UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000049220 |
|---|---|
| Receipt number | R000056059 |
| Scientific Title | The improvement of exercise tolerance according to understanding total amount of exercise by wearable pulse monitor in patients with cardiac rehabilitation |
| Date of disclosure of the study information | 2022/11/09 |
| Last modified on | 2022/10/14 17:18:17 |
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Basic information
Public title
The improvement of exercise tolerance according to understanding total amount of exercise by wearable pulse monitor in patients with cardiac rehabilitation
Acronym
The improvement of exercise tolerance by wearable pulse monitor in patients with cardiac rehabilitation
Scientific Title
The improvement of exercise tolerance according to understanding total amount of exercise by wearable pulse monitor in patients with cardiac rehabilitation
Scientific Title:Acronym
The improvement of exercise tolerance by wearable pulse monitor in patients with cardiac rehabilitation
Region
| Japan |
Condition
Condition
Cardiovascular disease
Classification by specialty
| Cardiology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The improvement of exercise tolerance according to understanding total amount of exercise by wearable pulse monitoring is evaluated.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
The improvement of oxygen consumption at anaerobic threshold by cardiopulmonary exercise test
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
Historical
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Educational,Counseling,Training
Type of intervention
| Device,equipment |
Interventions/Control_1
The patient attaches wearable pulse monitor, shares the data with staff, and receives exercise guidance for 5 months
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
An outpatient who started cardiac rehabilitation at Fukuoka University Hospital.
A patient who can attach wearable pulse monitor and share the data with staff for 5 months.
Key exclusion criteria
A patient who cannot exercise without Fukuoka University Hospital.
A patient who has allergy or sensitive skin to attach wearable pulse monitor.
A patient who implanted pacemaker device.
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | Shin-ichiro |
| Middle name | |
| Last name | Miura |
Organization
Fukuoka University School of Medicine
Division name
Department of Cardiology
Zip code
814-0180
Address
7-45-1 Nanakuma, Jonan-Ku, Fukuoka, Fukuoka
TEL
092-801-1011
miuras@cis.fukuoka-u.ac.jp
Public contact
Name of contact person
| 1st name | Yasunori |
| Middle name | |
| Last name | Suematsu |
Organization
Fukuoka University Hospital
Division name
Department of Cardiology
Zip code
814-0180
Address
7-45-1 Nanakuma, Jonan-Ku, Fukuoka, Fukuoka
TEL
092-801-1011
Homepage URL
ysuematsu@fukuoka-u.ac.jp
Sponsor or person
Institute
Fukuoka University
Institute
Department
Personal name
Funding Source
Organization
None
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
Fukuoka University Clinical Research & Ethics Centre
Address
7-45-1 Nanakuma, Jonan-Ku, Fukuoka, Fukuoka
Tel
092-801-1011
fumed-ethics@fukuoka-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
| 2022 | Year | 11 | Month | 09 | 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
| 2022 | Year | 10 | Month | 14 | Day |
Date of IRB
Anticipated trial start date
| 2022 | Year | 11 | Month | 09 | Day |
Last follow-up date
| 2025 | Year | 02 | Month | 28 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2022 | Year | 10 | Month | 14 | Day |
Last modified on
| 2022 | Year | 10 | Month | 14 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000056059
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
