{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,4,20]],"date-time":"2026-04-20T13:50:00Z","timestamp":1776693000476,"version":"3.51.2"},"reference-count":11,"publisher":"BMJ","issue":"9","license":[{"start":{"date-parts":[[2025,9,21]],"date-time":"2025-09-21T00:00:00Z","timestamp":1758412800000},"content-version":"unspecified","delay-in-days":20,"URL":"http:\/\/creativecommons.org\/licenses\/by-nc\/4.0\/"}],"content-domain":{"domain":["bmj.com"],"crossmark-restriction":true},"short-container-title":["BMJ Open"],"accepted":{"date-parts":[[2025,8,22]]},"published-print":{"date-parts":[[2025,9]]},"abstract":"<jats:sec>\n                  <jats:title>Introduction<\/jats:title>\n                  <jats:p>Ischaemic heart disease (IHD) is a leading cause of morbidity and mortality worldwide. Despite strong recommendations, the implementation rate of outpatient cardiac rehabilitation (CR) in Japan remains low. Mobile health technologies, such as Personal Health Record (PHR) applications combined with wearable devices, may enhance adherence to rehabilitation programmes. This study aims to evaluate the effectiveness of a continuous support programme that integrates a PHR app and counselling services in improving the continuation rate of outpatient CR and exercise tolerance in patients with IHD.<\/jats:p>\n               <\/jats:sec>\n               <jats:sec>\n                  <jats:title>Methods and analysis<\/jats:title>\n                  <jats:p>This is a single-blind randomised controlled trial with a parallel-group design. A total of 72 participants with IHD will be recruited from the outpatient departments of Maebashi Red Cross Hospital, Gunma Saiseikai Maebashi Hospital, Okayama University Hospital, Okayama Red Cross Hospital, Momoyama-kai Ono Internal Clinic, Hiroshima University Hospital, Tshuyama Jifu-kai Tsuyama Chuo Hospital and Shinpu-kai Tamashima Chuo Hospital. Participants will be randomly allocated to either the intervention group, which will receive a wearable device, a PHR app, counselling services and a rehabilitation notebook, or the control group, which will receive a wearable device and a rehabilitation notebook without the PHR app and counselling. The primary outcome is the change in peak oxygen uptake from baseline to 150 days. Secondary outcomes include changes in anaerobic threshold, number of outpatient rehabilitation visits, daily steps and vital signs. Data will be analysed using a generalised estimating equations for primary outcomes and appropriate statistical tests for secondary outcomes, following an intention-to-treat approach.<\/jats:p>\n               <\/jats:sec>\n               <jats:sec>\n                  <jats:title>Ethics and dissemination<\/jats:title>\n                  <jats:p>Ethical approval for this study was obtained from the ethics committee of the Kyoto University Graduate School and Faculty of Medicine (C1669-1). In addition, permission to conduct the study was granted by the director of each participating institution. Participants will provide informed consent prior to participation. Findings will be disseminated through peer-reviewed journals, conferences and summary reports to stakeholders.<\/jats:p>\n               <\/jats:sec>\n               <jats:sec>\n                  <jats:title>Trial registration number<\/jats:title>\n                  <jats:p>This trial is registered with the University hospital Medical Information Network (UMIN) Clinical Trials Registry (trial identifier: UMIN000055823).<\/jats:p>\n               <\/jats:sec>","DOI":"10.1136\/bmjopen-2024-095532","type":"journal-article","created":{"date-parts":[[2025,9,22]],"date-time":"2025-09-22T02:30:53Z","timestamp":1758508253000},"page":"e095532","update-policy":"https:\/\/doi.org\/10.1136\/crossmarkpolicy","source":"Crossref","is-referenced-by-count":1,"title":["Effectiveness of innovative health enhancement and cardiac rehabilitation support programme combining a personal health record app and counselling services for patients with ischaemic heart disease: a study protocol for a randomised controlled trial"],"prefix":"10.1136","volume":"15","author":[{"ORCID":"https:\/\/orcid.org\/0000-0003-3490-2101","authenticated-orcid":false,"given":"Satoshi","family":"Yoshimura","sequence":"first","affiliation":[{"name":"Department of Preventive Services, School of Public Health, Kyoto University, Kyoto, Japan"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Tomonari","family":"Shimamoto","sequence":"additional","affiliation":[{"name":"Department of Preventive Services, School of Public Health, Kyoto University, Kyoto, Japan"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Yukiko","family":"Tateyama","sequence":"additional","affiliation":[{"name":"Department of Preventive Services, School of Public Health, Kyoto University, Kyoto, Japan"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Miyuki","family":"Yazawa","sequence":"additional","affiliation":[{"name":"Saiseikai Karatsu Byoin, Karatsu, Japan"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Makoto","family":"Namba","sequence":"additional","affiliation":[{"name":"Department of Preventive Services, School of Public Health, Kyoto University, Kyoto, Japan"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"ORCID":"https:\/\/orcid.org\/0000-0001-5218-9819","authenticated-orcid":false,"given":"Norihiro","family":"Nishioka","sequence":"additional","affiliation":[{"name":"Department of Preventive Services, School of Public Health, Kyoto University, Kyoto, Japan"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Yoshimitsu","family":"Takahashi","sequence":"additional","affiliation":[{"name":"Department of Implementation Science in Public Health, School of Public Health, Kyoto University, Kyoto, Japan"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Takeo","family":"Nakayama","sequence":"additional","affiliation":[{"name":"Department of Health Informatics, School of Public Health, Kyoto University, Kyoto, Japan"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Taku","family":"Iwami","sequence":"additional","affiliation":[{"name":"Department of Preventive Services, School of Public Health, Kyoto University, Kyoto, Japan"}],"role":[{"role":"author","vocabulary":"crossref"}]}],"member":"239","published-online":{"date-parts":[[2025,9,21]]},"reference":[{"key":"2025092119300733000_15.9.e095532.1","doi-asserted-by":"crossref","first-page":"155","DOI":"10.1253\/circj.CJ-22-0234","article-title":"JCS\/JACR 2021 Guideline on Rehabilitation in Patients With Cardiovascular Disease","volume":"87","author":"Makita","year":"2022","journal-title":"Circ J"},{"key":"2025092119300733000_15.9.e095532.2","doi-asserted-by":"crossref","first-page":"1131","DOI":"10.1177\/2047487319827453","article-title":"Cardiac rehabilitation availability and delivery in Europe: How does it differ by region and compare with other high-income countries?: Endorsed by the European Association of Preventive Cardiology","volume":"26","author":"Abreu","year":"2019","journal-title":"Eur J Prev Cardiol"},{"key":"2025092119300733000_15.9.e095532.3","doi-asserted-by":"publisher","DOI":"10.1161\/CIR.0000000000001150"},{"key":"2025092119300733000_15.9.e095532.4","doi-asserted-by":"crossref","first-page":"e326","DOI":"10.1016\/S2589-7500(19)30155-4","article-title":"The evolving mHealth-based cardiac rehabilitation","volume":"1","author":"Wang","year":"2019","journal-title":"Lancet Digit Health"},{"key":"2025092119300733000_15.9.e095532.5","doi-asserted-by":"crossref","DOI":"10.1136\/bmjhci-2023-100813","article-title":"Designing and implementing mHealth technology: the challenge of meeting the needs of diverse communities","volume":"30","author":"Patel","year":"2023","journal-title":"BMJ Health Care Inform"},{"key":"2025092119300733000_15.9.e095532.6","doi-asserted-by":"crossref","unstructured":"Campagnolo Goncalves Toledo AC , Soares De Almeida N , Pierucci A , et al . The effectiveness of M-Health associated with cardiac rehabilitation on functional capacity and cardiovascular risk factors: a systematic review and meta-analysis. Eur Heart J 2021;42. doi:10.1093\/eurheartj\/ehab724.3118","DOI":"10.1093\/eurheartj\/ehab724.3118"},{"key":"2025092119300733000_15.9.e095532.7","doi-asserted-by":"crossref","DOI":"10.1001\/jamanetworkopen.2024.53499","article-title":"Rehabilitation at Home Using Mobile Health for Older Adults Hospitalized for Ischemic Heart Disease: The RESILIENT Randomized Clinical Trial","volume":"8","author":"Dodson","year":"2025","journal-title":"JAMA Netw Open"},{"key":"2025092119300733000_15.9.e095532.8","doi-asserted-by":"crossref","DOI":"10.1016\/j.cmpb.2024.108551","article-title":"M-health with cardiac rehabilitation improves functional capacity: A systematic review with meta-analysis","volume":"260","author":"Pierucci","year":"2025","journal-title":"Comput Methods Programs Biomed"},{"key":"2025092119300733000_15.9.e095532.9","doi-asserted-by":"publisher","DOI":"10.1001\/jama.2009.681"},{"key":"2025092119300733000_15.9.e095532.10","doi-asserted-by":"publisher","DOI":"10.1016\/j.ahj.2009.10.003"},{"key":"2025092119300733000_15.9.e095532.11","doi-asserted-by":"crossref","DOI":"10.7717\/peerj.3268","article-title":"Barriers to the use of personal health records by patients: a structured review","volume":"5","author":"Showell","year":"2017","journal-title":"PeerJ"}],"container-title":["BMJ Open"],"original-title":[],"language":"en","link":[{"URL":"https:\/\/syndication.highwire.org\/content\/doi\/10.1136\/bmjopen-2024-095532","content-type":"unspecified","content-version":"vor","intended-application":"similarity-checking"}],"deposited":{"date-parts":[[2025,9,22]],"date-time":"2025-09-22T02:30:57Z","timestamp":1758508257000},"score":1,"resource":{"primary":{"URL":"https:\/\/bmjopen.bmj.com\/lookup\/doi\/10.1136\/bmjopen-2024-095532"}},"subtitle":[],"short-title":[],"issued":{"date-parts":[[2025,9]]},"references-count":11,"journal-issue":{"issue":"9","published-online":{"date-parts":[[2025,9,21]]},"published-print":{"date-parts":[[2025,9]]}},"alternative-id":["10.1136\/bmjopen-2024-095532"],"URL":"https:\/\/doi.org\/10.1136\/bmjopen-2024-095532","relation":{},"ISSN":["2044-6055","2044-6055"],"issn-type":[{"value":"2044-6055","type":"print"},{"value":"2044-6055","type":"electronic"}],"subject":[],"published":{"date-parts":[[2025,9]]}}}