UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000049056 |
|---|---|
| Receipt number | R000055893 |
| Scientific Title | Exercise therapy using a smartphone application in the maintenance phase of cardiac disease: a randomized controlled trial |
| Date of disclosure of the study information | 2022/09/30 |
| Last modified on | 2024/04/03 19:08:13 |
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Basic information
Public title
Exercise therapy using a smartphone application in the maintenance phase of cardiac disease: a randomized controlled trial
Acronym
Exercise therapy using a smartphone application in the maintenance phase of cardiac disease: a randomized controlled trial
Scientific Title
Exercise therapy using a smartphone application in the maintenance phase of cardiac disease: a randomized controlled trial
Scientific Title:Acronym
Exercise therapy using a smartphone application in the maintenance phase of cardiac disease: a randomized controlled trial
Region
| Japan |
Condition
Condition
Cardiac disease (ischemic heart disease, heart failure, post open heart surgery, post transcatheter aortic valve implantation)
Classification by specialty
| Cardiology | Surgery in general | Rehabilitation medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To examine the effectiveness of an exercise support tool (smartphone application) that has a function to encourage and feedback the target exercise amount to the subject during the maintenance phase of cardiac disease.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Peak VO2, peak oxygen uptake, at the start and after 6 months
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
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 | Other |
Interventions/Control_1
Intervention
The amount of exercise load, heart rate, exercise time, and exercise schedule deemed appropriate at the end of outpatient cardiac rehabilitation are set on a smartphone application, and the doctor or physiotherapist in charge provides exercise instruction (exercise method, exercise for at least 30 minutes three times a week, and how to indicate exercise achievement level) using the application.
Interventions/Control_2
Control
At the end of the outpatient cardiac rehabilitation, the doctor or physiotherapist in charge of the patient will provide verbal guidance on exercise in the maintenance phase (exercise method, heart rate during exercise, and exercise for at least 30 minutes three times a week).
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) Patients aged 18 years or older at the time of enrollment.
(2) Patients with cardiac disease (ischemic heart disease, heart failure, post open heart surgery, post transcatheter aortic valve implantation) who have received appropriate inpatient or outpatient treatment such as medication, percutaneous coronary intervention, or coronary artery bypass graft surgery, and who have already completed outpatient cardiac rehabilitation in the recovery period, and who have not experienced any new symptoms such as chest pain or dyspnea within one month of recruitment.
(3) The subject himself/herself has been fully informed of the study and has given written consent.
(4) The subject is able to operate the smartphone and application used in this study.
Key exclusion criteria
(1) Has a physical or cognitive impairment that would interfere with the performance of the research.
(2) Scheduled for other cardiovascular surgery.
(3) Complicated with malignant tumor or medical disease requiring aggressive treatment.
(4) The subject is in poor general condition and the expected prognosis is limited to a few months.
(5) The patient is otherwise deemed inappropriate as a subject in the judgment of the physician.
(6) The subject is incapable of operating the smartphone application and other devices used in this study.
Target sample size
90
Research contact person
Name of lead principal investigator
| 1st name | Takeshi |
| Middle name | |
| Last name | Nakamura |
Organization
Yokohama City University Hospital
Division name
Department of Rehabilitation Medicine
Zip code
236-0004
Address
3-9 Fukuura, Kanazawa-ward, Yokohama City, Kanagawa Prefecture, 236-0004 Japan
TEL
045-787-2800
take_n@yokohama-cu.ac.jp
Public contact
Name of contact person
| 1st name | Masatsugu |
| Middle name | |
| Last name | Okamura |
Organization
Yokohama City University
Division name
Department of Rehabilitation Medicine, School of Medicine
Zip code
236-0004
Address
3-9 Fukuura, Kanazawa-ward, Yokohama City, Kanagawa Prefecture, 236-0004 Japan
TEL
045-787-2713
Homepage URL
okamura@yokohama-cu.ac.jp
Sponsor or person
Institute
Yokohama City University
Institute
Department
Personal name
Funding Source
Organization
Japan Society for the Promotion of Science
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
Yokohama City University Hospital
Address
3-9 Fukuura, Kanazawa-ward, Yokohama City, Kanagawa Prefecture, 236-0004 Japan
Tel
045-370-7627
onodera@yokohama-cu.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 | 09 | Month | 30 | 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 | 09 | Month | 20 | Day |
Date of IRB
| 2022 | Year | 09 | Month | 20 | Day |
Anticipated trial start date
| 2022 | Year | 11 | Month | 01 | Day |
Last follow-up date
| 2026 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
| 2026 | Year | 09 | Month | 30 | Day |
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2022 | Year | 09 | Month | 29 | Day |
Last modified on
| 2024 | Year | 04 | Month | 03 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000055893
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