UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000051365 |
|---|---|
| Receipt number | R000058550 |
| Scientific Title | A feasibility study on intensive cardiac rehabilitation for Japanese patients with coronary artery disease |
| Date of disclosure of the study information | 2023/07/01 |
| Last modified on | 2023/06/17 15:39:25 |
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Basic information
Public title
A feasibility study on intensive cardiac rehabilitation for Japanese patients
Acronym
A feasibility study on ICR for Japanese patients
Scientific Title
A feasibility study on intensive cardiac rehabilitation for Japanese patients with coronary artery disease
Scientific Title:Acronym
A feasibility study on ICR in Japan
Region
| Japan |
Condition
Condition
Coronary Artery Disease
Classification by specialty
| Cardiology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
We developed a Japanese-style Intensive Cardiac Rehabilitation (ICR) program that is compatible with cardiovascular disease patients in Japan, and conduct a pilot study to examine its adherence, safety, and feasibility.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Adherence (program participation rate, daily exercise time/amount of activity at home, stress management practice time at home)
HEI(Healthy Eating Index)-2015
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Cluster
Blinding
Open -no one is blinded
Control
No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Educational,Counseling,Training
Type of intervention
| Behavior,custom |
Interventions/Control_1
Early group: Patients in the early group (12 cases) attend the program after the week after randomization.
Attend an online Japanese-style Intensive Cardiac Rehabilitation (ICR) program.
ICR; 3 hours per session, once a week, 12 weeks, (i) exercise guidance 40 minutes, (ii) food guidance (Japan diet centered on vegetarian) 40 minutes, (iii) mindfulness 40 minutes, (iv) group support 40 minutes conduct.
Twenty-four patients will be randomized 1:1 into 12 early and 12 late groups. Patients in the early group attend the program after the week after randomization. Patients in the late group attend the program after 12-week waiting period.
Interventions/Control_2
Late group: Patients in the late group (12 cases) attend the program after 12-week waiting period.
Attend an online Japanese-style Intensive Cardiac Rehabilitation (ICR) program (same program as early group).
ICR; 3 hours per session, once a week, 12 weeks, (i) exercise guidance 40 minutes, (ii) food guidance (Japan diet centered on vegetarian) 40 minutes, (iii) mindfulness 40 minutes, (iv) group support 40 minutes conduct.
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
| 75 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Patients meet all of the following inclusion criteria.
1. Diagnosed with coronary artery disease and treated by medical or non-medical therapy. Subjective symptoms and condition are stable.
2. Details of eligibility criteria of atherosclerotic heart disease
a. History of ischemic heart disease due to coronary artery stenosis diagnosed by cardiac catheterization or coronary CT angiography.
b. History of percutaneous coronary angioplasty (PCI), coronary artery bypass graft (CABG), or myocardial infarction.
c. Diagnosed with chronic heart failure due to ischemic cardiomyopathy.
3. Understanding and motivated for patient education program and basic self-management skills.
Key exclusion criteria
Exclude if any of the following criteria.
1.Patients with unstable medical condition of other diseases who are undergoing hospitalization or equivalent treatment, or who are likely to undergo such treatment.
2.Patients with active cancer.
3.Patients with following coronary artery diseases.
a. Unstable angina.
b. Within 3 months after catheter treatment such as PCI, CABG, myocardial infarction or other invasive treatment.
c. Hemodynamics and arrhythmia control are not stable.
4.Patients who have comorbidities (Crohn's disease, etc.) that require a special therapeutic diet, or who are receiving continuous individual nutritional guidance other than cardiac rehabilitation.
5.Patients with chronic kidney disease of grade 4 or higher and on maintenance dialysis.
6.Patients who have difficulty understanding the purpose and content of the program due to dementia, mental illness, etc.
7.Patients who are outpatients due to psychiatric disease.
8.Patients who have difficulty in attending Japanese language programs in an online environment.
9.Patients who have not been able to quit smoking.
10.Patients with substance-related disorder (alcohol, drug dependence, etc.).
11.Patients who are pregnant or may become pregnant.
12.Pacemaker, ICD (implantable cardioverter defibrillator), CRT-P, CRT-D (implantable cardiac resynchronization therapy) and other devices are implanted.
13.Patients deemed inappropriate by the attending physician.
Target sample size
24
Research contact person
Name of lead principal investigator
| 1st name | Neiko |
| Middle name | |
| Last name | Ozasa |
Organization
Kyoto University Hospital
Division name
Cardiovascular medicine
Zip code
606-8507
Address
54 Shogoin Kawahara-cho, Sakyo-ku, Kyoto
TEL
075-751-4255
nei126@kuhp.kyoto-u.ac.jp
Public contact
Name of contact person
| 1st name | Kazuhisa |
| Middle name | |
| Last name | Kaneda |
Organization
Kyoto University Hospital
Division name
Cardiovascular medicine
Zip code
606-8507
Address
54 Shogoin Kawahara-cho, Sakyo-ku, Kyoto
TEL
075-751-4255
Homepage URL
kazuhisaknd@kuhp.kyoto-u.ac.jp
Sponsor or person
Institute
Kyoto University Hospital
Institute
Department
Personal name
Neiko Ozasa
Funding Source
Organization
The Japanese Association of Cardiac Rehabilitation
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Kyoto University Hospital
Address
54 Shogoin Kawahara-cho, Sakyo-ku, Kyoto
Tel
075-751-4899
trans@kuhp.kyoto-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
京都大学医学部附属病院 (京都府）
Other administrative information
Date of disclosure of the study information
| 2023 | Year | 07 | 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
| 2023 | Year | 06 | Month | 06 | Day |
Date of IRB
Anticipated trial start date
| 2023 | Year | 07 | Month | 01 | Day |
Last follow-up date
| 2024 | Year | 06 | 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
| 2023 | Year | 06 | Month | 16 | Day |
Last modified on
| 2023 | Year | 06 | Month | 17 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000058550
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