Beekman Emmylou, Mesters Ilse, Hendriks Erik J M, Muris Jean W M, Wesseling Geertjan, Evers Silvia M A A, Asijee Guus M, Fastenau Annemieke, Hoffenkamp Hannah N, Gosselink Rik, van Schayck Onno C P, de Bie Rob A
Department of Epidemiology, CAPHRI School for Public Health and Primary Care, Maastricht University, PO Box 616, Maastricht, MD 6200, The Netherlands.
BMC Pulm Med. 2014 Apr 26;14:71. doi: 10.1186/1471-2466-14-71.
Physical exercise training aims at reducing disease-specific impairments and improving quality of life in patients with chronic obstructive pulmonary disease (COPD). COPD exacerbations in particular negatively impact COPD progression. Physical therapy intervention seems indicated to influence exacerbations and their consequences. However, information on the effect of physical therapy on exacerbation occurrence is scarce. This study aims to investigate the potential of a protocol-directed physical therapy programme as a means to prevent or postpone exacerbations, to shorten the duration or to decrease the severity of exacerbations in patients with COPD who have recently experienced an exacerbation. Besides, this study focuses on the effect of protocol-directed physical therapy on health status and quality of life and on cost-effectiveness and cost-utility in patients with COPD who have recently experienced an exacerbation.
METHODS/DESIGN: A prospective cohort of 300 COPD patients in all GOLD stages will be constructed. Patients will receive usual multidisciplinary COPD care including guideline-directed physical therapy. Patients in this cohort who have GOLD stage 2 to 4 (post-bronchodilator FEV1/FVC < 0.7 and FEV1 < 80% of predicted), who receive reimbursement by health insurance companies for physical therapy (post-bronchodilator Tiffeneau-index < 0.6) and who experience a COPD exacerbation will be asked within 56 days to participate in a cohort-nested prospective randomised controlled trial (RCT). In this RCT, the intervention group will receive a strict physical therapy programme for patients with COPD. This protocol-directed physical therapy (pdPT) will be compared to a control group that will receive sham-treatment, meaning no or very low-intensity exercise training (ST). An economic evaluation will be embedded in the RCT. Anthropometric measurements, comorbidities, smoking, functional exercise capacity, peripheral muscle strength, physical activity level, health related quality of life, patients' perceived benefit, physical therapy compliance, motivation level, level of effective mucus clearance, exacerbation symptoms and health care contacts due to COPD will be recorded. Follow-up measurements are scheduled at 3 and 6 weeks, 3, 6, 12 and 24 months after inclusion.
Ways to minimise potential problems regarding the execution of this study will be discussed.
The Netherlands National Trial Register NTR1972.
体育锻炼训练旨在减轻慢性阻塞性肺疾病（COPD）患者的特定疾病损伤并改善其生活质量。尤其是COPD急性加重会对COPD的进展产生负面影响。物理治疗干预似乎有助于影响急性加重及其后果。然而，关于物理治疗对急性加重发生的影响的信息很少。本研究旨在调查针对方案的物理治疗计划作为预防或推迟COPD患者急性加重、缩短急性加重持续时间或减轻急性加重严重程度的一种手段的潜力。此外，本研究关注针对方案的物理治疗对近期经历过急性加重的COPD患者的健康状况和生活质量以及成本效益和成本效用的影响。
方法/设计：将构建一个包含所有GOLD阶段的300名COPD患者的前瞻性队列。患者将接受常规的多学科COPD护理，包括遵循指南的物理治疗。该队列中处于GOLD 2至4期（支气管扩张剂后FEV1/FVC < 0.7且FEV1 < 预测值的80%）、接受健康保险公司物理治疗报销（支气管扩张剂后蒂芬诺指数 < 0.6）且经历过COPD急性加重的患者将在56天内被邀请参加一项队列嵌套的前瞻性随机对照试验（RCT）。在该RCT中，干预组将接受针对COPD患者的严格物理治疗计划。这种针对方案的物理治疗（pdPT）将与接受假治疗的对照组进行比较，假治疗意味着不进行或进行极低强度的运动训练（ST）。一项经济评估将纳入该RCT。将记录人体测量学指标、合并症、吸烟情况、功能运动能力、外周肌肉力量、身体活动水平、健康相关生活质量、患者感知的益处、物理治疗依从性、动机水平、有效痰液清除水平、急性加重症状以及因COPD导致的医疗接触情况。随访测量计划在纳入后的3周和6周、3个月、6个月、12个月和24个月进行。
将讨论尽量减少本研究执行过程中潜在问题的方法。
荷兰国家试验注册NTR1972。
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