UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000062799 |
|---|---|
| Receipt number | R000071893 |
| Scientific Title | A Prospective, Non-Randomized Comparative Effectiveness-Implementation Study of Apple Watch-Enabled, Multidisciplinary Tele-Cardiac Rehabilitation in Mainland Tokyo and the Tokyo Islands |
| Date of disclosure of the study information | 2026/09/03 |
| Last modified on | 2026/09/03 11:49:25 |
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Basic information
Public title
Remote Cardiac Rehabilitation for ISLAND in Japan
Acronym
ISLAND-HEART Japan
Scientific Title
A Prospective, Non-Randomized Comparative Effectiveness-Implementation Study of Apple Watch-Enabled, Multidisciplinary Tele-Cardiac Rehabilitation in Mainland Tokyo and the Tokyo Islands
Scientific Title:Acronym
ISLAND-HEART
Region
| Japan |
Condition
Condition
Cardiovascular disease
Classification by specialty
| Cardiology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Death
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Dose comparison
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Behavior,custom |
Interventions/Control_1
Rehabilitaion
Interventions/Control_2
Rehabilitaion
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
| 18 | years-old | <= |
Age-upper limit
| 100 | years-old | > |
Gender
Male and Female
Key inclusion criteria
Reha
Key exclusion criteria
age
Target sample size
60
Research contact person
Name of lead principal investigator
| 1st name | Atsuko |
| Middle name | |
| Last name | Nakayama |
Organization
Sakakibara Heart Institute
Division name
Cardiology
Zip code
1830003
Address
Fuchu-City, Asahi-Chou, 3-16-1
TEL
09013139964
atsukonakanaka@gmail.com
Public contact
Name of contact person
| 1st name | Atsuko |
| Middle name | |
| Last name | Nakayama |
Organization
Sakakibara Heart Institute
Division name
Cardiology
Zip code
1830003
Address
Fuchu-City, Asahi-Chou, 3-16-1
TEL
0423143111
Homepage URL
atsukonakanaka@gmail.com
Sponsor or person
Institute
Sakakibara
Institute
Department
Personal name
Funding Source
Organization
Sakakibara
Organization
Division
Category of Funding Organization
Non profit foundation
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Ethics Committee of Sakakibara Heart Institute
Address
Fuchu-City, Asahi-Chou, 3-16-1
Tel
0423143111
atsukonakanaka@gmail.com
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
| 2026 | Year | 09 | Month | 03 | 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
Preinitiation
Date of protocol fixation
| 2026 | Year | 09 | Month | 03 | Day |
Date of IRB
Anticipated trial start date
| 2026 | Year | 10 | Month | 30 | Day |
Last follow-up date
| 2028 | Year | 09 | Month | 30 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2026 | Year | 09 | Month | 03 | Day |
Last modified on
| 2026 | Year | 09 | Month | 03 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000071893
