UMIN-CTR Clinical Trial

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
Email	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
Email	kentaka@juntendo.ac.jp

Sponsor
Institute	Juntendo Faculty University of Medicine
Institute
Department

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
Email	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
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000042904