Effect of 12-week pulmonary rehabilitation on cognitive function in patients with stable chronic obstructive pulmonary disease: study protocol for a single-center randomised controlled trial.

Effect of 12-week pulmonary rehabilitation on cognitive function in patients with stable chronic obstructive pulmonary disease: study protocol for a single-center randomised controlled trial.
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12周肺康复对稳定型慢性阻塞性肺疾病患者认知功能的影响:单中心随机对照试验研究方案

DOI:
10.1136/bmjopen-2020-037307
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发表时间:
2020-10-16
期刊:
影响因子:
2.9
通讯作者:
Liu X
Liu X
中科院分区:
医学3区
文献类型:
--
作者:
Duan H;Li P;Wang Z;Chen H;Wang T;Wu W;Liu X

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认知功能障碍是慢性阻塞性肺疾病(COPD)患者的重要并发症,严重影响疾病的自我管理和生活质量。作为一种基于运动的干预计划,肺康复(PR)-特别是有氧运动(主要是身心运动)和阻力运动(RE)-已被提出,其潜在的有效性,在改善认知功能。然而,仍然缺乏强有力的证据证明公关的有效性。本研究旨在明确以肺功为主的气功锻炼和以弹力带为主的RE对COPD患者认知功能的影响,填补相关证据空白。本研究是一项单中心随机对照试验,评估者和数据分析员设盲。我们将于2019年12月23日开始招募108名COPD稳定期受试者,并将其按1:1:1:1的比例随机分配到肺功锻炼组、弹力带RE组、肺功和弹力带RE联合组或对照组。干预组的参与者将每天进行两次30分钟的运动,每周5天,持续12周。主要结局将是通过蒙特利尔认知评估和听觉事件相关电位P300评估的整体认知功能。次要结果将包括特定的认知领域-注意力、记忆力、执行功能、语言流畅性和心理处理速度;心理功能和生活质量。探索性结局将包括灰质体积和炎症介质水平。将在干预前后衡量结果。本品已获得中国上海中医药大学附属岳阳中西医结合医院伦理委员会的伦理批准(批准号:2019-141)。在进行任何程序之前,将获得每名受试者的书面知情同意书。研究结果将发表在同行评审期刊上,并在学术会议上发表。ChiCTR 1900026869;预结果。
Cognitive impairment, an important complication in patients with chronic obstructive pulmonary disease (COPD), seriously affects self-management of the disease and quality of life (QoL). As an exercise-based intervention programme, pulmonary rehabilitation (PR)—especially aerobic exercise (mainly mind–body exercise) and resistance exercise (RE)—has been proposed for its potential effectiveness in improving cognitive function. However, there is still a lack of strong evidence for PR’s effectiveness. In this study, we expect to clarify the effects of pulmonary-based Qigong exercise and elastic band-based RE on cognitive function in patients with COPD and to fill in the relevant evidence blanks. This study is a single-centre randomised controlled trial with assessor and data analyst blinding. We will recruit 108 participants with stable COPD starting on 23 December 2019, and randomly allocate them into the pulmonary-based Qigong exercise group, elastic band-based RE group, pulmonary-based Qigong exercise and elastic band-based RE combined group, or control group at a 1:1:1:1 ratio. Participants in intervention groups will perform 30 min of exercise two times per day, 5 days a week, for 12 weeks. The primary outcome will be the global cognitive function as assessed by the Montreal Cognitive Assessment and auditory event-related potential P300. Secondary outcomes will include the specific cognitive domains—attention, memory, executive function, verbal fluency and mental-processing speed; psychological functions and QoL. Exploratory outcomes will include grey matter volume and levels of inflammatory mediators. Outcomes will be measured before and after the interventions. Ethics approval has been granted by the Ethics Committee of Yue-Yang Integrative Medicine Hospital, an affiliate of Shanghai University of Traditional Chinese Medicine, Shanghai, China (Grant No. 2019-141). Written informed consent will be obtained from each participant before any procedures are performed. The findings will be published in peer-reviewed journals and presented at academic conferences. ChiCTR1900026869; pre-results.
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