Engel Roger, Grace Sandra, Broadbent Suzanne
Department of Chiropractic, Macquarie University, North Ryde, Sydney, NSW, 2109, Australia.
School of Health and Human Sciences, Southern Cross University, Lismore, Australia.
Trials. 2019 Mar 13;20(1):163. doi: 10.1186/s13063-019-3257-z.
Ageing is associated with a range of anatomical and physiological changes. Establishing whether a change is part of 'normal' ageing or the early signs of disease will affect management strategies. Progressive stiffening of the thoracic spine, decreasing chest wall compliance and declining lung function begin as early as 40 years of age. Administering an intervention such as manual therapy, which has the potential to mitigate age-related changes in the thoracic spine and chest wall, has the potential to improve thoracic compliance and lung function. The aims of this trial are to investigate whether manual therapy can mitigate the effects of age-related changes in lung function and whether there is a difference in effect between different forms of manual therapy.
The study design is a randomised controlled trial of 372 people with no history of respiratory disease between the ages of 50 and 65 years. The cohort will be divided into three equal groups. The first group will receive a simple 10-min treadmill walking program (Ex). The second group will receive joint mobilisation (MB) of the thoracic spine and ribs plus the same walking program (MB + Ex). The third group will receive joint manipulation (MT) of the thoracic spine and ribs plus the same walking program (MT + Ex). All interventions will be administered a total of six times over a 3-week period. The primary outcome measure is lung function: forced expiratory volume in the 1st second and forced vital capacity. The secondary outcome measures include chest wall expansion (tape measurements) and quality of life measurements (36-Item Short Form Health Survey). Outcome measurements will be taken by blinded assessors on four occasions over a 9-week period. Adverse event data will be gathered at the beginning of each intervention session.
This randomised controlled trial is designed to investigate whether manual therapy can mitigate the effects of age-related changes in lung function and whether there is a difference in effect between different forms of manual therapy. This is the first fully powered trial designed to test this hypothesis on healthy males and females in this age range.
Australian New Zealand Clinical Trials Registry (ANZCTR), 12616001317482 . Registered on 20 September 2016.
衰老与一系列解剖学和生理学变化相关。确定一种变化是“正常”衰老的一部分还是疾病的早期迹象将影响管理策略。早在40岁时,胸椎就开始逐渐僵硬,胸壁顺应性降低,肺功能下降。实施诸如手法治疗等干预措施,有可能减轻胸椎和胸壁与年龄相关的变化,从而有可能改善胸壁顺应性和肺功能。本试验的目的是研究手法治疗是否能减轻与年龄相关的肺功能变化的影响,以及不同形式的手法治疗在效果上是否存在差异。
本研究设计为一项随机对照试验,纳入372名年龄在50至65岁之间且无呼吸系统疾病史的人。该队列将被平均分为三组。第一组将接受一个简单的10分钟跑步机步行计划(Ex)。第二组将接受胸椎和肋骨的关节松动术(MB)以及相同的步行计划(MB + Ex)。第三组将接受胸椎和肋骨的关节整复术(MT)以及相同的步行计划(MT + Ex)。所有干预措施将在3周内总共进行6次。主要结局指标是肺功能:第1秒用力呼气量和用力肺活量。次要结局指标包括胸壁扩张(卷尺测量)和生活质量测量(36项简短健康调查问卷)。结局测量将由盲法评估者在9周内进行4次。不良事件数据将在每次干预 session 开始时收集。
这项随机对照试验旨在研究手法治疗是否能减轻与年龄相关的肺功能变化的影响,以及不同形式的手法治疗在效果上是否存在差异。这是第一项有足够效力的试验,旨在针对这个年龄范围内的健康男性和女性检验这一假设。
澳大利亚新西兰临床试验注册中心(ANZCTR),12616001317482。于2016年9月20日注册。