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Background: Physical activity has been shown to have a positive impact on cystic fibrosis (CF) symptoms and slows decline in lung function. Additionally, moderate-intensity activities have been shown to improve sputum expectoration and oxygen saturation in children with CF, improving symptoms [1]. This study assessed whether using fitness trackers and providing a daily step goal would increase physical activity in hospitalized children with CF. Method(s): This pre-post pilot study included participants aged 6 to 21 who were admitted to the hospital for a pulmonary exacerbation of CF between October 2020 and November 2021. Garmin vivosmart 4 wrist-based activity trackers were issued, and baseline datawere tracked and analyzed for the first 2 study days. Pre-goal number of steps was defined as average number of steps taken on those 2 days. On study day 3, a step goal and menu of activities designed to increase physical activity were shared with the participants. Steps after goal settingwere defined as average number of steps taken on study day 3 and beyond while hospitalized, excluding day of discharge. Data collected from the medical record and the activity tracker web-based profile included daily oxygen requirement, daily step count, sleep duration, overnight pulse oximetry levels, resting heart rate, calories expended, and intensity minutes. The primary outcome of change in daily steps and attainment of step goals was analyzed using descriptive statistical testing, means, and standard deviations. Outpatient data were collected for 3 months to observe adherence to goals after discharge. Result(s): Eight participants aged 6 to 18 completed the study. Hospital length of stay ranged from 4 to 14 days. Participants took an average of 1508 +/- 1078 steps before goal setting, which increased to an average of 3704 +/- 1555 steps after the intervention. Step goals were met 56% of the time, although these data were highly variable. During the first week after hospital discharge, participants took an average of 6303 +/- 1786 steps per day (Figure 1).(Figure Presented) Figure 1. During the intervention, patients met their step goal 56% of the time, although this was highly variable. Two patients met their goal 100% of the time (9- year-old boy, 7-year-old girl), two met it 0% of the time (18-year-old boy, 17-year-old girl), one met it 44% of the time (6-year-old boy), and the remaining three met it 67% of the time (10-year-old girl, 17-year-old girl, 14-year-old boy). Conclusion(s): This intervention shows promise, with daily number of steps doubling from baseline during the intervention period. There was great variability among participants, suggesting that the approach helps some more than others. Enrollment was initially planned for 20 patients, but the SARS-CoV-2 pandemic and changes to CF therapy reduced hospitalizations during the study period. Outpatient data were analyzed for only the first week after discharge because of poor adherence to wearing the device. Although our results showa positive impact, further research is needed to determine the effect such an intervention would have on a larger scale. Future directions of research include determining potential clinical benefit from increased activity during hospitalization and prolonged follow-up to assess long-term benefits of intervention.Copyright © 2022, European Cystic Fibrosis Society. All rights reserved
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Background: Due, partially, to the COVID-19 pandemic, interest in remote clinical trials has grown rapidly. The convenience associated with remote trials, for both researchers and participants, can lead to improved recruitment, retention, and engagement. Advancements in digital technology have led to increased accessibility to remote healthcare and have made possible remote data collection and intervention delivery in clinical trials. However, remote clinical trials are not ''one-sizefits- all'' and present key challenges, particularly, when there are multi-component outcomes, for example, the metabolic syndrome (MetS). Motivated by an ongoing, in-person, national, multi-site clinical trial aimed at the remission of the MetS (ELM trial), the Virtual ELM pilot study assessed the plausibility of remote data collection and delivery of a lifestyle intervention to participants with the MetS. It focused on weight loss after a 3-month treatment, which was used as a surrogate measure for the MetS. Objective(s): To assess the feasibility and remediate challenges of a fully remote data collection and intervention delivery for translation into a large-scale remote clinical trial. Method(s): A treatment-only pilot study was conducted with 10 participants with the MetS. Participants were recruited via self-referral or medical records interrogation. They attended virtual group meetings via Zoom led by trained interventionists every week for three consecutive months to practice mindful exercise and eating. Intervention tools, such as participant selfmonitoring, included daily food intake, mindful habit logs and daily steps. All data collection was completed remotely including weight and components of the MetS (waist circumference, blood pressure, glucose, HDL, and triglycerides). Other outcomes included physical activity, diet, and mindfulness. Remote data collection was conducted using a variety of tools including Snap Surveys (web-based questionnaires), Actigraph/ CentrePoint (accelerometer-based physical activity), Fitabase (weight, steps, and food logs). Accelerometers, blood pressure monitors, Fitbit activity trackers, wireless scales, and waist measuring tapes were mailed to participants, along with instructions on how to use them. Participants visited Quest Diagnostics to complete blood draws. Result(s): There were several challenges such as remote recruitment, outcomes data collection, and intervention delivery. The most distinctive challenges were completion of the accelerometer and blood draw protocols. Despite the challenges, this pilot achieved 100% retention for both baseline and follow-up outcomes assessments and 95% remote session attendance. Thirty percent of the sample achieved remission of MetS and 40% achieved weight loss >=5%. The screening-toenrollment ratio was 2.0. Conclusion(s): The Virtual ELM pilot study showed promising results for the possibility of efficient execution of a remote, large-scale trial. The study helped identify challenges associated with its virtual nature, such as physical measures and physical activity protocol completion, and resourceful delivery of the intervention content. Proactively addressing challenges in the enrollment phase, for example, screening for smartphone technology awareness and refinement in the planning phase, for example, selecting effective data capture tools, is essential for a successful, remote trial.
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Background: Supervised exercise programs (SEP) have demonstrated an improvement in quality of life (QoL), cardiovascular health, treatment tolerance and disease outcomes in early breast cancer patients. In metastatic breast cancer (MBC), previous data suggest SEP are safe but no impact on QoL and a low adherence to programs were shown. These studies included a heterogenous population in terms of type of treatments received, numbers of previous lines or comorbidities. From our perspective, MBC profile that could benefit most from SEP needs to be explored. Thus, we conducted a pilot study to assess adherence, safety and impact on QoL of a combined SEP and nutritional program (NP) in a selected population of MBC of patients treated with cyclin-dependent kinase 4/6 inhibitors (iCDK 4/6). Method(s): This is a prospective, single center, single arm pilot study. SEP consisted in a 12-week intervention with twice a week in-person resistance exercise session. Patients also completed weekly aerobic exercise goals in self-managed sessions monitored with activity trackers. SEP was conducted by registered Physical Activity and Sports Science instructors that followed American College of Sports Medicine guidelines. In addition, participants had an initial nutritional assessment and personalized counselling by a qualified nutritionist. Adherence to treatment, biological variables and QoL assessments (FACIT-Fatigue and QLQ-C30 questionnaires) were collected at baseline (B) and week-12 (w12). Primary endpoint was global adherence (>=70% of attended sessions relative to scheduled sessions). Secondary endpoints included safety, changes in biological variables and QoL. Paired samples t-tests (Wilcoxon) were used to assess biological changes and QoL. Result(s): Patients (n=26) were recruited from October 2020 to November 2021. Median age was 47,5 years (45-55);84,6% of patients were ECOG 0. 42,3% of patients were receiving Abemaciclib;34,6% Ribociclib and 23,1% Palbociclib in first (73,1%) or second (26,9%) line treatment. Patients had bone (69,2%);visceral metastasis (57,7%) or both (30,8%). 2 patients did not start the intervention and additional 7 patients discontinued the program prematurely, the majority of them due to COVID-related concerns. Considering all patients who at least attended one session, global adherence was 66% (39-77,5%) and 45,8% of patients achieved an adherence of >= 70%. Patients reported an improvement in QoL [B global QLQ-C30 66,6 (50-75), w12 75 (66,6-83,3);p 0,0121] and fatigue [B FACIT-Fatigue 37 (30-44), w12 42 (38-48);p 0,0017]. Sit-to-stand repetitions in 30-second period also improved [(B 15 (12-17), 19 (15-23);p 0,0002]. Same benefits were seen in patients with adherence >= 70%. No statistically significant changes were seen in body fat or muscular composition and handgrip scores. Importantly, no safety issues related to study intervention were reported. Conclusion(s): Even though the study was conducted during COVID-19 pandemic, global adherence was 66%. For the first time in MBC, SEP and NP combined program demonstrated to be safe and improved QoL in patients with first or second line MBC treated with iCDK4/6. Further research is needed to identify strategies that improve QoL in MBC.
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Introduction: Following the trend of digital health applications, implemented especially during the COVID-19 pandemic, the ENDORSE project, is designed as an innovative integrated platform for supporting clinical decision making and telemedicine in children with Type 1 Diabetes Mellitus (T1DM), utilizing explainable artificial intelligence along with gamification and mobile technologies. Objective(s): Assessment of preliminary data from the prepilot phase of the ENDORSE feasibility trial. Method(s): ENDORSE platform utilizes various data sources such as glucose sensors (Flash Glucose Monitoring-FGM), smart insulin pen caps, activity trackers, mobile apps, Electronic Health Records and a newly developed serious game. A 13 T1DM children and adolescents (8 females, on multiple daily injections, mean diabetes duration 2, 57 years, mean HbA1c 7, 6%, mean Body Mass Index +1, 2 SDS, mean monitoring days: 151), followed in our Diabetes Center, were assessed regarding adherence to the study protocol. They all had internet access and only one has used a diabetes mobile application before. Result(s): As shown in Table 1, most of the patients used the Smart Insulin Pen Cap to document insulin and food data and many performed mobile FGM scanning, while the engagement to the ENDORSE serious game, aiming at training in self-disease management, along with the activity trackers is highly variable. Conclusion(s): ENDORSE platform along with changes in daily diabetes care practices like CGM usage, is expected to improve diabetes management through facilitating training, monitoring and feedback to the patients and their caregivers. In order to further improve its adherence and acceptance, factors such as the level of digital literacy and the need of a personalized experience to improve usability, should be also taken into consideration.
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Aims: Assess the implementation of a telehealth supervised group exercise (tele-exercise) program for patients with cancer, using the RE-AIM framework (Reach, Effectiveness, Adoption, Implementation, Maintenance). Method(s): Cancer patients with medical clearance and access to home internet participated in a physiotherapy-led tele-exercise program, comprising twice-weekly sessions for 12 weeks and featuring aerobic, resistance and balance exercises. A Garmin activity tracker was worn during sessions. Subjective (fatigue, quality of life) and objective (muscle strength, cardiorespiratory fitness, balance) measures were taken pre and post-program. Qualitative interviews (analysed using thematic and content analyses) and an online survey were completed post-program. Result(s): Reach: Twenty-six eligible participants consented and were enrolled. Twenty-four commenced the program, most of whom were female (92%), diagnosed with breast cancer (75%), treated with surgery (96%), chemotherapy (88%) or radiation therapy (54%). Effectiveness: FACIT-F scores indicated reduced fatigue (mean difference 5.8 [95% CI 1.9-9.8], p < 0.01). Improvements were seen across several strength, fitness and balance outcomes (e.g. upper body strength +5.6 [2.6-8.6] kg, p < 0.01). There were no changes to quality of life (FACT-G). Adoption: Participants found classes easy to integrate into daily routines and felt it helped avoid negative aspects of in-person exercise (e.g. COVID-19 exposure, parking). Recruitment improved after introducing a 6:30 am class. Most (78%) participants felt very confident using the technology. Viewing heart rate via the Garmin device contributed to feeling safe whilst exercising. Implementation: 21 of 24 participants completed the program. Mean number of sessions attended was 22. Maintenance: Participants suggested feasible improvements to program orientation, discharge, and the exercise classes. All felt comfortable using the internet for tele-exercise. The majority considered a telehealth class as equal to an in-person class (15 of 18, 83%). Conclusion(s): A telehealth group exercise program for people with cancer was successfully implemented. Further information is needed regarding non-breast cancer patients and non-tertiary hospital settings.
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ObjectivesTo investigate whether and how PA tracker application use supports PA behavior among older adults during the first 24 months of use. Methods: The changes in PA levels (i.e., time spent in different PA intensities) and between PA categories (i.e., low, moderate, or high based on total PA) were examined between three different time points: before taking the application into use (t0), after 12 months of use (t1), and after 24 months of use (t2). The data was collected by using the International Physical Activity Questionnaire modified for the elderly (IPAQ-E). Results: A statistically significant increase was observed in walking (χ2 (2) = 29.741, p < .001), moderate PA (χ2 (2) = 6.327, p = .042), and total PA levels (χ2 (2) = 11.489, p = .003). The increase was observed between t0 and t1 as well as between t0 and t2. The overall changes between PA categories were statistically significant between t0 and t1 (χ2 (3) = 15.789, p = .001) as well as between t0 and t2 (χ2 (3) = 14.745, p = .002). There were more increasingly active (moved to a higher PA category) than decreasingly active (moved to a lower PA category) participants. Discussion: Overall, the results indicate that PA tracker application use can promote PA behavior among older adults. Stakeholders that work with PA programs and PA promotion, as well as individual users, can utilize digital wellness technologies in supporting PA promotion, especially in exceptional times, like the COVID-19 pandemic, when health care restrictions prevent general gatherings.
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With years of experience in rehabilitation program for CF patients, we note that, despite a good adherence to APA during the stays, patients do not maintain a recommended level of PAwhen they return home.We therefore set up the "CoachMois challenge", with the objective of a follow-up at home, maintaining motivation, social interactions (reduced during lockdowns) and the skills learned in rehabilitation programs. Four challenges are offered per year: 2 during spring (based on walking) and 2 during winter (based on PA at home). For each challenge, 8 to 10 patients can choose to have someone from their entourage participate. Two healthcare professionals working with patients can also participate. Patients can benefit from a fitness tracker to record their activities. The first year of the "CoachMois challenge"was only for patients from the Roscoff CF Centre. To meet growing demand, we have opened the challenge to patients from other CF Centres since November 2021 (provided to those who have already participated in a rehabilitation program at Roscoff CF Centre). Challenges are collective but individualised, and take place via Facebook when the patient is at home. The aim is to increase the level of daily PA by following a fun collective goal, and sharing challenges, tips, and live video sessions with a Roscoff PA Educator. The challenge is based on the "fun theory" (all information is much better integrated when transmitted with humor). Since July 2019, 4 challenges were organised. Because of COVID- 19, we were unable to propose any challenges in 2020. We also had to change the way we practice. We started again in June 2021. Thirty-two patients participated, 12 “carers” and 8 professionals. Evaluation questionnaires are given to patients at the end of each challenge: qualitative analysis is in progress.We would like to work on inter-CF-centre challenges with participation of our PA Educator colleagues.We could also extend the experience to other chronic diseases.
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BACKGROUND: Wearables refer to devices that are worn by individuals. In the health care field, wearables may assist with individual monitoring and diagnosis. In fact, the potential for wearable technology to assist with health care has received recognition from health systems around the world, including a place in the strategic Long Term Plan shared by the National Health Service in England. However, wearables are not limited to specialist medical devices used by patients. Leading technology companies, including Apple, have been exploring the capabilities of wearable health technology for health-conscious consumers. Despite advancements in wearable health technology, research is yet to be conducted on wearables and empowerment. OBJECTIVE: This study aimed to identify, summarize, and synthesize knowledge on how wearable health technology can empower individuals to take greater responsibility for their health and care. METHODS: This study was a scoping review with thematic analysis and narrative synthesis. Relevant guidance, such as the Arksey and O'Malley framework, was followed. In addition to searching gray literature, we searched MEDLINE, EMBASE, PsycINFO, HMIC, and Cochrane Library. Studies were included based on the following selection criteria: publication in English, publication in Europe or the United States, focus on wearables, relevance to the research, and the availability of the full text. RESULTS: After identifying 1585 unique records and excluding papers based on the selection criteria, 20 studies were included in the review. On analysis of these 20 studies, 3 main themes emerged: the potential barriers to using wearables, the role of providers and the benefits to providers from promoting the use of wearables, and how wearables can drive behavior change. CONCLUSIONS: Considerable literature findings suggest that wearables can empower individuals by assisting with diagnosis, behavior change, and self-monitoring. However, greater adoption of wearables and engagement with wearable devices depend on various factors, including promotion and support from providers to encourage uptake; increased short-term investment to upskill staff, especially in the area of data analysis; and overcoming the barriers to use, particularly by improving device accuracy. Acting on these suggestions will require investment and constructive input from key stakeholders, namely users, health care professionals, and designers of the technology. As advancements in technology to make wearables viable health care devices have only come about recently, further studies will be important for measuring the effectiveness of wearables in empowering individuals. The investigation of user outcomes through large-scale studies would also be beneficial. Nevertheless, a significant challenge will be in the publication of research to keep pace with rapid developments related to wearable health technology.
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State Medicine , Wearable Electronic Devices , Biomedical Technology , Data Collection , Forecasting , HumansABSTRACT
BACKGROUND: Physical activity (PA) during pregnancy is an effective and safe way to improve maternal health in uncomplicated pregnancies. However, compliance with PA recommendations remains low among pregnant women. OBJECTIVE: The purpose of this study was to evaluate the effects of offering structured supervised exercise training (EXE) or motivational counseling on PA (MOT) during pregnancy on moderate-to-vigorous intensity physical activity (MVPA) level. Additionally, complementary measures of PA using the Pregnancy Physical Activity Questionnaire (PPAQ) and gold standard doubly labeled water (DLW) technique were investigated. The hypotheses were that both EXE and MOT would increase MVPA in pregnancy compared with standard care (CON) and that EXE would be more effective than MOT. In addition, the association between MVPA and the number of sessions attended was explored. METHODS: A randomized controlled trial included 220 healthy, inactive pregnant women with a median gestational age of 12.9 (IQR 9.4-13.9) weeks. A total of 219 women were randomized to CON (45/219), EXE (87/219), or MOT (87/219). The primary outcome was MVPA (minutes per week) from randomization to the 29th gestational week obtained by a wrist-worn commercial activity tracker (Vivosport, Garmin International). PA was measured by the activity tracker throughout pregnancy, PPAQ, and DLW. The primary outcome analysis was performed as an analysis of covariance model adjusting for baseline PA. RESULTS: The average MVPA (minutes per week) from randomization to the 29th gestational week was 33 (95% CI 18 to 47) in CON, 50 (95% CI 39 to 60) in EXE, and 40 (95% CI 30 to 51) in MOT. When adjusted for baseline MVPA, participants in EXE performed 20 (95% CI 4 to 36) minutes per week more MVPA than participants in CON (P=.02). MOT was not more effective than CON; EXE and MOT also did not differ. MVPA was positively associated with the number of exercise sessions attended in EXE from randomization to delivery (P=.04). Attendance was higher for online (due to COVID-19 restrictions) compared with physical exercise training (P=.03). Adverse events and serious adverse events did not differ between groups. CONCLUSIONS: Offering EXE was more effective than CON to increase MVPA among pregnant women, whereas offering MOT was not. MVPA in the intervention groups did not reach the recommended level in pregnancy. Changing the intervention to online due to COVID-19 restrictions did not affect MVPA level but increased exercise participation. TRIAL REGISTRATION: ClinicalTrials.gov NCT03679130; https://clinicaltrials.gov/ct2/show/NCT03679130. INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): RR2-10.1136/bmjopen-2020-043671.
Subject(s)
COVID-19 , Pregnant Women , COVID-19/prevention & control , Counseling , Exercise/psychology , Female , Humans , Infant , PregnancyABSTRACT
Background: As COVID-19 pandemic continues, using technologies within cardiac rehabilitation facilitates access to care and reduces the frequency of direct contact with vulnerable cardiac patients. We aimed to assess the feasibility of technology-assisted interventions in hybrid cardiac rehabilitation (TecHCR) and preliminarily evaluate its effects on patients with coronary heart disease (CHD). Methods: Between February 2021 to May 2021, a total of 28 patients with CHD were recruited and randomised to receive a 12-week TecHCR programme (n = 14) or a 12-week conventional, centre-based programme (n = 14). The TecHCR group received three center-based, supervised exercise training sessions. Participants were instructed to wear a fitness tracker watch for exercise self-monitoring at home environment, and the exercise data were shared through a web-based application for remote monitoring by the intervener. Participants received six audio-visual educational videos via a messaging application and a weekly video/telephone call follow-up. Self- Efficacy for Exercise (ESE), Health Promoting Lifestyle Profile II (HPLP II), Hospital Anxiety and Depression Scale (HADS), exercise capacity and cardiovascular health outcomes were assessed at baseline and at 12th week on completion of the programme. Generalised estimating equations analysis was conducted to compare the outcomes between groups. Results: Out of 28 participants (56.46±12.98 years old;1 female), 67.9% had percutaneous coronary intervention and 28.6% had coronary bypass grafting surgery. Among 14 participants in the TecHCR group, three dropped out due to: 1) fear to attend face-to-face supervised exercise training during high daily COVID-19 cases;2) infected with COVID-19 and 3) found a job in overseas. Eleven participants in the TecHCR group attended all video/telephone call sessions, nine participants completed 3 supervised exercise training sessions and nine participants adhered to the weekly exercise recommendations. No treatment-related adverse events were reported. TecHCR was non-inferior to conventional, centre-based program on exercise self-efficacy, exercise capacity and cardiovascular health outcomes. TecHCR group showed significantly greater improvement in health-promoting behavior when compared with the control group (p =0.013) at post-intervention. Conclusion: This pilot study demonstrated the feasibility in recruitment and implementation of TecHCR as an alternative delivery mode and could enhance health-promoting behavior among patients with CHD. Implications: The TecHCR program provides accessible interventions to patients without frequent visits to the outpatient centre. A full-scale randomised controlled trial is needed to confirm the effectiveness of TecHCR.
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Background and Aims: Following the trend of digital health applications, implemented especially during the COVID-19 pandemic, the Greek funded project, named ''ENDORSE'', is designed as an innovative integrated platform for supporting clinical decision making and telemedicine in children with Type 1 Diabetes Mellitus (T1DM), harnessing the power of explainable artificial intelligence along with gamification and mobile technologies. Methods: ENDORSE platform utilizes various data sources such as glucose sensors, smart insulin pens, activity trackers, mobile apps, Electronic Health Records and serious games. A two-phase pilot trial is foreseen to evaluate its effectiveness. In the pre-pilot phase, 14 T1DM children and adolescents followed in the Diabetes Center (Table 1) were enrolled and preliminary data regarding patients' adherence, are presented. Results: As shown in Table 2, most of the patients were able to regularly perform FGM scanning through mobile phones while the engagement to the ENDORSE serious game, aiming at training in self-disease management, along with the activity trackers is highly variable. Conclusions: ENDORSE platform along with changes in daily diabetes care practices like CGM usage, is expected to improve diabetes management through facilitating training, monitoring and feedback to the patients and their caregivers. In order to further improve ENDORSE's adherence and acceptance, factors such as the level of digital literacy and internet access should be also taken into consideration.
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Purpose of Study Cystic Fibrosis (CF) is a progressive, genetic disease that affects over 30,000 individuals across the nation and results in decreased functionality of the lungs. Physical activity has a positive impact on the symptoms of CF and works to slow the decline in lung function. Additionally, activities with moderate intensity have been shown to improve sputum expectoration and oxygen saturation in children with CF. This study assessed whether using fitness trackers and providing a daily step goal would increase physical activity in hospitalized children and young adults with CF. Methods Used This prospective study included participants 6- 21 years of age who were admitted to the hospital for a pulmonary exacerbation of CF between October 2020-May 2021. Study enrollment occurred no more than 48 hours after hospital admission. Garmin vivosmart® 4 wrist-based activity trackers were issued and baseline data were tracked and analyzed for the first 2 study days. Pre-goal steps were defined as the average of steps taken on those 2 days. On study day 3, a step goal and menu of activities designed to increase physical activity were shared with the participant. Steps after goal setting were defined as the average of steps taken on study day 3 and beyond, excluding day of discharge. Data were collected from the electronic medical record and the activity tracker web-based profile and included the following: daily oxygen requirement, daily step count, sleep duration, overnight pulse oximetry levels, resting heart rate, calories expended, and intensity minutes. The primary outcome of change in daily steps and attainment of step goals was analyzed using descriptive statistical testing, means and standard deviations. Summary of Results Six patients, aged 6-18 years, completed the study. Mean baseline FEV1for study participants was 66% predicted (range 38 to 92%). Hospital length of stay ranged from 4-14 days. Participants took an average of 1772 ± 1011 steps before goal setting. This increased to an average of 3741 ± 1780 steps after goal setting. Overall, step goals were met 52% (Range 0-100%) of the time. Conclusions This intervention shows promise, as daily steps doubled from baseline during the intervention period. There was great variability among the participants, suggesting the device may help some people much more than others. Enrollment was initially planned for 20 patients;however, the SARS-CoV-2 pandemic and consequent changes to CF therapy drastically reduced hospitalizations during the study period. Though our results show a positive impact of increased physical activity following goal implementation, further research is needed to determine the effect such an intervention would have on a larger scale. Future directions of research include having a larger sample size, conducting a multi-center study to increase population diversity, and implementing a longer follow- up period to better assess long term benefits of intervention.
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With the growth of aging societies, the health of the elderly is considered one of the critical issues. Regular physical activity is linked to improving physical and mental functions. Therefore, there is an urgent need to motivate the elderly to be physically active. The self-monitoring of physical activity may positively impact the awareness of exercise and health and increase activity levels. In this study, we conducted a 12-week trial with thirty Japanese elderly to investigate the effects of self-monitoring on their attitudes, awareness, and activity levels. During the trial, the participants wore activity trackers daily and responded to repeated questionnaires weekly. The Covid-19 pandemic has begun to appear a few weeks after starting this trial. Therefore, we explored the impact of this pandemic on the participants' activity and psychological status. Overall, the participants increased their perception of the benefits of self-monitoring and willingness to check the activity tracker's feedback. Despite there was a significant decrease (p < 0.05) in the participant number of steps due to the Covid-19 pandemic, the percentage of reduction was small (11%). The self-monitoring of activity may help the elderly maintain activity level during the pandemic. Furthermore, the participants agreed with the importance of monitoring physical activity and the necessity to maintain activity level during the Covid-19 pandemic. © 2021 Association for Computing Machinery. All rights reserved.
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Background: Given the current physical isolation and distancing measures in place as a result of the COVID- 19 pandemic, and the health risks associated with leaving one's home, cancer patients face new and unprecedented challenges in connecting with their communities and conducting activities of daily living. They are also experiencing changes in their treatment and medical follow-up plans. Consequently, they are at even greater risk of experiencing loneliness, anxiety, depression, and reduced quality of life compared to the general population. There is emerging evidence for the use of mobile health applications to improve social connections, engage patients in their own health, and provide psychosocial support among cancer survivors. Thus, we are conducting the COMPANION study to examine the use of a mobile health application, Elly, to reduce levels of anxiety, stress, and feelings of social isolation and loneliness as a result of isolation during the COVID-19 pandemic among cancer patients and survivors (NCT04604158). Methods: This is a prospective, interventional study of patients who self-identify as currently receiving cancer-targeted treatment. All study recruitment and consent procedures, assessments, and follow-up are completed remotely using REDCap. Participants are given access to the Elly phone application developed by Elly Health Inc. and followed for 6 months. Elly is a multi-platform mobile solution that enables cancer patients to receive support and assistance in the management of their illness. Elly delivers audio content through a mobile app to comfort, inspire and motivate its users including tools to manage their diagnosis and symptoms including interactive sessions on motivation, unspoken (taboo topics), exercise, mindfulness, sleep, nutrition, self-care, and symptom as well as COVID-19 specific topics. Results: The COMPANION trial is currently open to accrual. Approximately 100 patients will be enrolled between November 2020 and December 2021. Trial design and protocol development, regulatory activities including submission to the local ethics review board, and communication was completed remotely and included an interdisciplinary team of clinical trialists, behavioral scientists, oncologists, and psychiatrists. This study provides an example of how clinical trials may be developed and managed in a decentralized manner and under budget and time constraints. Surveys will be administered through REDCap at baseline and monthly thereafter to assess the patient's social status, medical history (including history of COVID-19), and National Institutes of Health PROMIS anxiety, depression, perceived stress, pain, loneliness, social support, and global health scales. Participants may opt to wear and link activity trackers in order to obtain objective measures of daily activity. Patients will also have the option to consent to the optional qualitative interview sub-study. Conclusion: Using COMPANION as a case example, we demonstrate the feasibility of designing and conducting a trial to monitor patient outcomes and deliver a mobile health intervention in a remote setting. Findings from this work will provide fundamental knowledge of the additional impact COVID-19 has had on cancer patients' anxiety, depression, and stress levels. This study will also improve our understanding of the short- and long-term effects of COVID-19 and how it's trajectory over the course of the next 6 months and beyond will impact these outcomes.
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The fight against COVID-19 is hindered by similarly presenting viral infections that may confound detection and monitoring. We examined person-generated health data (PGHD), consisting of survey and commercial wearable data from individuals' everyday lives, for 230 people who reported a COVID-19 diagnosis between March 30, 2020, and April 27, 2020 (n = 41 with wearable data). Compared with self-reported diagnosed flu cases from the same time frame (n = 426, 85 with wearable data) or pre-pandemic (n = 6,270, 1,265 with wearable data), COVID-19 patients reported a distinct symptom constellation that lasted longer (median of 12 versus 9 and 7 days, respectively) and peaked later after illness onset. Wearable data showed significant changes in daily steps and prevalence of anomalous resting heart rate measurements, of similar magnitudes for both the flu and COVID-19 cohorts. Our findings highlight the need to include flu comparator arms when evaluating PGHD applications aimed to be highly specific for COVID-19.
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AIMS: Coronavirus disease (Covid-19) could lead persons with pre-existing medical conditions to severe respiratory infections. The Italian Government introduced quarantine to limit viral transmission. This measure could lead people with type 1 diabetes (PWT1D) to disrupt daily care routine including PA practice with difficulties in glycemia management. This study aims to explore PA level in PWT1D before and during quarantine and to describe variation in glycemia values. METHODS: An online survey investigating medical factors and the perceived and PA level in pre-established period before and after the introduction of quarantine was developed. Comparison between pre and post quarantine was assessed by Wilcoxon Signed Ranks test for continuous variables. RESULTS: A total of 154 subjects satisfied the eligibility criteria (54.5% males, 44.8 ± 12.5 years). We found a decrease of PA level (Godin Scale Score 25 ± 1.7vs38.6 ± 1.7 points), steps number and minutes of exercise (respectively 12.606 ± 5026vs4.760 ± 3.145 and 66±4 vs 38±3) and an increase of glycemia values (142.1 ± 25.4 mg/dLvs150.8 ± 29.4 mg/dL). CONCLUSIONS: PWT1D reported a decrease in exercise and worst glycemia. Although PWT1D tried to remain active, their PA level was inadequate to prevent glycemia rising. The difficult to maintain a glycemic control could expose patients to diabetes complications and to an higher risk to counteract infections.