Hammersmith Hospital, Imperial College Healthcare NHS Trust, London, England.
Heart Centera, University Hospital Cologne, and Cologne Cardiovascular Research Center (CCRC), Cologne, Germany.
Chest. 2023 Feb;163(2):407-418. doi: 10.1016/j.chest.2022.08.2231. Epub 2022 Sep 8.
Reduced daily life physical activity (DLPA) in pulmonary arterial hypertension (PAH) contributes to a poor quality of life.
Can actigraphy be used to assess changes in DLPA in patients with PAH receiving selexipag or placebo?
Effect of Selexipag on Daily Life Physical Activity of Patients With Pulmonary Arterial Hypertension (TRACE) was a prospective, multicenter, randomized, placebo-controlled, double-blind, exploratory phase 4 study enrolling patients with PAH in World Health Organization functional class II/III, receiving stable endothelin receptor antagonist with/without phosphodiesterase type 5 inhibitor background therapy. Primary end points were change from baseline to Week 24 in actigraphy-assessed DLPA (recorded by using an accelerometer), including daily time spent in nonsedentary physical activity (NSPA), daily time spent in moderate to vigorous physical activity (MVPA), daily volume of activity, and daily number of steps.
At baseline, patients (N = 108) were prevalent, on stable background PAH therapy, and at low risk of disease progression. Patients showed high compliance with wear of the accelerometer throughout the study. From baseline to Week 24, mean daily time spent in NSPA increased by 1.1 min and decreased by 16.7 min in the selexipag and placebo groups (treatment difference [95% CI], 17.8 [-6.0, 41.6] min); mean time spent in MVPA increased by 0.3 min and was reduced by 2.0 min in the selexipag and placebo groups (treatment difference [95% CI], 2.3 [-10.8, 15.4] min); and mean number of daily steps decreased by 0.3 and 201.9 in the selexipag and placebo groups (treatment difference [95% CI], 201.6 [-243.0, 646.2]).
TRACE enrolled a prevalent population on background therapy and at low risk of disease progression. Changes in DLPA were small and highly variable, with no statistically significant differences between treatment groups. This patient-centric study was the first randomized trial in PAH to capture high-quality actigraphy data and to describe DLPA in terms of mean/median and variability, which may inform the design of future studies.
ClinicalTrials.gov; No.: NCT03078907; URL: www.
gov.
肺动脉高压（PAH）患者日常生活体力活动减少会导致生活质量下降。
在接受西地那非或安慰剂的 PAH 患者中，运动活动记录仪能否用于评估日常生活体力活动的变化？
肺动脉高压患者西地那非对日常生活体力活动影响的研究（TRACE）是一项前瞻性、多中心、随机、安慰剂对照、双盲、探索性的 4 期研究，招募了世界卫生组织功能分类 II/III 级的 PAH 患者，正在接受稳定的内皮素受体拮抗剂，有/无磷酸二酯酶 5 抑制剂背景治疗。主要终点是从基线到第 24 周运动活动记录仪评估的日常生活体力活动（通过加速度计记录）的变化，包括非久坐体力活动（NSPA）的日常时间、中等到剧烈体力活动（MVPA）的日常时间、日常活动量和日常步数。
在基线时，患者（N=108）患有稳定的背景 PAH 治疗且处于疾病进展低风险的情况下。患者在整个研究期间对佩戴加速度计具有高度的依从性。从基线到第 24 周，西地那非组的 NSPA 日常时间增加了 1.1 分钟，减少了 16.7 分钟，安慰剂组则减少了 17.8 分钟（[95%置信区间]，17.8 [-6.0，41.6] 分钟）；西地那非组的 MVPA 日常时间增加了 0.3 分钟，减少了 2.0 分钟，安慰剂组则减少了 2.3 分钟（[95%置信区间]，2.3 [-10.8，15.4] 分钟）；西地那非组的日常步数减少了 0.3 步，减少了 201.9 步，安慰剂组减少了 201.6 步（[95%置信区间]，201.6 [-243.0，646.2] 步）。
TRACE 招募了处于背景治疗且疾病进展风险低的患者。日常生活体力活动的变化很小，且高度可变，治疗组之间无统计学差异。这项以患者为中心的研究是 PAH 中首次使用运动活动记录仪捕获高质量数据并描述日常生活体力活动的平均值/中位数和变异性的随机试验，可能为未来的研究提供参考。
ClinicalTrials.gov；编号：NCT03078907；网址：www.clinicaltrials.gov。
ClinicalTrials.gov。
