Impact of online support of physical activity management using a wearable device on renal function in patients with acute coronary syndrome: a randomized controlled trial protocol

Background Acute coronary syndromes (ACS) often cause rapid decline in renal and cardiac function. In patients with ACS, combined renal dysfunction is associated with increased overall mortality and cardiovascular events. Physical activity (PA) management may crucially contribute towards protection...

Full description

Saved in:
Bibliographic Details
Main Authors: Toshimi Sato, Daisuke Suzuki, Yuichiro Sasamoto, Masahiro Ono, Namiko Shishito, Kohko Kanazawa, Akihito Watanabe, Koichi Naito, Shinichiro Morishita, Masahiro Kohzuki
Format: Article
Language:English
Published: PeerJ Inc. 2025-02-01
Series:PeerJ
Subjects:
Online Access:https://peerj.com/articles/19067.pdf
Tags: Add Tag
No Tags, Be the first to tag this record!
_version_ 1850205065562816512
author Toshimi Sato
Daisuke Suzuki
Yuichiro Sasamoto
Masahiro Ono
Namiko Shishito
Kohko Kanazawa
Akihito Watanabe
Koichi Naito
Shinichiro Morishita
Masahiro Kohzuki
author_facet Toshimi Sato
Daisuke Suzuki
Yuichiro Sasamoto
Masahiro Ono
Namiko Shishito
Kohko Kanazawa
Akihito Watanabe
Koichi Naito
Shinichiro Morishita
Masahiro Kohzuki
author_sort Toshimi Sato
collection DOAJ
description Background Acute coronary syndromes (ACS) often cause rapid decline in renal and cardiac function. In patients with ACS, combined renal dysfunction is associated with increased overall mortality and cardiovascular events. Physical activity (PA) management may crucially contribute towards protection of renal function in patients with ACS. This article describes the study protocol of a randomized controlled trial (RCT) assessing whether online support for PA management using wearable devices and information communication technology for patients with ACS facing difficulties in participating in outpatient cardiac rehabilitation after discharge can protect renal function following disease onset. Methods We have designed a two-arm RCT with a 3-month follow-up period. The online support intervention incorporates monitoring of PA, pulse rate, and blood pressure using a wearable device with an accelerometer and a web application system, as well as periodic educational feedback and goal setting. The primary study endpoint is the estimated glomerular filtration rate based on serum cystatin C (eGFRcys). The intervention effect will be assessed using the eGFRcys at 3 months adjusted for baseline values. The secondary endpoints are the urine albumin/creatinine ratio, brain natriuretic peptide levels, average step count, peak oxygen uptake, quality of life, and incidence of adverse events. Discussion This RCT will provide evidence regarding the effectiveness of online support for PA management as a renal protection strategy following ACS onset. This novel strategy not only mitigates barriers impeding participation in outpatient cardiac rehabilitation and protects cardiac and renal function in patients with ACS, but also may contribute towards improving survival and recurrence rates, preventing dialysis, and reducing medical and long-term care costs. Trial registration: The trial was registered in the Japan Registry of Clinical Trials on July 5, 2024. The registration number is jRCT1022240014 (Impact of Online Support of Physical Activity Management Using a Wearable Device on Renal Function in Patients with Acute Coronary Syndrome).
format Article
id doaj-art-8660418a0fe84cbcb3cf80accd591ceb
institution OA Journals
issn 2167-8359
language English
publishDate 2025-02-01
publisher PeerJ Inc.
record_format Article
series PeerJ
spelling doaj-art-8660418a0fe84cbcb3cf80accd591ceb2025-08-20T02:11:11ZengPeerJ Inc.PeerJ2167-83592025-02-0113e1906710.7717/peerj.19067Impact of online support of physical activity management using a wearable device on renal function in patients with acute coronary syndrome: a randomized controlled trial protocolToshimi Sato0Daisuke Suzuki1Yuichiro Sasamoto2Masahiro Ono3Namiko Shishito4Kohko Kanazawa5Akihito Watanabe6Koichi Naito7Shinichiro Morishita8Masahiro Kohzuki9Department of Physical Therapy, School of Health Sciences, Fukushima Medical University, Fukushima, JapanDepartment of Rehabilitation, Southern Tohoku General Hospital, Koriyama, JapanDepartment of Rehabilitation, Ohta Nishinouchi Hospital, Koriyama, JapanDepartment of Cardiology, Southern Tohoku General Hospital, Koriyama, JapanDepartment of Cardiology, Southern Tohoku General Hospital, Koriyama, JapanDepartment of Cardiology, Ohta Nishinouchi Hospital, Koriyama, JapanDepartment of Rehabilitation, Ohta Nishinouchi Hospital, Koriyama, JapanFaculty of Medical Science, Nagoya Women’s University, Nagoya, JapanDepartment of Physical Therapy, School of Health Sciences, Fukushima Medical University, Fukushima, JapanYamagata Prefectural University of Health Sciences, Yamagata, JapanBackground Acute coronary syndromes (ACS) often cause rapid decline in renal and cardiac function. In patients with ACS, combined renal dysfunction is associated with increased overall mortality and cardiovascular events. Physical activity (PA) management may crucially contribute towards protection of renal function in patients with ACS. This article describes the study protocol of a randomized controlled trial (RCT) assessing whether online support for PA management using wearable devices and information communication technology for patients with ACS facing difficulties in participating in outpatient cardiac rehabilitation after discharge can protect renal function following disease onset. Methods We have designed a two-arm RCT with a 3-month follow-up period. The online support intervention incorporates monitoring of PA, pulse rate, and blood pressure using a wearable device with an accelerometer and a web application system, as well as periodic educational feedback and goal setting. The primary study endpoint is the estimated glomerular filtration rate based on serum cystatin C (eGFRcys). The intervention effect will be assessed using the eGFRcys at 3 months adjusted for baseline values. The secondary endpoints are the urine albumin/creatinine ratio, brain natriuretic peptide levels, average step count, peak oxygen uptake, quality of life, and incidence of adverse events. Discussion This RCT will provide evidence regarding the effectiveness of online support for PA management as a renal protection strategy following ACS onset. This novel strategy not only mitigates barriers impeding participation in outpatient cardiac rehabilitation and protects cardiac and renal function in patients with ACS, but also may contribute towards improving survival and recurrence rates, preventing dialysis, and reducing medical and long-term care costs. Trial registration: The trial was registered in the Japan Registry of Clinical Trials on July 5, 2024. The registration number is jRCT1022240014 (Impact of Online Support of Physical Activity Management Using a Wearable Device on Renal Function in Patients with Acute Coronary Syndrome).https://peerj.com/articles/19067.pdfPhysical activityRenalAcute coronary syndromesRemote cardiac rehabilitationWearable device
spellingShingle Toshimi Sato
Daisuke Suzuki
Yuichiro Sasamoto
Masahiro Ono
Namiko Shishito
Kohko Kanazawa
Akihito Watanabe
Koichi Naito
Shinichiro Morishita
Masahiro Kohzuki
Impact of online support of physical activity management using a wearable device on renal function in patients with acute coronary syndrome: a randomized controlled trial protocol
PeerJ
Physical activity
Renal
Acute coronary syndromes
Remote cardiac rehabilitation
Wearable device
title Impact of online support of physical activity management using a wearable device on renal function in patients with acute coronary syndrome: a randomized controlled trial protocol
title_full Impact of online support of physical activity management using a wearable device on renal function in patients with acute coronary syndrome: a randomized controlled trial protocol
title_fullStr Impact of online support of physical activity management using a wearable device on renal function in patients with acute coronary syndrome: a randomized controlled trial protocol
title_full_unstemmed Impact of online support of physical activity management using a wearable device on renal function in patients with acute coronary syndrome: a randomized controlled trial protocol
title_short Impact of online support of physical activity management using a wearable device on renal function in patients with acute coronary syndrome: a randomized controlled trial protocol
title_sort impact of online support of physical activity management using a wearable device on renal function in patients with acute coronary syndrome a randomized controlled trial protocol
topic Physical activity
Renal
Acute coronary syndromes
Remote cardiac rehabilitation
Wearable device
url https://peerj.com/articles/19067.pdf
work_keys_str_mv AT toshimisato impactofonlinesupportofphysicalactivitymanagementusingawearabledeviceonrenalfunctioninpatientswithacutecoronarysyndromearandomizedcontrolledtrialprotocol
AT daisukesuzuki impactofonlinesupportofphysicalactivitymanagementusingawearabledeviceonrenalfunctioninpatientswithacutecoronarysyndromearandomizedcontrolledtrialprotocol
AT yuichirosasamoto impactofonlinesupportofphysicalactivitymanagementusingawearabledeviceonrenalfunctioninpatientswithacutecoronarysyndromearandomizedcontrolledtrialprotocol
AT masahiroono impactofonlinesupportofphysicalactivitymanagementusingawearabledeviceonrenalfunctioninpatientswithacutecoronarysyndromearandomizedcontrolledtrialprotocol
AT namikoshishito impactofonlinesupportofphysicalactivitymanagementusingawearabledeviceonrenalfunctioninpatientswithacutecoronarysyndromearandomizedcontrolledtrialprotocol
AT kohkokanazawa impactofonlinesupportofphysicalactivitymanagementusingawearabledeviceonrenalfunctioninpatientswithacutecoronarysyndromearandomizedcontrolledtrialprotocol
AT akihitowatanabe impactofonlinesupportofphysicalactivitymanagementusingawearabledeviceonrenalfunctioninpatientswithacutecoronarysyndromearandomizedcontrolledtrialprotocol
AT koichinaito impactofonlinesupportofphysicalactivitymanagementusingawearabledeviceonrenalfunctioninpatientswithacutecoronarysyndromearandomizedcontrolledtrialprotocol
AT shinichiromorishita impactofonlinesupportofphysicalactivitymanagementusingawearabledeviceonrenalfunctioninpatientswithacutecoronarysyndromearandomizedcontrolledtrialprotocol
AT masahirokohzuki impactofonlinesupportofphysicalactivitymanagementusingawearabledeviceonrenalfunctioninpatientswithacutecoronarysyndromearandomizedcontrolledtrialprotocol