UMIN-CTR Clinical Trial

BACK TOP
UMIN-CTR English Home Glossary (Simple) FAQ Search clinical trials

Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000032721
Receipt No. R000037311
Scientific Title Effect of cardiac rehabilitation on the exercise function in patients after the Fontan operation
Date of disclosure of the study information 2018/05/25
Last modified on 2018/12/06

* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments


Basic information
Public title Effect of cardiac rehabilitation on the exercise function in patients after the Fontan operation
Acronym Cardiac rehabilitation in patients after the Fontan operation
Scientific Title Effect of cardiac rehabilitation on the exercise function in patients after the Fontan operation
Scientific Title:Acronym Cardiac rehabilitation in patients after the Fontan operation
Region
Japan

Condition
Condition Patients after the Fontan operation
Classification by specialty
Cardiovascular surgery
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To clarify the efficacy of exercise therapy(cardiac rehabilitation) in patients after the Fontan operation
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes The achievement rate to the plan of exercise therapy
Key secondary outcomes Exercise tolerance, Quality of life, Muscular strength

Base
Study type Interventional

Study design
Basic design Single arm
Randomization Non-randomized
Randomization unit
Blinding Open -no one is blinded
Control Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 1
Purpose of intervention Educational,Counseling,Training
Type of intervention
Maneuver
Interventions/Control_1 Carry out 5-20 minutes ergometer exercises, supervised by doctors and physiotherapists. Training intensity is set under the load at the anaerobic threshold determined by cardiopulmonary exercise testing. Total exercise duration is 1-3 times weekly for 10-12 wekks.
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
12 years-old <=
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria 1) A patient with a Fontan circulation who meets the criteria of exercise therapy (cardiac rehabilitation) by health insurance
2) Height above 140cm
3) A patient who is not prohibited from exercising by doctors
4) A patient who is willing to participate in a training program, and able to give informed consent to participation
Key exclusion criteria A patient who correspond to contraindication to exercise therapy
Target sample size 30

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Muneaki Matsubara
Organization Faculty of Medicine, University of Tsukuba
Division name Department of Cardiovascular Surgery
Zip code
Address 1-1-1 Tennodai, Tsukuba, Ibaraki
TEL 029-853-3210
Email matsubaram@md.tsukuba.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Muneaki Matsubara
Organization Faculty of Medicine, University of Tsukuba
Division name Department of Cardiovascular Surgery
Zip code
Address 1-1-1 Tennodai, Tsukuba, Ibaraki
TEL 029-853-3210
Homepage URL
Email matsubaram@md.tsukuba.ac.jp

Sponsor
Institute Department of Cardiovascular Surgery, Faculty of Medicine, University of Tsukuba
Institute
Department

Funding Source
Organization Department of Cardiovascular Surgery, Faculty of Medicine, University of Tsukuba
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
Address
Tel
Email

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
2018 Year 05 Month 25 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
2018 Year 03 Month 16 Day
Date of IRB
Anticipated trial start date
2018 Year 06 Month 01 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
2018 Year 05 Month 25 Day
Last modified on
2018 Year 12 Month 06 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000037311

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


Contact us.