1 Department of Rehabilitation Sciences, and.
2 Department of Respiratory Diseases, University Hospitals Leuven, Leuven, Belgium.
Am J Respir Crit Care Med. 2018 Oct 15;198(8):1021-1032. doi: 10.1164/rccm.201706-1288OC.
Bronchodilation and exercise training (ExT) improve exercise tolerance in patients with chronic obstructive pulmonary disease (COPD); however, behavior modification is required to impact daily physical activity (PA).
To assess whether tiotropium/olodaterol, with or without ExT, would improve exercise endurance time (EET) and PA compared with placebo in patients participating in a self-management behavior-modification (SMBM) program.
This was a 12-week, randomized, partially double-blind, placebo-controlled, parallel-group trial in patients with COPD (PHYSACTO; NCT02085161). All patients were enrolled into SMBM and randomized 1:1:1:1 to once-daily placebo, tiotropium 5 μg, tiotropium/olodaterol 5/5 μg, or tiotropium/olodaterol 5/5 μg plus 8 weeks ExT. EET, measured by endurance shuttle walk test after 8 weeks, was the primary endpoint. Additional endpoints assessed downstream effects on PA (measured via accelerometry), and activity-related dyspnea and difficulty (using validated patient-reported questionnaires).
SMBM plus tiotropium/olodaterol, with or without ExT, significantly improved EET at Week 8 versus SMBM plus placebo (treatment ratio vs. placebo: with ExT, 1.46; 95% confidence interval, 1.20-1.78; P = 0.0002; without ExT, 1.29; 95% confidence interval, 1.06-1.57; P = 0.0109). No significant increases in steps per day from baseline were observed over SMBM plus placebo at Week 12 (increase of 1,098) when other therapies were added. Adding tiotropium/olodaterol, with or without ExT, to SMBM reduced activity-related dyspnea versus placebo, whereas adding tiotropium/olodaterol plus ExT reduced activity-related difficulty.
Tiotropium/olodaterol, with or without ExT, improved EET in patients with COPD taking part in an SMBM program. Combination bronchodilation, with or without ExT, did not provide additional increases in objective PA compared with SMBM alone but did reduce PA-related dyspnea and difficulty. Clinical trial registered with www.clinicaltrials.gov (NCT02085161).
支气管扩张剂和运动训练（ExT）可提高慢性阻塞性肺疾病（COPD）患者的运动耐量；然而，需要行为改变来影响日常体力活动（PA）。
评估噻托溴铵/奥达特罗联合或不联合 ExT 是否能改善参加自我管理行为改变（SMBM）计划的患者的运动耐力时间（EET）和 PA，与安慰剂相比。
这是一项为期 12 周的随机、部分双盲、安慰剂对照、平行组试验，纳入了 COPD 患者（PHYSACTO；NCT02085161）。所有患者均参加 SMBM，并以 1:1:1:1 的比例随机分为每日一次安慰剂、噻托溴铵 5μg、噻托溴铵/奥达特罗 5/5μg 或噻托溴铵/奥达特罗 5/5μg 加 8 周 ExT。8 周后通过耐力穿梭步行试验测量 EET，这是主要终点。其他终点是评估对 PA（通过加速度计测量）的下游影响，以及与活动相关的呼吸困难和困难（使用经过验证的患者报告问卷）。
SMBM 加噻托溴铵/奥达特罗，联合或不联合 ExT，与 SMBM 加安慰剂相比，在第 8 周时显著改善 EET（治疗比值与安慰剂：有 ExT，1.46；95%置信区间，1.20-1.78；P=0.0002；无 ExT，1.29；95%置信区间，1.06-1.57；P=0.0109）。当添加其他治疗时，12 周时从 SMBM 加安慰剂开始，每天的步数没有明显增加（增加 1098 步）。SMBM 加噻托溴铵/奥达特罗，联合或不联合 ExT，与安慰剂相比，减轻了与活动相关的呼吸困难，而 SMBM 加噻托溴铵/奥达特罗加 ExT 减轻了与活动相关的困难。
在参加 SMBM 计划的 COPD 患者中，噻托溴铵/奥达特罗联合或不联合 ExT 可提高 EET。与单独 SMBM 相比，联合支气管扩张剂，联合或不联合 ExT，并未增加客观 PA，但确实减轻了与 PA 相关的呼吸困难和困难。临床试验在 www.clinicaltrials.gov 注册（NCT02085161）。
