scholarly journals Evaluation of Clinical Outcomes and Simultaneous Digital Tracking of Daily Physical Activity, Heart Rate, and Inhalation Behavior in Patients With Pulmonary Arterial Hypertension Treated With Inhaled Iloprost: Protocol for the Observational VENTASTEP Study (Preprint)

2018 ◽  
Author(s):  
Christian Mueller ◽  
Barbara Stollfuss ◽  
Alexander Roitenberg ◽  
Jonas Harder ◽  
Manuel J Richter

BACKGROUND Pulmonary arterial hypertension (PAH)—a progressive, ultimately fatal disease—patients often experience dyspnea, which can limit their daily physical activities. Iloprost is an inhaled therapy for PAH that has shown efficacy in clinical trials. However, clinical trials in PAH have provided only limited data on daily physical activity. Digital monitoring of daily physical activity in PAH is therefore attracting growing interest. To fully understand a patient’s response to treatment, monitoring of treatment adherence is also required. The Breelib nebulizer for administration of iloprost saves inhalation data, thus allowing digital monitoring of adherence. OBJECTIVE This study aims to perform parallel digital tracking of daily physical activity parameters, heart rate, and iloprost inhalation data in patients with PAH, before and after starting inhaled iloprost treatment. The primary objective is to investigate correlations between changes in digital measures of daily physical activity and traditional clinical measures. Secondary objectives are to assess iloprost inhalation behavior, the association between daily physical activity measures and time since last inhalation, changes in sleep quality and heart rate, the association of heart rate with daily physical activity measures and iloprost inhalation, and adverse events. METHODS VENTASTEP is a digital, prospective, observational, multicenter, single-arm cohort study of adults with PAH in Germany, starting inhaled iloprost treatment via the Breelib nebulizer, in addition to existing PAH therapy. The study comprises a baseline period without iloprost treatment (≤2 weeks) and an observation period with iloprost treatment (3 months±2 weeks). The Apple Watch Series 2 and iPhone 6s are used with a dedicated study app to continuously measure digital daily physical activity parameters and heart rate during the baseline and observation periods; the watch is also used with a 6-min walk distance (6MWD) app to measure digital 6MWD at baseline and the end-of-observation visit. Inhalation frequency, completeness, and duration are monitored digitally via the nebulizer and the BreeConnect app. Sleep quality is assessed using the Pittsburgh Sleep Quality Index at baseline and the end-of-observation visit. Changes in traditional outcome measures (6MWD, Borg dyspnea scale, EuroQol 5-dimensions questionnaire, functional class, and brain natriuretic peptide [BNP] or N-terminal proBNP) between baseline and the end-of-observation visit will be correlated with changes in digital daily physical activity parameters and digital 6MWD as the primary analysis. RESULTS The first participant was enrolled in February 2018 (estimated study completion by July 2019; planned sample size: 80 patients). CONCLUSIONS The VENTASTEP study will inform future research on the utility of digital parameters as outcome assessment tools for disease monitoring in PAH. The study will also provide insight into clinical outcomes, daily physical activity, and quality of life in patients adding inhaled iloprost, to existing PAH therapy. CLINICALTRIAL ClinicalTrials.gov NCT03293407; https://clinicaltrials.gov/ct2/show/NCT03293407 (Archived by WebCite at http://www.webcitation.org/6ywPGcn4I) INTERNATIONAL REGISTERED REPOR DERR1-10.2196/12144

2021 ◽  
pp. 204589402199995
Author(s):  
Layse Nakazato Lima ◽  
Felipe Mendes ◽  
Ilma Paschoal ◽  
Daniela Oliveira ◽  
Marcos Mello Moreira ◽  
...  

Pulmonary arterial hypertension (PAH) impairs exercise tolerance and daily physical activity (PA). Aside from the hemodynamic limitations, physical, cognitive and emotional factors may play a relevant and as yet unexplored role. We investigated whether there is an association between the PA level and psychological disorders, health-related quality of life, and daily activities. We also searched for an association of the PA level with clinical factors and functional capacity. This was an analytical, cross-sectional, observational study conducted in a Brazilian University Hospital. Twenty stable PAH subjects wore an accelerometer for a week and completed an activity diary. They answered the quality of life questionnaire (SF-36), as well as the anxiety and depression scale (HADS), and the Manchester Respiratory Activities of Daily Living questionnaire (MRADL). Transthoracic echocardiography, the 6-Minute walk test (6MWT), the 1-minute sit-to-stand test (STST), and spirometry were performed. For statistical analysis we used Chi-square tests or Fisher's test as appropriate and the Mann-Whitney test to compare numerical values between two groups. The relationship between the parameters was assessed using the Spearman correlation test. The mean age was 44.3 years, 80% were women, 80% had idiopathic PAH, and 20% had connective tissue disease . The mean daily step count was 4,280 ± 2,351, and the mean activity time was 41.6 ± 19.3 minutes. The distance covered (6MWT) was 451.5 m, and the number of movements (1-STST) was 23.8. Thirty percent scored positive for anxiety, and 15% for depression (HADS). There was a significant correlation between accelerometer data and walking distance (6MWT), number of movements (1-STST), level of daily physical activity (MRADL), and depression symptoms. Our findings support the hypothesis that other aspects beyond physical and hemodynamic ones might impact the daily physical activity of patients with PAH.


1993 ◽  
Vol 5 (4) ◽  
pp. 357-366 ◽  
Author(s):  
Hazzaa M. Al-Hazzaa ◽  
Mohammed A. Sulaiman

The present study examined the relationship between maximal oxygen uptake (V̇O2max) and daily physical activity in a group of 7- to 12-year-old boys. V̇O2max was assessed through the incremental treadmill test using an open circuit system. Physical activity level was obtained from heart rate telemetry outside of school time for 8 hrs during weekdays and during 40 min of physical education classes. The findings indicated that the absolute value of V̇O2max increased with age, while relative to body weight it remained almost the same across age, with a mean of 48.4 ml · kg−1 · min−1. Moreover, heart rate telemetry showed that the boys spent a limited amount of time on activities that raise the heart rate to a level above 160 bpm (an average of 1.9%). In addition, V̇O2max was found to be significantly related to the percentage of time spent at activity levels at or above a heart rate of 140 bpm, but not with activity levels at or above a heart rate of 160 bpm.


2021 ◽  
Author(s):  
María Óskarsdóttir ◽  
Anna Sigridur Islind ◽  
Elias August ◽  
Erna Sif Arnardóttir ◽  
Francois Patou ◽  
...  

BACKGROUND The method considered the gold standard for recording sleep is a polysomnography, where the measurement is performed in a hospital environment for 1-3 nights. This requires subjects to sleep with a device and several sensors attached to their face, scalp, and body, which is both cumbersome and expensive. For longer studies with actigraphy, 3-14 days of data collection is typically used for both clinical and research studies. OBJECTIVE The primary goal of this paper is to investigate if the aforementioned timespan is sufficient for data collection, when performing sleep measurements at home using wearable and non-wearable sensors. Specifically, whether 3-14 days of data collection sufficient to capture an individual’s sleep habits and fluctuations in sleep patterns in a reliable way for research purposes. Our secondary goals are to investigate whether there is a relationship between sleep quality, physical activity, and heart rate, and whether individuals who exhibit similar activity and sleep patterns in general and in relation to seasonality can be clustered together. METHODS Data on sleep, physical activity, and heart rate was collected over a period of 6 months from 54 individuals in Denmark aged 52-86 years. The Withings Aura sleep tracker (non-wearable) and Withings Steel HR smartwatch (wearable) were used. At the individual level, we investigated the consistency of various physical activities and sleep metrics over different time spans to illustrate how sensor data from self-trackers can be used to illuminate trends. RESULTS Significant variability in standard metrics of sleep quality was found between different periods throughout the study. We show specifically that in order to get more robust individual assessment of sleep and physical activity patterns through wearable and non-wearable devices, a longer evaluation period than 3-14 days is necessary. Additionally, we found seasonal patterns in sleep data related to changing of the clock for Daylight Saving Time (DST). CONCLUSIONS We demonstrate that over two months worth of self-tracking data is needed to provide a representative summary of daily activity and sleep patterns. By doing so, we challenge the current standard of 3-14 days for sleep quality assessment and call for rethinking standards when collecting data for research purposes. Seasonal patterns and DST clock change are also important aspects that need to be taken into consideration, and designed for, when choosing a period for collecting data. Furthermore, we suggest using consumer-grade self-trackers (wearable and non-wearable ones) to support longer term evaluations of sleep and physical activity for research purposes and, possibly, clinical ones in the future.


2002 ◽  
Vol 282 (3) ◽  
pp. R649-R657 ◽  
Author(s):  
Yasuhiro Nishida ◽  
Qing Hui Chen ◽  
Ming-Sheng Zhou ◽  
Jouji Horiuchi

It has been speculated that if baroafferent signals are only related to the negative feedback control of arterial pressure (AP), then physical activity would increase the range of AP fluctuation in baroafferent-denervated animals. Mean AP (MAP), heart rate (HR), and cardiac output (CO) were measured for 24 h in free-moving conscious rabbits. On the basis of hydrostatic pressure and electromyogram, MAP data taken during periods of physical activity and rest were selected from the overall 24-h MAP data and then converted into histograms. During physical activity, the mode of MAP histogram increased in intact rabbits and was unchanged in sinoaortic-denervated (SAD) rabbits. Movement increased the mode of total peripheral resistance (TPR) but did not significantly change CO in intact rabbits. Conversely in SAD rabbits, movement slightly decreased TPR and slightly increased CO. These findings indicate that arterial baroafferent signals are required to shift MAP to a higher pressure level by an increase in TPR but not in CO during a moving phase. These results suggest that baroafferent signals may not only minimize the fluctuating range of MAP through negative feedback control but also be involved in actively resetting MAP toward a higher pressure level during daily physical activity.


2009 ◽  
Vol 135 (2) ◽  
pp. 257-259 ◽  
Author(s):  
Lidiane Sousa ◽  
Manoel Otávio da Costa Rocha ◽  
Raquel Rodrigues Britto ◽  
Federico Lombardi ◽  
Antonio L. Ribeiro

2015 ◽  
Vol 2015 ◽  
pp. 1-11 ◽  
Author(s):  
David M. Hallman ◽  
Svend Erik Mathiassen ◽  
Eugene Lyskov

Background. We determined the extent to which heart rate variability (HRV) responses to daily physical activity differ between subjects with and without chronic neck pain.Method. Twenty-nine subjects (13 women) with chronic neck pain and 27 age- and gender-matched healthy controls participated. Physical activity (accelerometry), HRV (heart rate monitor), and spatial location (Global Positioning System (GPS)) were recorded for 74 hours. GPS data were combined with a diary to identify periods of work and of leisure at home and elsewhere. Time- and frequency-domain HRV indices were calculated and stratified by period and activity type (lying/sitting, standing, or walking). ANCOVAs with multiple adjustments were used to disclose possible group differences in HRV.Results. The pain group showed a reduced HRV response to physical activity compared with controls (p=.001), according to the sympathetic-baroreceptor HRV index (LF/HF, ratio between low- and high-frequency power), even after adjustment for leisure time physical activity, work stress, sleep quality, mental health, and aerobic capacity (p=.02). The parasympathetic response to physical activity did not differ between groups.Conclusions. Relying on long-term monitoring of physical behavior and heart rate variability, we found an aberrant sympathetic-baroreceptor response to daily physical activity among subjects with chronic neck pain.


2015 ◽  
Author(s):  
Timur Nuritdinow ◽  
Christian Lederer ◽  
Martin Daumer

Mobile accelerometry is more and more being used in clinical trials as a tool to measure outcomes related to physical activity. However, it is still difficult to integrate exercise therapy in controlled clinical trials. We want to explore the option to use a unified platform to both measure outcome and prescribe and monitor exercise therapy using the actibelt technology platform. We present a prototype based on the actibelt platform that allows to use the wearable device as a mouse controller for a large set of potentially interesting games. Playing an exergame a person is encouraged to increase its level of daily motion while engaging in an activity that is perceived as interesting and fun, thus, providing an intrinsic motivation. Studies suggest that exergaming can be compared to light or moderate physical activity considering the heart rate, oxygen consumption and energy expenditure.


1989 ◽  
Vol 26 (6) ◽  
pp. 497-502
Author(s):  
Katsumi MITA ◽  
Naotaka ISHIDA ◽  
Toshiaki MIYAGAWA ◽  
Kumi AKATAKI ◽  
Tamotsu FUKUTANI ◽  
...  

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