Actigraphy — a noninvasive method for measuring physical activity — can be effectively used to identify changes in daily life physical activity (DLPA) that may affect the quality of life (QoL) in patients with pulmonary arterial hypertension (PAH), according to clinical trial findings published in the journal CHEST.
Although previous research shows reduced DLPA can substantially affect quality of life in patients with PAH, DLPA is not usually assessed in PAH trials. The prospective, phase 4 TRACE study (ClinicalTrials.gov identifier: NCT03078907), which assessed the effect of the oral selective prostacyclin receptor agonist selexipag in patients with PAH, was unique in its use of actigraphy to monitor and measure DLPA, stressed study authors.
The TRACE trial, conducted across 29 sites in 10 countries from November 2017 through February 2020, included 108 patients (aged 18 to 75 years) with World Health Organization (WHO) functional class 1/2 PAH. The primary study endpoints were change from baseline to week 24 in actigraphy-evaluated DLPA (recorded via an accelerometer worn on the patient’s wrist), which included daily time spent in nonsedentary physical activity (NSPA; minutes and percent of wake time), daily time spent in moderate to vigorous physical activity (MVPA), daily volume of activity, and number of steps.
The trial comprised 2 patient cohorts: 53 patients randomly assigned to receive selexipag, and 55 patients receiving placebo. At baseline, all 108 patients were receiving stable background therapy for PAH and were at low risk for disease progression. Throughout the study, all patients demonstrated high compliance with using a wrist-worn accelerometer, which continually recorded DLPA throughout the 24-week study period. Data from the accelerometers were uploaded daily via smart-phone technology. Patients also attended clinic visits and completed various tests throughout the study period.
The investigators found that from baseline to week 24, participants’ mean daily time spent in nonsedentary physical activity increased by 1.1 minutes and decreased by 16.7 minutes in the selexipag and placebo groups, respectively (treatment difference, 17.8 minutes; 95% CI, –6.0 to 41.6 minutes). The mean time spent in MVPA increased by 0.3 minutes in the selexipag arm and decreased by 2.0 minutes in the placebo arm during the study period (treatment difference, 2.3 minutes; 95% CI, –10.8 to 15.4 minutes).
Additionally, the mean number of daily steps decreased by 0.3 in the selexipag group vs by 201.9 in the placebo group at week 24 (treatment difference, 201.6; 95% CI, –243.0 to 646.2). Small changes from baseline were also reported in the other parameters for both treatment groups, with no significant treatment differences observed.
This study was limited by its short time period, the small changes involved, and the small sample size, all of which may have affected the study’s ability to detect treatment differences between the selexipag and placebo groups.
TRACE investigators concluded that although changes in DLPA were small and highly variable between the selexipag and placebo groups, with no statistically significant differences between the groups, the study nevertheless “was the first randomised 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.”
Disclosure: Some of the study authors have declared affiliations with biotech, pharmaceutical, and/or device companies. Please see the original reference for a full list of authors’ disclosures.
Howard LS, Rosenkranz S, Frantz RP, et al. Assessing daily life physical activity by actigraphy in PAH: insights from the randomised controlled study with selexipag (TRACE). Chest. Published online September 8, 2022. doi:10.1016/j.chest.2022.08.2231