UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000050248 |
|---|---|
| Receipt number | R000056292 |
| Scientific Title | Research for cardiac rehabilitation under remote supervision |
| Date of disclosure of the study information | 2023/02/06 |
| Last modified on | 2024/02/07 21:11:49 |
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Basic information
Public title
Research for cardiac rehabilitation under remote supervision
Acronym
Cardiac rehabilitation under remote supervision
Scientific Title
Research for cardiac rehabilitation under remote supervision
Scientific Title:Acronym
Cardiac rehabilitation under remote supervision
Region
| Japan |
Condition
Condition
Heart failure
Classification by specialty
| Cardiology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To clarify problems in cardiac rehabilitation under remote supervise and to examine the satisfaction of patients and health care professionals
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Assessment of problems by medical staff for cardiac rehabilitation under remote supervision
Satisfaction of healthcare professionals and patients for cardiac rehabilitation under remote supervision
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
| Behavior,custom |
Interventions/Control_1
Exercise training
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
| 18 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
(1)Clinical frailty scale 4-6
(2)Patients with cardiovascular disease (stable angina, medically stable post-myocardial infarction, chronic heart failure, post-operative cardiac or vascular surgery) who are in outpatient clinics or in hospital
Key exclusion criteria
(1)Unstable angina, uncontrolled hypertension (systolic blood pressure > 180/mmHg or diastolic blood pressure > 110/mmHg), severe aortic stenosis, uncontrolled arrhythmia, decompensated heart failure, acute aortic dissection
(2)Patients who judged to be not appropriate by the principal investigator.
Target sample size
10
Research contact person
Name of lead principal investigator
| 1st name | Kazuhiro |
| Middle name | |
| Last name | Yamamoto |
Organization
Tottori University
Division name
Department of Cardiovascular Medicine and Endocrinology and Metabolism, Faculty of Medicine
Zip code
683-8504
Address
36-1 Nishicho, Yonago
TEL
0859386517
ykazuhiro@tottori-u.ac.jp
Public contact
Name of contact person
| 1st name | Yoshiharu |
| Middle name | |
| Last name | Kinugasa |
Organization
Tottori University
Division name
Department of Cardiovascular Medicine and Endocrinology and Metabolism, Faculty of Medicine
Zip code
683-8504
Address
36-1 Nishicho, Yonago
TEL
0859386517
Homepage URL
ykinugasa-circ@tottori-u.ac.jp
Sponsor or person
Institute
Tottori University
Institute
Department
Personal name
Funding Source
Organization
Tottori University
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Research Cooperation Section, Management Planning Division, Yonago District Office.
Address
36-1 Nishicho, Yonago
Tel
0859-38-7108
me-kenkyu@ml.adm.tottori-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
| 2023 | Year | 02 | Month | 06 | 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
| 2022 | Year | 10 | Month | 25 | Day |
Date of IRB
| 2022 | Year | 10 | Month | 25 | Day |
Anticipated trial start date
| 2023 | Year | 01 | Month | 01 | Day |
Last follow-up date
| 2025 | 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
| 2023 | Year | 02 | Month | 06 | Day |
Last modified on
| 2024 | Year | 02 | Month | 07 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000056292
