UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000059803 |
|---|---|
| Receipt number | R000068383 |
| Scientific Title | 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 |
| Date of disclosure of the study information | 2026/01/01 |
| Last modified on | 2025/11/18 00:58:14 |
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Basic information
Public title
Home Cardiac Rehabilitation Supported by Wearable Devices: Comparing Asynchronous and Real-Time Interactive Monitoring
Acronym
HEART-Link Trial (Hybrid Evaluation of Asynchronous and Real-time Telemonitoring for Cardiac Rehabilitation)
Scientific Title
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
Scientific Title:Acronym
HEART-Link Trial (Hybrid Evaluation of Asynchronous and Real-time Telemonitoring for Cardiac Rehabilitation)
Region
| Japan |
Condition
Condition
Patients aged 20 years or older attending outpatient cardiac rehabilitation
Classification by specialty
| Cardiology |
Classification by malignancy
Others
Genomic information
NO
Objectives
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
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Peak VO2
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
Active
Stratification
NO
Dynamic allocation
NO
Institution consideration
Institution is not considered as adjustment factor.
Blocking
NO
Concealment
Central registration
Intervention
No. of arms
3
Purpose of intervention
Treatment
Type of intervention
| Device,equipment | Behavior,custom |
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.
Interventions/Control_3
An educational intervention using a smart ring, in addition to a synchronous bidirectional educational intervention delivered through remote cardiac rehabilitation.
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 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 sample size
120
Research contact person
Name of lead principal investigator
| 1st name | Takahide |
| Middle name | |
| Last name | Kodama |
Organization
Toranomon Hospital
Division name
Department of Cardiology
Zip code
1058470
Address
2-2-2 Toranomon, Minato, Tokyo
TEL
03-3588-1111
kodak.circ@gmail.com
Public contact
Name of contact person
| 1st name | Takumi |
| Middle name | |
| Last name | Komatsu |
Organization
Toranomon Hospital
Division name
Department of Rehabilitation
Zip code
1058470
Address
2-2-2 Toranomon, Minato, Tokyo
TEL
03-3588-1111
Homepage URL
koma2.ta93@gmail.com
Sponsor or person
Institute
Toranomon Hospital
Institute
Department
Personal name
Takumi komatsu
Funding Source
Organization
Japan Heart Club
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
Toranomon Hospital
Address
2-2-2 Toranomon, Minato, Tokyo
Tel
03-3588-1111
chiken-jim@toranomon.gr.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
国家公務員共済組合連合会 虎の門病院
Other administrative information
Date of disclosure of the study information
| 2026 | Year | 01 | 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
Preinitiation
Date of protocol fixation
| 2026 | Year | 01 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2026 | Year | 01 | Month | 05 | Day |
Last follow-up date
| 2027 | Year | 10 | 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
| 2025 | Year | 11 | Month | 18 | Day |
Last modified on
| 2025 | Year | 11 | Month | 18 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000068383
