UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000032721 |
|---|---|
| Receipt number | 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 | 2024/10/25 18:48:26 |
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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 | MUNEAKI |
| Middle name | |
| Last name | MATSUBARA |
Organization
Faculty of Medicine, University of Tsukuba
Division name
Department of Cardiovascular Surgery
Zip code
3058575
Address
1-1-1 Tennodai, Tsukuba, Ibaraki
TEL
029-853-3210
matsubaram@md.tsukuba.ac.jp
Public contact
Name of contact person
| 1st name | MUNEAKI |
| Middle name | |
| Last name | MATSUBARA |
Organization
Faculty of Medicine, University of Tsukuba
Division name
Department of Cardiovascular Surgery
Zip code
3058575
Address
1-1-1 Tennodai, Tsukuba, Ibaraki
TEL
029-853-3210
Homepage URL
matsubaram@md.tsukuba.ac.jp
Sponsor or person
Institute
Department of Cardiovascular Surgery, Faculty of Medicine, University of Tsukuba
Institute
Department
Personal name
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
Tsukuba Clinical Research Development Organization
Address
2-1-1,Amakubo,Tsukuba,Ibaraki
Tel
029-853-3914
t-credo.adm@un.tsukuba.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
| 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
Completed
Date of protocol fixation
| 2018 | Year | 03 | Month | 16 | Day |
Date of IRB
| 2018 | Year | 03 | Month | 16 | Day |
Anticipated trial start date
| 2018 | Year | 06 | Month | 01 | Day |
Last follow-up date
| 2024 | 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
| 2018 | Year | 05 | Month | 25 | Day |
Last modified on
| 2024 | Year | 10 | Month | 25 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000037311
