218名分配至PR-gym组。在8周时，PR-min组（n = 136）和PR-gym组（n = 130）的ISW距离均有显著改善，两组间ISW距离变化无显著差异（均值为1.7米；单侧97.5%CI下限为-16.8），处于-24米的非劣效界值范围内。意向性分析和一系列稳健的敏感性分析均表明PR-min不劣于PR-gym。在呼吸困难和与健康相关的生活质量方面也观察到了类似的结果。干预后未发现额外的不良事件或成本。
这项随机临床试验发现，PR-min在运动能力、呼吸困难和与健康相关的生活质量方面不劣于PR-gym。PR-min可以扩大能够提供肺康复的场所数量，从而提高患者的可及性。
isrctn.org标识符：ISRCTN16196765。
