UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000055002 |
|---|---|
| Receipt number | R000062838 |
| Scientific Title | A Randomized Controlled Trial of Asynchronous Home-based Cardiac Rehabilitation Using a Wearable Device and Smartphone Application |
| Date of disclosure of the study information | 2024/09/01 |
| Last modified on | 2025/07/18 12:13:17 |
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Basic information
Public title
A Randomized Controlled Trial of Asynchronous Home-based Cardiac Rehabilitation Using a Wearable Device and Smartphone Application
Acronym
A Randomized Controlled Trial of Asynchronous Home-based Cardiac Rehabilitation with Gamification (GamiHeart II study)
Scientific Title
A Randomized Controlled Trial of Asynchronous Home-based Cardiac Rehabilitation Using a Wearable Device and Smartphone Application
Scientific Title:Acronym
A Randomized Controlled Trial of Asynchronous Home-based Cardiac Rehabilitation with Gamification (GamiHeart II study)
Region
| Japan |
Condition
Condition
Chronic Coronary Syndrome
Classification by specialty
| Cardiology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To verify whether a wearable device (smartwatch) and a smartphone application with gamification elements can be effective for asynchronous home-based cardiac rehabilitation
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
6-minute walking distance
Key secondary outcomes
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
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Device,equipment | Other |
Interventions/Control_1
Asynchronous home-based cardiac rehabilitation with a smartwatch and a smartphone application
Interventions/Control_2
Usual asynchronous home-based cardiac rehabilitation
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10
Eligibility
Age-lower limit
| 20 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key 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
Key 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
Target sample size
150
Research contact person
Name of lead principal investigator
| 1st name | Toshiki |
| Middle name | |
| Last name | Kaihara |
Organization
St. Marianna University School of Medicine
Division name
Dapartment of Cardiology
Zip code
2168511
Address
2-16-1 Sugao, Miyamae-ku, Kawasaki, 216-8511, Japan
TEL
044-977-8111
tk-presen2@marianna-u.ac.jp
Public contact
Name of contact person
| 1st name | Toshiki |
| Middle name | |
| Last name | Kaihara |
Organization
St. Marianna University School of Medicine
Division name
Dapartment of Cardiology
Zip code
2168511
Address
2-16-1 Sugao, Miyamae-ku, Kawasaki, 216-8511, Japan
TEL
044-977-8111
Homepage URL
tk-presen2@marianna-u.ac.jp
Sponsor or person
Institute
St. Marianna University School of Medicine
Institute
Department
Personal name
Funding Source
Organization
Japan Science and Technology Agency
Organization
Division
Category of Funding Organization
Japanese Governmental office
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
St. Marianna University School of Medicine
Address
2-16-1, Sugao, Miyamae-ku, Kawasaki, Kanagawa
Tel
0449778111
k-sienbu.mail@marianna-u.ac.jp
Secondary IDs
Secondary IDs
NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
Other administrative information
Date of disclosure of the study information
| 2024 | Year | 09 | Month | 01 | Day |
Related information
URL releasing protocol
Publication of results
Unpublished
Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Enrolling by invitation
Date of protocol fixation
| 2024 | Year | 07 | Month | 11 | Day |
Date of IRB
| 2024 | Year | 09 | Month | 10 | Day |
Anticipated trial start date
| 2024 | Year | 11 | Month | 01 | Day |
Last follow-up date
| 2027 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Progress (inclusion) is a little behind schedule
Management information
Registered date
| 2024 | Year | 07 | Month | 17 | Day |
Last modified on
| 2025 | Year | 07 | Month | 18 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000062838
