TY - JOUR
T1 - Assessing Daily Life Physical Activity by Actigraphy in Pulmonary Arterial Hypertension
T2 - Insights From the Randomized Controlled Study With Selexipag (TRACE)
AU - Howard, Luke S.
AU - Rosenkranz, Stephan
AU - Frantz, Robert P.
AU - Hemnes, Anna R.
AU - Pfister, Thomas
AU - Hsu Schmitz, Shu Fang
AU - Skåra, Hall
AU - Humbert, Marc
AU - Preston, Ioana R.
N1 - Funding Information:
This study was funded by Actelion Pharmaceuticals Ltd , a Janssen Pharmaceutical Company of Johnson & Johnson .
Funding Information:
Other contributions: The authors thank Yoko Shiraga, MSc, for her contribution to statistical analyses and comments on the manuscript. Medical writing support was provided by Iain Haslam, PhD, and Laura Corbett, PhD, of eluSCIdate Ltd, Meggen, Switzerland and was funded by Actelion Pharmaceuticals Ltd, a Janssen Pharmaceutical Company of Johnson & Johnson.
Publisher Copyright:
© 2022 The Author(s)
PY - 2023/2
Y1 - 2023/2
N2 - Background: Reduced daily life physical activity (DLPA) in pulmonary arterial hypertension (PAH) contributes to a poor quality of life. Research Question: Can actigraphy be used to assess changes in DLPA in patients with PAH receiving selexipag or placebo? Study Design and Methods: 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. Results: 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]). Interpretation: 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. Clinical Trial Registration: ClinicalTrials.gov; No.: NCT03078907; URL: www.clinicaltrials.gov
AB - Background: Reduced daily life physical activity (DLPA) in pulmonary arterial hypertension (PAH) contributes to a poor quality of life. Research Question: Can actigraphy be used to assess changes in DLPA in patients with PAH receiving selexipag or placebo? Study Design and Methods: 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. Results: 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]). Interpretation: 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. Clinical Trial Registration: ClinicalTrials.gov; No.: NCT03078907; URL: www.clinicaltrials.gov
KW - actigraphy
KW - daily life physical activity
KW - pulmonary arterial hypertension
KW - quality of life
KW - selexipag
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U2 - 10.1016/j.chest.2022.08.2231
DO - 10.1016/j.chest.2022.08.2231
M3 - Article
C2 - 36089068
AN - SCOPUS:85142494182
SN - 0012-3692
VL - 163
SP - 407
EP - 418
JO - Diseases of the chest
JF - Diseases of the chest
IS - 2
ER -