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Ethics approval and consent to participate | All study-related measures were performed in accordance with the ethical principles formulated by the Declaration of Helsinki in its current version. In conformity, the study protocol was reviewed and ethical approval was provided by both the institutional review boards of both University Medical Center Groningen (METc... | PMC10294515 | ||
Consent for publication | Not applicable. | PMC10294515 | ||
Competing interests | The authors declare no competing interests. | PMC10294515 | ||
References | PMC10294515 | |||
Introduction | JETLAG, ARTERIAL STIFFNESS | The discrepancy in sleep–wake timing between workdays and free (non-work) days due to modern work schedules possibly causes mild circadian misalignment between endogenous circadian rhythm and the sleep schedule imposed by social obligations. This jetlag-like phenomenon is called “social jetlag (SJL),” [In humans, blood... | PMC10477072 | |
Materials and methods | PMC10477072 | |||
Participants | hypertension, DBP] ≤, cardiovascular disease, diabetes | HYPERTENSION, CARDIOVASCULAR DISEASE, DIABETES | Twenty healthy men were recruited to participate in this study. All participants did not have a history of hypertension (systolic BP [SBP] ≤ 140 and diastolic BP [DBP] ≤ 90 mmHg), were nonsmokers, and were free of overt cardiovascular disease or diabetes, as assessed by medical history. All participants provided writte... | PMC10477072 |
Experimental design | The present study was an open-label, randomized crossover trial consisting of the SJL and control (CON) trials (Figure SAfter written informed consent was obtained, wearable devices (Fitbit Charge 5, Fitbit, CA, USA) were distributed to the participants to monitor sleep variables and energy balance throughout this stud... | PMC10477072 | ||
Week one | We started with a screening term to confirm sleep variables (bedtime, awake time, and mid-sleep time [median time between bedtime and awake time]) under free-living conditions for each participant from Wednesday in week one to Tuesday in week two. We confirmed that day-to-day intraindividual variation in mid-sleep time... | PMC10477072 | ||
Week two | ARTERIAL STIFFNESS | Resting hemodynamics, autonomic nervous system, cardiovagal baroreflex sensitivity (cvBRS), and central arterial stiffness were measured on Friday morning as pre-intervention measurement one. The participants were required to perform the SJL or CON trial from Friday night to Sunday morning. | PMC10477072 | |
Week three | Post-intervention measurement one was conducted on Monday morning, as with pre-intervention measurement one. Afterward, the participants were required to live according to everyday routine until Thursday as a washout term. Pre-intervention measurement two was conducted on Friday morning. The participants were then cros... | PMC10477072 | ||
Week four | Post-intervention measurement two was performed on Monday morning. After that, the participants were required to live according to routine life until Thursday as a follow-up. | PMC10477072 | ||
Social jetlag and control trials | In the SJL trial, the participants were required to delay their bedtime by 3 h on Friday and Saturday nights in week two or three (Figure S | PMC10477072 | ||
Pre- and post-intervention measurements | Pre- and post-intervention measurements were performed on Friday and Monday mornings; the participants were tested at the same time of day throughout the study period to avoid potential diurnal variations. Before these measurements, the participants were instructed to avoid food and caffeine and alcohol intake for at l... | PMC10477072 | ||
Body composition | The percentage of body fat and lean body mass was measured using bioelectrical impedance analysis (InBody 720, InBody, Tokyo, Japan) with the participants in the upright position. The validity of the device for measuring body composition has been confirmed by comparison with dual-energy x-ray absorptiometry, which is t... | PMC10477072 | ||
Central arterial stiffness | ARTERIAL STIFFNESS | The participants were studied under quiet resting conditions for 10 min in the supine position. Carotid-femoral pulse wave velocity (cfPWV), which is the gold standard for measuring central arterial stiffness [The coefficient of variation for the cfPWV was 4.9 ± 4.1% within the same participant. | PMC10477072 | |
Ambulatory blood pressure and heart rate | The ambulatory BP monitoring (ABPM) device (TM-2441, A&D Medical, Tokyo, Japan) automatically measured ambulatory BP and heart rate (HR) using the oscillometric method every 30–60 min during the sleep and awake period until measurement was completed for 2 h after wake-up. The ambulatory BP monitoring device has been co... | PMC10477072 | ||
Cardiovagal baroreflex sensitivity | Spontaneous cardiovagal baroreflex sensitivity (cvBRS) was determined from beat-to-beat changes in R–R interval (RRI) and SBP using an analysis software (Beatscope, version 1.1, Finapres Medical Systems, Amsterdam, The Netherlands). Three or more beats of progressive SBP changes and corresponding changes of RRI were id... | PMC10477072 | ||
HR and BP variabilities | HR variability (HRV) was measured as a reliable quantitative marker to assess the activity of the sympathetic and parasympathetic branches of the autonomic nervous system using HRV analysis module (MLS 310, AD Instruments, New South Wales, Australia). In the time domain, the root mean square of the squared differences ... | PMC10477072 | ||
Hemodynamics in rest | HR and beat-to-beat BP waveform were monitored using a three-lead electrocardiogram (BSM-2401, Nihon Kohden, Tokyo, Japan) and finger photoplethysmography (Finometer MIDI, Finapres Medical Systems, Amsterdam, The Netherlands), respectively. The latter instrument was attached to the middle finger of the left hand. The B... | PMC10477072 | ||
Statistical analyses | ARTERIAL STIFFNESS | A priori statistical power analysis was performed to determine the sample size needed for the present study using G*Power 3.1.9.6 [All data are expressed as mean ± standard deviation (SD). Statistical analyses were performed using IBM SPSS Statistics for Mac version 27.0 (IBM Corp., Armonk, N.Y., USA). The effects of t... | PMC10477072 | |
Results | PMC10477072 | |||
Data exclusion | Six participants were excluded from this study because four showed SJL of < 2 h in the SJL trial, and the ambulatory BP monitoring device did not work for two participants. Therefore, results were based on the remaining 14 participants who completed all measurements (Figure S | PMC10477072 | ||
Ambulatory blood pressure, heart rate, and physical activity | JETLAG | Table SFigure Time course of ambulatory systolic blood pressure (line chart) and physical activity (vertical bar chart) for 2 h before and after the awake time (n = 14). A vertical bar line means the awakening point as zero. Line charts show the time course of ambulatory systolic blood pressure as follows: open triangl... | PMC10477072 | |
Central arterial stiffness and morning BP | arterial stiffness | ARTERIAL STIFFNESS | Figure Central arterial stiffness ( | PMC10477072 |
Association between changes in central arterial stiffness, morning BP surge and sympathetic nerve activity in vessels | ARTERIAL STIFFNESS | Figure Association between changes in central arterial stiffness and morning blood pressure surge ( | PMC10477072 | |
Discussion | The significant finding of the present study was that acute SJL on weekends (181 ± 24 min) increased cfPWV and morning BP surge on Monday (Figs. | PMC10477072 | ||
Alteration of morning BP surge by acute social jetlag | SJL trial significantly augmented morning BP surge (Fig. As baroreceptors, located in the carotid artery and aortic arch, are stretch receptors, the deformation of the barosensory arterial wall is required to initiate neural firing [ | PMC10477072 | ||
Response of central arterial stiffness to acute SJL | OXIDATIVE STRESS, JET LAG | The cfPWV was significantly elevated during the SJL trial compared with pre-intervention (Fig. The mechanisms underlying acute SJL elevation of sympathetic nerve activity remain unclear. We can speculate that the phenomenon is attributed to circadian disruption caused by acute SJL. An animal study has shown that simula... | PMC10477072 | |
Response of central arterial stiffness and morning BP surge to acute SJL when including those who did not adhere to the intervention in the SJL trial | Although there were significant interactions in cfPWV, morning BP surge, and time course of ambulatory SBP, the significant interactions disappeared when including participants who did not adhere to the intervention in the SJL trial (SJL < 2 h). The results suggest that acute small SJL ( < 2 h) does not influence cardi... | PMC10477072 | ||
Study limitations | This study has some limitations. First, although we randomly assigned participants to two trials, the intervention was not performed in a blinded manner, which might have caused bias in the results. Second, we did not evaluate whether acute SJL altered circadian variables, such as clock gene expression levels and circa... | PMC10477072 | ||
Perspectives | strokes | EVENTS, ARTERIAL STIFFNESS, STROKES | Our findings may contribute to clarifying pathophysiological mechanisms to prevent the Monday morning-specific increase in cardiovascular events. It has been reported that cardiovascular events and strokes often occur on Mondays [In conclusion, acute SJL augments morning BP surge in the present study. Although this phe... | PMC10477072 |
Supplementary information | The online version contains supplementary material available at 10.1038/s41440-023-01360-5. | PMC10477072 | ||
Acknowledgements | We appreciate the support received from all the participants in this study. Moreover, we would like to thank Editage ( | PMC10477072 | ||
Funding | This work was supported by the JSPS KAKENHI to M Higuchi (Grant-in-Aid for Scientific Research [B], Grant Number: 18H03198). | PMC10477072 | ||
Author contributions | T.K., H.M. and N.N. conceived and designed the study. All authors conducted the experiments. N.N. and T.K. analyzed the data. All authors interpreted the data. N.N. and T.K. wrote the manuscript. | PMC10477072 | ||
Compliance with ethical standards | PMC10477072 | |||
Conflict of interest | The authors declare no competing interests. | PMC10477072 | ||
References | PMC10477072 | |||
Key words: | cardiovascular disease, breast cancer, cancer, cardiometabolic disease, metabolic syndrome, cardiometabolic dysfunction, metabolic abnormalities | CARDIOVASCULAR DISEASE, BREAST CANCER, CANCER, DYSFUNCTION, SECONDARY, METABOLIC SYNDROME | These two authors contributed equally to this workMetabolic dysfunction and excess accumulation of adipose tissue are detrimental side effects from breast cancer treatment. Diet and physical activity are important treatments for metabolic abnormalities, yet patient compliance can be challenging during chemotherapy trea... | PMC10404477 |
Abbreviations: | obesity, non-cancer, malignancy, Breast cancer, cancer, cardiometabolic disease, breast Cancer, cardiotoxicity, metabolic abnormalities, eating and reduced sedentary | OBESITY, CVD, INFLAMMATION, BREAST CANCER, CANCER | Breast cancer is the most commonly diagnosed malignancy in women worldwide, representing 25 % of annual new cancer casesThe direct toxic effects of breast cancer treatment on the heart (cardiotoxicity) are well characterised as a contributor to elevated CVD riskExcess accumulation of fat within ectopic regions (e.g. vi... | PMC10404477 |
Methods | PMC10404477 | |||
Study design, randomisation and blinding | IMPACT-Women is a two-site, two-arm, parallel-group superiority randomised controlled trial. Participants will be randomised 1:1 to the two groups using permutated blocks with random block sizes of two and four, stratified by study site, chemotherapy type (adjuvant/neoadjuvant), and postmenopausal status (yes/no). Rand... | PMC10404477 | ||
Ethics approval and registration | Both sites provide independent research ethics approval (HREBA.CC-22–0128; CAPCR.22–5374), which will be amended with protocol modifications. All participants will provide written informed consent. The trial is registered with clinicaltrials.gov (registration #NCT05432856). | PMC10404477 | ||
Participant eligibility | eating disorder, breast cancer | TYPE 1 DIABETES, TYPE 2 DIABETES, BREAST CANCER | We will recruit adult females (≥ 18 years) diagnosed with early-stage (I–III) breast cancer who will receive any type of neoadjuvant (pre-surgical) or adjuvant intravenous chemotherapy. Individuals without access to a cellphone with Bluetooth capability (required for intervention adherence tracking) will be excluded. W... | PMC10404477 |
Participant recruitment | cancer, Cancer | CANCER, CROSS, RECRUITMENT, CANCER | We anticipate that recruitment will start in January 2023 and be completed by December 2024. We will recruit from two Canadian university-affiliated cancer hospitals: the Princess Margaret Cancer Centre and the Cross Cancer Institute. At both sites, recruitment will be facilitated by the breast medical oncology circle ... | PMC10404477 |
Intervention | The intervention period will start shortly after randomisation and continue until the participant has completed all post-chemotherapy outcome assessments that occur 2–6 weeks after the last treatment (
Intervention and follow-up diagram. | PMC10404477 | ||
Time-restricted eating | Participants will be asked to follow 16:8 TRE, but with flexibility incorporated to personalise the protocol to adapt to the dynamic nature of treatment symptoms, as well as their lifestyle, or preferences. TRE parameters can vary within the following pre-specified and evidence-based rules shown to improve cardiometabo... | PMC10404477 | ||
Healthy eating | A registered dietitian will provide participants with a copy of Canada’s Food Guide, pre-determined nutritional education based on Canadian dietary guidelines, oncology guidelines for protein intake, individualised counselling and recommendations, and goal setting to promote healthy eating and overall nutritional well-... | PMC10404477 | ||
Sedentary time reduction | Both environmental and educational strategies will be incorporated to reduce sedentary time. Study staff will provide participants with the Canadian 24-h movement guidelines (which encompass recommendations for sedentary behaviour, physical activity and sleep), as well as education on sedentary time and the associated ... | PMC10404477 | ||
Intervention delivery | All components of the intervention will be delivered remotely by phone via evidence-based self-regulatory health behaviour support techniques | PMC10404477 | ||
Comparison group | cancer | ADVERSE EVENTS, CANCER | The comparison group will receive the current standard of cancer and supportive care at our institutions including a single group-based ‘nutrition during cancer treatment’ class, a copy of Canada’s Food Guide, the Canadian 24-h movement guidelines and a Fitbit tracker. The control group will be instructed to maintain t... | PMC10404477 |
Outcomes | metabolic syndrome | METABOLIC SYNDROME, PRESSURE AREA, INSULIN RESISTANCE | All outcomes will be measured at: (1) baseline (prior to first or second chemotherapy treatment), (2) 2–6 weeks post-last chemotherapy (typically lasting 12–18 weeks, depending on prescribed regimen) and (3) 2 years post-baseline. Participants who discontinue or deviate from intervention protocols will be asked to comp... | PMC10404477 |
Visceral adipose tissue and regional adipose tissue pools | 3T MRI (Siemens Prisma at both sites) will be used to quantify all AT volumes including the primary outcome of visceral AT. We will use standard chemical shift-encoding MRI and custom PROFIT1 | PMC10404477 | ||
Metabolic syndrome severity | Metabolic syndrome | METABOLIC SYNDROME | Metabolic syndrome will be classified according to the National Cholesterol Education Program Adult Treatment Panel III panel definition, and the severity z-score will be calculated through sex- and ethnic-specific equations | PMC10404477 |
Cardiovascular risk estimate | diabetes | CVD, HEART ATTACK, DIABETES | The Framingham 10-year CVD risk score will be calculated using the Canadian Cardiovascular Society sex-specific scoring system incorporating points for age, total cholesterol, HDL, treated/untreated systolic blood pressure, diabetes, and smoking status. The Reynolds risk score will be calculated using the same variable... | PMC10404477 |
Cardiopulmonary exercise test and resting metabolic rate | We will measure cardiorespiratory fitness by the gold standard cardiorespiratory fitness assessment, an incremental-to-maximum exercise test with open-circuit indirect calorimetry. Monitoring before, during and after the test will include heart rate, pulse oximetry, blood pressure and the Borg rating of perceived exert... | PMC10404477 | ||
Circulating biomarkers | Participants will be asked to complete an overnight water-only fast prior to venipuncture. Core laboratories at each site will analyse fasting insulin, glucose, lipid profile, hemoglobin A1c and C-reactive protein in fresh blood, while blood will be stored (in each location) at −80°C for later batch analysis of leptin,... | PMC10404477 | ||
Physical activity and sleep | A Fitbit wrist-worn tracker with heart rate monitoring will be used to collect data on average time spent performing physical activity of various intensity levels, sleep duration and quality data, and resting heart rate. | PMC10404477 | ||
Dietary intake | Dietary intake will be assessed by 3-d diet records over two consecutive weekdays and one weekend day. Each of three 24-h records will be collected using the Canadian version of the Automated Self-Administered 24-h Dietary Assessment Tool (ASA24-Canada) | PMC10404477 | ||
Questionnaires | CANCER | Chemotherapy symptom presence and severity will be assessed by the Rotterdam Symptom Checklist, which has been validated in patients with cancer | PMC10404477 | |
Medical outcomes | CVD | CVD, NON-ALCOHOLIC FATTY LIVER DISEASE, HYPERTENSION, TYPE 2 DIABETES, DYSLIPIDEMIA | We will access participant medical records to extract breast cancer diagnostic and treatment information and for chemotherapy outcomes (relative dose intensity, chemotherapy dose reductions and delays). We will also assess incident diagnoses of cardiometabolic conditions (hypertension, dyslipidemia, type 2 diabetes, CV... | PMC10404477 |
Safety outcomes | malnutrition | MALNUTRITION | We will provide all participants with a Fibit body weight smartscale at baseline to take home to measure their weight first thing in the morning at least every 3 weeks. Based on global malnutrition guidelines | PMC10404477 |
Sample size | The proposed sample size of | PMC10404477 | ||
Analyses | SECONDARY | We will evaluate for balance in baseline covariates between groups using Planned secondary analyses include a per-protocol analysis (adherence to all aspects of intervention ≥ 5 of 7 d per week), a model with adjustment for covariates with clinically or statistically significant differences between groups at baseline, ... | PMC10404477 | |
Data management | Data will be de-identified using a studyID and will be securely stored with access limited to study staff and investigators. Electronic data entry or extraction will be double-checked for accuracy. | PMC10404477 | ||
Discussion | metabolic and/or cardiovascular dysfunction, breast cancer, Metabolic toxicity, metabolic dysfunction, active cancer | SIDE EFFECT, BREAST CANCER, CVD, RECRUITMENT, EVENTS | Metabolic toxicity is an important emerging side effect from chemotherapy treatment resulting in rapid onset of metabolic dysfunction and persistent impairments after treatment completionOur intervention is designed to address potential barriers to adherence common among patients receiving active cancer treatment. For ... | PMC10404477 |
Acknowledgements | Stroke | HEART, STROKE | This trial is supported by the Canadian Institutes of Health Research. The funder will not play a role in study design, collection, management, analysis and interpretation of data. AAK and DIP are supported by the Canadian Institutes of Health Research and/or the Heart and Stroke Foundation of Canada. MJH is supported ... | PMC10404477 |
References | PMC10404477 | |||
1. Introduction | work-related injuries, sleep deficiency | VEHICLE ACCIDENT, BRADLEY, SAID | In this modern society, it is said that a significant proportion of people have problems with sleep, and sleep deprivation or sleep deficiency has become a global concern. For example, according to the Sleep Foundation [A number of previous sleep studies have shown that problems with sleep can cause serious impairments... | PMC10553342 |
Causal relationship between sleep and productivity. | presenteeism | In this paper, by introducing the concept of The contributions of this paper are as follows. First, we conducted an RCT in the general workforce to investigate the extent to which sleep health improves and work productivity improves as sleep health improves. As previous studies in sleep health have positioned presentee... | PMC10553342 | |
2. Method | PMC10553342 | |||
2–1. Randomized controlled trials | SECONDARY, RECRUITMENT | The randomized controlled trial of the sleep-improvement program analyzed in this paper was conducted among employees of a publicly traded Japanese manufacturing firm with more than 10,000 employees. The program was implemented over a six-month period from November 1, 2020, to the end of April 2021. Using a crossover R... | PMC10553342 | |
2–2. Data | For both the treatment and control groups, we used responses to self-administered surveys conducted before the start of the program (the end of October 2020; the baseline survey) and after implementation in period 1 (the end of January 2021; the follow-up survey).To measure the effect of the intervention, only the samp... | PMC10553342 | ||
Program overview. | PMC10553342 | |||
Composition of the treatment and control groups. | PMC10553342 | |||
2-2-1. Sleep-related behaviors | sleep-related behaviors, ’ behaviors | The baseline and follow-up surveys asked essentially the same nine questions about sleep-related behaviors, which were used in the analysis to examine whether the program resulted in changes in participants’ behaviors that led to improved sleep. The specific questions are indicated in S1 Table in | PMC10553342 | |
2-2-2. Sleep health measures | To test the extent to which RCTs improve sleep health, we used the following six sleep health scale items in accordance with Buysee [ | PMC10553342 | ||
Summary of the six sleep health variables. | PMC10553342 | |||
2-2-3. Productivity | We use two indices of productivity, Respondents were asked to answer each of these questions on a 10-point Likert scale, with higher numbers indicating a greater frequency. Responses to these 15 items are transformed into a composite variable, As the second productivity index, we use presenteeism data based on the As i... | PMC10553342 | ||
Basic statistics. | PMC10553342 | |||
3. Estimation strategy | PMC10553342 | |||
3–2. Two-stage least squares (2SLS) | The treatment effect (γ) of the sleep improvement program calculated in Since the estimation of In addition, note that only 58 people (approximately 40%) in the treatment group had higher posttreatment sleep satisfaction than preintervention, while 8 people (14%) in the control group reported improved sleep satisfactio... | PMC10553342 | ||
4. Estimation results | PMC10553342 | |||
4–1. Changes before and after the program | We first present simple graphs to show the extent to which sleep health improved by comparing the pretreatment and posttreatment sleep health indices of the treatment and control groups. | PMC10553342 | ||
Changes before and after the intervention. | (Notes) The graphs show the mean values of Sleep Health Scores 1 and 2 (SH1 and SH2) of 145 participants in the treatment group and 57 participants in the control group at each time point before and after the program. The larger the value on the vertical axis, the better the sleep health is ensured. The p values shown ... | PMC10553342 | ||
Effect of intervention on behavioral change in sleep. | (Notes) 1. Robust standard errors in parentheses.2. ***, **, and * indicate statistical significance at the 1%, 5%, and 10% levels.3. The variables described in section 2.2.4 are used as control variables in the estimation but are omitted from the table. | PMC10553342 | ||
4–3. Treatment effects on sleep improvement | PMC10553342 | |||
4-3-1. Effects on sleep health indices ( | Using | PMC10553342 | ||
Effect of intervention on sleep improvement. | (Notes) 1. Robust standard errors in parentheses.2. ***, **, and * indicate statistical significance at the 1%, 5%, and 10% levels.3. The variables described in section 2.2.4 are used as control variables in the estimation, but only some of them are included in the table. | PMC10553342 | ||
4-3-2. Effects on SH2 subscales | ADVERSE EFFECTS, ADVERSE EFFECT | To identify which subitems of SH2 improved through the intervention, we further estimate A statistically significant effect was confirmed for There are some other notable findings in the table. First, from the results in column 7, an increase in the number of days spent working from home may have caused the participant... | PMC10553342 | |
4–4. Treatment effects on productivity | PMC10553342 | |||
4-4-1. ATT on productivity | We next estimate Column 2 in | PMC10553342 | ||
Effect of intervention on productivity improvement (ANCOVA). | (Notes) 1. Robust standard errors in parentheses.2. ***, **, and * indicate statistical significance at the 1%, 5%, and 10% levels.3. The variables described in section 2.2.4 are used as control variables in the estimation but are omitted from the table.However, as mentioned in the previous section, the causal effects ... | PMC10553342 | ||
4-4-2. Effect of diligent efforts on productivity (2SLS) | In what follows, we use the 2SLS method to determine whether diligent participants in the sleep program improved their productivity. This estimate can be interpreted as the local average treatment effect (LATE) of diligent participation as expressed by the model, Eqs The results are shown in | PMC10553342 | ||
Effect of diligent participation on productivity (LATE). | (Notes) 1. Robust standard errors in parentheses.2. ***, **, and * indicate statistical significance at the 1%, 5%, and 10% levels.3. The variables described in section 2.2.4 are used as control variables in the estimation but are omitted from the table.4. Regarding | PMC10553342 | ||
4-4-3. Effect of sleep improvement on productivity (2SLS) | We next estimated the effect of the intervention on productivity through improvements in the sleep health indices | PMC10553342 | ||
Effect of intervention on productivity through improved sleep (2SLS). | depression, insomnia, depressed | REGRESSION | (Notes) 1. Robust standard errors in parentheses.2. ***, **, and * indicate statistical significance at the 1%, 5%, and 10% levels.3. The variables described in section 2.2.4 are used as control variables in the estimation but are omitted from the table.4. Regarding Note that the purpose of this paper is to examine the... | PMC10553342 |
4–5. Economic return to sleep improvement programs | sleep-related behaviors | In section 4–4, we measured the effects on productivity through three pathways: average effects on the treatment group, local average treatment effects of diligent participants, and indirect effects through sleep improvement. Based on those estimators, we evaluated the economic return to sleep improvement programs usin... | PMC10553342 | |
4–6. Who improved and who did not? | As mentioned in section 4–3, not all participants in the treatment group improved their sleep health through the sleep improvement program. According to previous studies, the effects and dropouts of RCTs vary according to individual characteristics, personality traits and level of education (see, for example, Bagby et ... | PMC10553342 |
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