UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000056452 |
|---|---|
| Receipt number | R000064510 |
| Scientific Title | K-PReP (Kawasaki-city Cardiac Prevention and Rehabilitation Consortium Project) registry clinical trial |
| Date of disclosure of the study information | 2024/12/16 |
| Last modified on | 2025/12/14 11:35:37 |
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Basic information
Public title
K-PReP (Kawasaki-city Cardiac Prevention and Rehabilitation Consortium Project) registry clinical trial
Acronym
K-PReP registry clinical trial
Scientific Title
K-PReP (Kawasaki-city Cardiac Prevention and Rehabilitation Consortium Project) registry clinical trial
Scientific Title:Acronym
K-PReP registry clinical trial
Region
| Japan |
Condition
Condition
Cardiac disease
Classification by specialty
| Cardiology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
We will verify the safety, feasibility, and effectiveness of using a smartphone app for outpatient asynchronous cardiac rehabilitation in the late recovery/maintenance phase, and build evidence. In addition, we will construct a dataset that can be utilized in various situations in the future.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Change in 6-minute walking distance
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Device,equipment |
Interventions/Control_1
Use of smartphone apps
Interventions/Control_2
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
Cardiac rehabilitation patients 20 years of age or older who have been discharged home after cardiac catheterization or surgery for cardiac disease and who retain a smartphone that enables them to perform daily activities of walking outdoors without a cane.
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 who cannot walk to the hospital with a cane or on their own
4) Patients with the following cardiac diseases (acute myocardial infarction [within 2 days of onset], pre-treatment unstable angina, uncontrolled arrhythmia, symptomatic severe aortic stenosis, uncontrolled symptomatic heart failure, acute pulmonary thromboembolism, acute myocarditis/pericarditis, acute aortic dissection, and after pacemaker/implantable cardioverter defibrillator implantation) (after pacemaker/implantable cardioverter-defibrillator implantation)
5) Pregnant and lactating patients
6) Patients with other serious diseases (e.g., cancer, collagen disease, etc.) for which the investigator determines that the patient is not suitable 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
Department of Cardiology
Zip code
2250003
Address
2-16-1 Sugao, Miyamae-ku, Kawasaki, 216-8511, Japan
TEL
0449778111
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
N/A
Organization
Division
Category of Funding Organization
Other
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 | 12 | Month | 16 | 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
| Delay expected |
Results Delay Reason
Patient enrollment is delayed.
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 | 12 | Month | 27 | Day |
Date of IRB
| 2024 | Year | 12 | Month | 11 | Day |
Anticipated trial start date
| 2024 | Year | 12 | Month | 16 | Day |
Last follow-up date
| 2026 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2024 | Year | 12 | Month | 13 | Day |
Last modified on
| 2025 | Year | 12 | Month | 14 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000064510
