UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000021024 |
|---|---|
| Receipt number | R000024161 |
| Scientific Title | Will simple home Waon (thermal) therapy improve circulatory status and oxidative stress long term after Fontan operation? -First Waon (thermal) therapy trial in patients after Fontan operation |
| Date of disclosure of the study information | 2016/02/15 |
| Last modified on | 2023/08/22 16:19:47 |
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Basic information
Public title
Will simple home Waon (thermal) therapy improve circulatory status and oxidative stress long term after Fontan operation?
-First Waon (thermal) therapy trial in patients after Fontan operation
Acronym
Simple home Waon (thermal) therapy for the patients long term after Fontan operation
Scientific Title
Will simple home Waon (thermal) therapy improve circulatory status and oxidative stress long term after Fontan operation?
-First Waon (thermal) therapy trial in patients after Fontan operation
Scientific Title:Acronym
Simple home Waon (thermal) therapy for the patients long term after Fontan operation
Region
| Japan |
Condition
Condition
Patients long term after Fontan operation
Classification by specialty
| Pediatrics |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To assess the hypothesis that home Waon therapy may acutely and chronically improve the hemodynamics, oxidative stress, exercise tolerance in the patients long term after Fontan patients
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Noninvasively obtained hemodynamic and cardiovascular function, heart rate variability, exercise tolerance, daily work, oxidative stress, neurohormone at 6 months after Waon therapy
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
Self control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Device,equipment |
Interventions/Control_1
Waon therapy using far infrared dome sauna five times a week over one year
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
| 6 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
More than 1 year after Fontan operation
Age > 6 years
Patients who wish to participate the Waon therapy
Key exclusion criteria
severe heart failre
no consent to participate the study
patients who are not suitable for Waon theraphy, judged by attending physician
Target sample size
40
Research contact person
Name of lead principal investigator
| 1st name | Satoshi |
| Middle name | |
| Last name | Masutani |
Organization
Saitama Medical Center Saitama Medical University
Division name
Pediatric Cardiology
Zip code
350-8550
Address
1981 Kamoda, Kawagoe-shi, SAITAMA 350-8550, JAPAN
TEL
049-228-3550
smstn@ka2.so-net.ne.jp
Public contact
Name of contact person
| 1st name | Satoshi |
| Middle name | |
| Last name | Masutani |
Organization
Saitama Medical Center Saitama Medical University
Division name
Pediatric Cardiology
Zip code
350-8550
Address
1981 Kamoda, Kawagoe-shi, SAITAMA 350-8550, JAPAN
TEL
049-228-3400
Homepage URL
smstn@ka2.so-net.ne.jp
Sponsor or person
Institute
Saitama Medical Center Saitama Medical University
Institute
Department
Personal name
Funding Source
Organization
Miyata cardiac research promotion foundation
Organization
Division
Category of Funding Organization
Non profit foundation
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
IRB, Saitama Medical Ctr
Address
1981, Kamoda, Kawagoe, Saitama, zip 350-8550, Japan
Tel
049-228-3902
smcrinri@saitama-med.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
| 2016 | Year | 02 | Month | 15 | 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
No longer recruiting
Date of protocol fixation
| 2015 | Year | 09 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2016 | Year | 02 | Month | 15 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2016 | Year | 02 | Month | 15 | Day |
Last modified on
| 2023 | Year | 08 | Month | 22 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000024161
| 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 |
