Skip to content

A Randomized Controlled Trial of Asynchronous Home-based Cardiac Rehabilitation Using a Wearable Device and Smartphone Application

A Randomized Controlled Trial of Asynchronous Home-based Cardiac Rehabilitation Using a Wearable Device and Smartphone Application - A Randomized Controlled Trial of Asynchronous Home-based Cardiac Rehabilitation with Gamification (GamiHeart II study)

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
JPRN
Registry ID
JPRN-UMIN000055002
Enrollment
150
Registered
2024-09-01
Start date
2024-11-01
Completion date
Unknown
Last updated
2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Chronic Coronary Syndrome

Interventions

Asynchronous home-based cardiac rehabilitation with a smartwatch and a smartphone application Usual asynchronous home-based cardiac rehabilitation

Sponsors

St. Marianna University School of Medicine
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: Patients hospitalized for chronic coronary syndrome (coronary diseases other than acute coronary syndrome) and undergoing percutaneous coronary intervention who are 20 years of age or older and can use a smartphone and perform outdoor activities of daily living without assistance

Exclusion criteria

Exclusion criteria: 1. Patients who are unable to give their written consent 2. Patients who are unable to fill out the questionnaire on their own 3. Patients with atrial fibrillation 4. Patients who are walking with a cane or cannot walk to the hospital by themselves 5. Patients with acute myocardial infarction within 2 days of onset, untreated unstable angina, uncontrolled arrhythmia, symptomatic aortic valve stenosis, uncontrolled heart failure, acute pulmonary embolism, acute pericarditis, acute myocarditis, acute aortic dissection, patients with pacemaker/implantable cardioverter defibrillator 6. Pregnant or lactating patients 7. Patients with other serious diseases (cancer, collagen disease, etc.) who are judged by the physician in charge to be inappropriate for this study

Design outcomes

Primary

MeasureTime frame
6-minute walking distance

Secondary

MeasureTime frame
1. Change in body mass index, LDL-cholesterol, HbA1c, estimated GFR (Glomerular Filtration Rate), and (NT-pro)BNP in blood test 2. Change in Health-Related Quality of Life questionnaire (European Quality of Life 5 Dimensions 5 Level Version, EQ-5D-5L), depressive and anxiety symptoms questionnaire (Hospital Anxiety and Depression Scale, HADS) 3. Change in the visual analogue scale (0-100, with higher scores indicating greater discomfort with exercise therapy) (As for 1-3, changes are shown before and after the intervention period). 4. Correlation between the results of the Type D personality questionnaire (Type D Scale-14, DS-14) administered before intervention and the primary outcome 5. Frequency of asynchronous home-based cardiac rehabilitation 6. Frequency of new complications during the study period

Countries

Japan

Contacts

Public ContactToshiki Kaihara

St. Marianna University School of Medicine Dapartment of Cardiology

tk-presen2@marianna-u.ac.jp044-977-8111

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026