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      Clinical Feasibility of Continuously Monitored Data for Heart Rate, Physical Activity, and Sleeping by Wearable Activity Trackers in Patients with Thyrotoxicosis: Protocol for a Prospective Longitudinal Observational Study

      research-article
      , MD, MS 1 , , MD, MS 2 , , MD, PhD 2 , , MD, PhD 2 , , MD, PhD 2 , , MD, PhD 2 , , MD, PhD 3 , , MD, PhD 3 , , MD, PhD 2 , , MD, PhD 2 ,
      (Reviewer), (Reviewer), (Reviewer)
      JMIR Research Protocols
      JMIR Publications
      activity tracker, pulse rate, thyrotoxicosis, hyperthyroidism, Graves’ disease

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          Abstract

          Background

          Thyrotoxicosis is a common disease caused by an excess of thyroid hormones. The prevalence of thyrotoxicosis about 2% and 70-90% of thyrotoxicosis cases are caused by Graves' disease, an autoimmune disease, which has a high recurrence rate when treated with antithyroid drugs such as methimazole or propylthiouracil. The clinical symptoms and signs of thyrotoxicosis include palpitation, weight loss, restlessness, and difficulty sleeping. Although these clinical changes in thyrotoxicosis can be detected by currently available wearable activity trackers, there have been few trials of the clinical application of wearable devices in patients with thyrotoxicosis.

          Objective

          The aim of this study is to investigate the clinical applicability of wearable device-generated data to the management of thyrotoxicosis. We are analyzing continuously monitored data for heart rate, physical activity, and sleep in patients with thyrotoxicosis during their clinical course after treatment.

          Methods

          Thirty thyrotoxic patients and 10 control subjects were enrolled in this study at Seoul National University Bundang Hospital. Heart rate, physical activity, and sleep are being monitored using a Fitbit Charge HR or Fitbit Charge 2. Clinical data including anthropometric measures, thyroid function test, and hyperthyroidism symptom scale are recorded.

          Results

          Study enrollment began in December 2016, and the intervention and follow-up phases are ongoing. The results of the data analysis are expected to be available by September 2017.

          Conclusions

          This study will provide a foundational feasibility trial of the clinical applications of biosignal measurements to the differential diagnosis, prediction of clinical course, early detection of recurrence, and treatment in patients with thyrotoxicosis.

          Trial Registration

          ClinicalTrials.gov NCT03009357; https://clinicaltrials.gov/ct2/show/NCT03009357 (Archived by WebCite at http://www.webcitation.org/6wh4MWPm2)

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          Most cited references21

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          Graves' disease.

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            Practical guide to measuring physical activity.

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              Is Open Access

              Accuracy of Heart Rate Watches: Implications for Weight Management

              Background Wrist-worn monitors claim to provide accurate measures of heart rate and energy expenditure. People wishing to lose weight use these devices to monitor energy balance, however the accuracy of these devices to measure such parameters has not been established. Aim To determine the accuracy of four wrist-worn devices (Apple Watch, Fitbit Charge HR, Samsung Gear S and Mio Alpha) to measure heart rate and energy expenditure at rest and during exercise. Methods Twenty-two healthy volunteers (50% female; aged 24 ± 5.6 years) completed ~1-hr protocols involving supine and seated rest, walking and running on a treadmill and cycling on an ergometer. Data from the devices collected during the protocol were compared with reference methods: electrocardiography (heart rate) and indirect calorimetry (energy expenditure). Results None of the devices performed significantly better overall, however heart rate was consistently more accurate than energy expenditure across all four devices. Correlations between the devices and reference methods were moderate to strong for heart rate (0.67–0.95 [0.35 to 0.98]) and weak to strong for energy expenditure (0.16–0.86 [-0.25 to 0.95]). All devices underestimated both outcomes compared to reference methods. The percentage error for heart rate was small across the devices (range: 1–9%) but greater for energy expenditure (9–43%). Similarly, limits of agreement were considerably narrower for heart rate (ranging from -27.3 to 13.1 bpm) than energy expenditure (ranging from -266.7 to 65.7 kcals) across devices. Conclusion These devices accurately measure heart rate. However, estimates of energy expenditure are poor and would have implications for people using these devices for weight loss.
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                Author and article information

                Contributors
                Journal
                JMIR Res Protoc
                JMIR Res Protoc
                ResProt
                JMIR Research Protocols
                JMIR Publications (Toronto, Canada )
                1929-0748
                February 2018
                21 February 2018
                : 7
                : 2
                Affiliations
                [1] 1 Department of Internal Medicine, Seoul National University Healthcare System Gangnam Center Seoul Republic Of Korea
                [2] 2 Department of Internal Medicine, Seoul National University Bundang Hospital Gyeonggi-do Republic Of Korea
                [3] 3 Department of Internal Medicine, Seoul National University Hospital Seoul Republic Of Korea
                Author notes
                Corresponding Author: Jae Hoon Moon jaemoon76@ 123456gmail.com
                Article
                v7i2e49
                10.2196/resprot.8119
                5842324
                29467121
                e33989f0-0268-4fdd-86a2-21d40fcd6986
                ©Jie-Eun Lee, Dong Hwa Lee, Tae Jung Oh, Kyoung Min Kim, Sung Hee Choi, Soo Lim, Young Joo Park, Do Joon Park, Hak Chul Jang, Jae Hoon Moon. Originally published in JMIR Research Protocols (http://www.researchprotocols.org), 21.02.2018.

                This is an open-access article distributed under the terms of the Creative Commons Attribution License ( https://creativecommons.org/licenses/by/4.0/), which permits unrestricted use, distribution, and reproduction in any medium, provided the original work, first published in JMIR Research Protocols, is properly cited. The complete bibliographic information, a link to the original publication on http://www.researchprotocols.org, as well as this copyright and license information must be included.

                Categories
                Protocol
                Protocol

                activity tracker,pulse rate,thyrotoxicosis,hyperthyroidism,graves’ disease

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