Department of Physiotherapy, Austin Health, Melbourne, Australia.
BMC Pulm Med. 2013 Feb 1;13:8. doi: 10.1186/1471-2466-13-8.
Interstitial lung disease encompasses a diverse group of chronic lung conditions characterised by distressing dyspnoea, fatigue, reduced exercise tolerance and poor health-related quality of life. Exercise training is one of the few treatments to induce positive changes in exercise tolerance and symptoms, however there is marked variability in response. The aetiology and severity of interstitial lung disease may influence the response to treatment. The aims of this project are to establish the impact of exercise training across the range of disease severity and to identify whether there is an optimal time for patients with interstitial lung disease to receive exercise training.
METHODS/DESIGN: One hundred and sixteen participants with interstitial lung disease recruited from three tertiary institutions will be randomised to either an exercise training group (supervised exercise training twice weekly for eight weeks) or a usual care group (weekly telephone support). The 6-minute walk distance, peripheral muscle strength, health-related quality of life, dyspnoea, anxiety and depression will be measured by a blinded assessor at baseline, immediately following the intervention and at six months following the intervention. The primary outcome will be change in 6-minute walk distance following the intervention, with planned subgroup analyses for participants with idiopathic pulmonary fibrosis, dust-related interstitial lung disease and connective-tissue related interstitial lung disease. The effects of disease severity on outcomes will be evaluated using important markers of disease severity and survival, such as forced vital capacity, carbon monoxide transfer factor and pulmonary hypertension.
This trial will provide certainty regarding the role of exercise training in interstitial lung disease and will identify at what time point within the disease process this treatment is most effective. The results from this study will inform and optimise the clinical management of people with interstitial lung disease.
Australian New Zealand Clinical Trials Registry ACTRN12611000416998.
间质性肺疾病包括一组不同的慢性肺部疾病，其特征是令人痛苦的呼吸困难、疲劳、运动耐量降低和健康相关生活质量差。运动训练是为数不多的能够诱导运动耐量和症状改善的治疗方法之一，但反应存在显著差异。间质性肺疾病的病因和严重程度可能会影响治疗反应。本项目的目的是确定运动训练在疾病严重程度范围内的影响，并确定间质性肺疾病患者接受运动训练的最佳时间。
方法/设计：从三所三级医疗机构招募的 116 名间质性肺疾病患者将被随机分为运动训练组（每周两次接受监督运动训练，持续八周）或常规护理组（每周接受一次电话支持）。运动训练组将在基线时、干预结束后立即和干预结束后 6 个月时由盲法评估者测量 6 分钟步行距离、外周肌肉力量、健康相关生活质量、呼吸困难、焦虑和抑郁。主要结局将是干预后 6 分钟步行距离的变化，计划对特发性肺纤维化、尘肺相关间质性肺疾病和结缔组织相关间质性肺疾病患者进行亚组分析。使用重要的疾病严重程度和生存标志物（如用力肺活量、一氧化碳转移因子和肺动脉高压）来评估疾病严重程度对结局的影响。
该试验将提供关于运动训练在间质性肺疾病中的作用的确定性，并确定该治疗在疾病过程中的哪个时间点最有效。该研究的结果将为间质性肺疾病患者的临床管理提供信息并优化。
澳大利亚新西兰临床试验注册中心 ACTRN12611000416998。
Zotero 插件