Tokyo, May 18 -- UMIN Clinical Trials Registry (UMIN-CTR) received information related to the study (UMIN000061589) titled 'Effects of App-based Risk Factor Modification in Patients with Ischemic Heart Disease: A Pilot Study' on May 18.

Study Type: Interventional

Study Design: Basic Design - Single arm Randomization - Non-randomized Blinding - Open -no one is blinded Control - Historical

Primary Sponsor: Institute - Aichi Medical University

Condition: Condition - Ischemic Heart Disease Classification by malignancy - Others Genomic information - NO

Objective: Narrative objectives1 - This study aimed to evaluate the feasibility and preliminary effectiveness of a web-based remote intervention for risk factor modification in patients with ischemic heart disease Basic objectives2 - Others

Intervention: Interventions/Control_1 - This program is a 14-week program consisting of a 12-week lifestyle intervention and 5-day lifestyle assessments conducted before and after the intervention. The lifestyle assessment is conducted for 5 days using wearable devices and web-based questionnaires. Physical activity, dietary intake, blood pressure, body weight, and other parameters are measured at home and recorded through a web application. The lifestyle intervention mainly includes exercise and dietary interventions. For the exercise intervention, a target heart rate is determined based on the results of cardiopulmonary exercise testing (CPX), and participants perform exercise while self-monitoring their heart rate using a wearable device. Exercise data are transmitted to the server, and feedback is delivered through the application. In the dietary intervention, nutrients requiring improvement are identified through a web-based dietary assessment, and dietary improvement goals are established. Participants record their daily dietary intake, and feedback is provided every two weeks to support weight management and improvement of nutritional balance. Smoking cessation support is also provided for participants who request it. In addition, health information is delivered once a week to further support lifestyle improvement.

Eligibility: Age-lower limit - 20 years-old <= Age-upper limit - Not applicable Gender - Male and Female Key inclusion criteria - 1. Patients who underwent percutaneous coronary intervention (PCI) or coronary artery bypass grafting (CABG) for chronic coronary syndrome or acute coronary syndrome 2. Patients who are willing to receive remote lifestyle intervention after hospital discharge 3. Adults aged 20 years or older who are able to understand the study and provide written informed consent. Key exclusion criteria - 1. Patients who show abnormal cardiovascular responses during exercise, including ischemic ST changes, serious arrhythmias, or abnormal blood pressure responses 2. Patients with atrial fibrillation 3. Patients with left ventricular ejection fraction (LVEF) < 40% 4. Patients undergoing hemodialysis 5. Patients who are unable to use a smartphone or tablet device 6. Patients judged by physician to be unsuitable for remote lifestyle intervention 7. Patients who will participate in outpatient cardiac rehabilitation after discharge Target Size - 40

Recruitment Status: Recruitment status - Preinitiation Date of protocol fixation - 2026 Year 01 Month 05 Day Anticipated trial start date - 2026 Year 05 Month 18 Day Last follow-up date - 2027 Year 03 Month 31 Day

To know more, visit https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000070220

Disclaimer: Curated by HT Syndication.