Clinical Trial: A Complementary Approach to Late Phase II Cardiac Rehabilitation Using Wearable Devices and a Remote Cardiac Rehabilitation System: Assessing the Effectiveness of Asynchronous and Synchronous Bidirectional Monitoring (Japan)

Tokyo, Jan. 1 -- UMIN Clinical Trials Registry (UMIN-CTR) received information related to the study (UMIN000059803) titled 'Home Cardiac Rehabilitation Supported by Wearable Devices: Comparing Asynchronous and Real-Time Interactive Monitoring' on Jan. 1.

Study Type: Interventional

Study Design: Basic Design - Parallel Randomization - Randomized Blinding - Open -no one is blinded Control - Active

Primary Sponsor: Institute - Toranomon Hospital

Condition: Condition - Patients aged 20 years or older attending outpatient cardiac rehabilitation Classification by malignancy - Others Genomic information - NO

Objective: Narrative objectives1 - This study will implement an asynchronous bidirectional intervention using a wearable device and a synchronous bidirectional intervention through remote cardiac rehabilitation, and evaluate the effects of the presence or absence of intervention and differences in intervention methods on patient education and behavior change. Basic objectives2 - Efficacy

Intervention: Interventions/Control_1 - Center-based rehabilitation group undergoing standard care without educational intervention, wearing a smart ring. Interventions/Control_2 - An educational intervention involving feedback on physical activity levels measured by a smart ring and guidance to promote increased activity.

Eligibility: Age-lower limit - 20 years-old <= Age-upper limit - Not applicable Gender - Male and Female Key inclusion criteria - Patients aged 20 years or older who initiate outpatient cardiac rehabilitation with the principle of attending the clinic at least once per week. Key exclusion criteria - Patients requiring continuous monitoring

Patients with chronic or persistent atrial fibrillation

Patients undergoing dialysis

Patients deemed ineligible for study participation by the attending physician or rehabilitation physician

Patients who are not independent in activities of daily living (ADL) Target Size - 120

Recruitment Status: Recruitment status - Preinitiation Date of protocol fixation - 2026 Year 01 Month 01 Day Anticipated trial start date - 2026 Year 01 Month 05 Day Last follow-up date - 2027 Year 10 Month 30 Day

To know more, visit https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000068383

Disclaimer: Curated by HT Syndication.