UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000037635 |
|---|---|
| Receipt number | R000042904 |
| Scientific Title | Respiratory rehabilitation and the evaluation of exercise intolerance for the patients after Fontan surgery |
| Date of disclosure of the study information | 2019/08/08 |
| Last modified on | 2019/08/08 15:22:04 |
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Basic information
Public title
Respiratory rehabilitation and the evaluation of exercise intolerance for the patients after Fontan surgery
Acronym
Respiratory rehabilitation and the evaluation of exercise intolerance for the patients after Fontan surgery
Scientific Title
Respiratory rehabilitation and the evaluation of exercise intolerance for the patients after Fontan surgery
Scientific Title:Acronym
Respiratory rehabilitation and the evaluation of exercise intolerance for the patients after Fontan surgery
Region
| Japan |
Condition
Condition
The patiens with complex congenital heart disease after Fontan procedure
Classification by specialty
| Cardiology | Pediatrics |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The aim of this study is to evaluate the effect of respiratory training for the patients after Fontan procedure with the cardiopulmonary exercise testing to measure exercise intolerance.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Exercise intolerance
Peak VO2/W (ml/kg/min)
Key secondary outcomes
Predicted %Peak VO2/W
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
NO
Dynamic allocation
NO
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Other |
Interventions/Control_1
Respiratory 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
| 13 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
The patients after Fontan surgery
Key exclusion criteria
The patients with mental retardation, arrhythmia or heart failure.
Target sample size
20
Research contact person
Name of lead principal investigator
| 1st name | Ken |
| Middle name | |
| Last name | Takahashi |
Organization
Juntendo Faculty University of Medicine
Division name
Department of Pediatrics
Zip code
113-8421
Address
2-1-1 Hongo Bunkyo-ku Tokyo Japan
TEL
03-3813-3111
kentaka@juntendo.ac.jp
Public contact
Name of contact person
| 1st name | Ken |
| Middle name | |
| Last name | Takahashi |
Organization
Juntendo Faculty University of Medicine
Division name
Department of Pediatrics
Zip code
113-8431
Address
2-1-1 Hongo Bunkyo-ku Tokyo Japan
TEL
03-3813-3111
Homepage URL
kentaka@juntendo.ac.jp
Sponsor or person
Institute
Juntendo Faculty University of Medicine
Institute
Department
Personal name
Funding Source
Organization
Juntendo Faculty University of Medicine
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
Juntendo Faculty University of Medicine
Address
2-1-1 Hongo Bunkyo-ku Tokyo Japan
Tel
03-3813-3111
kentaka@juntendo.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
| 2019 | Year | 08 | Month | 08 | 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
| 2017 | Year | 07 | Month | 28 | Day |
Date of IRB
| 2017 | Year | 07 | Month | 28 | Day |
Anticipated trial start date
| 2019 | Year | 08 | Month | 08 | 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
| 2019 | Year | 08 | Month | 08 | Day |
Last modified on
| 2019 | Year | 08 | Month | 08 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000042904
