UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000047629 |
|---|---|
| Receipt number | R000040942 |
| Scientific Title | Observational study of QOL and ADL in lung transplant patients |
| Date of disclosure of the study information | 2022/04/30 |
| Last modified on | 2022/04/30 00:47:09 |
* 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
Observational study of QOL and ADL in lung transplant patients
Acronym
Observational study of QOL and ADL in lung transplantation
Scientific Title
Observational study of QOL and ADL in lung transplant patients
Scientific Title:Acronym
Observational study of QOL and ADL in lung transplantation
Region
| Japan |
Condition
Condition
Patients of lung tansplanatation in Tohoku University
Classification by specialty
| Rehabilitation medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The purpose of this study is to conduct prospective and retrospective observational research on QOL and ADL of patients who received brain-dead lung transplantation or living lung transplant at Tohoku University Hospital.
Basic objectives2
Others
Basic objectives -Others
It is important to investigate QOL, ADL, physical activity, exercise tolerance, first to grasp the present condition of lung transplant patients.
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Medical Outcomes Survey Short Form 12,EuroQol5 Dimension5 Level, St.George's respiratory questionnaire , P-ADL , 6MD , Daily Steps ,FAI , HADS
Key secondary outcomes
Base
Study type
Observational
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
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
| 18 | years-old | <= |
Age-upper limit
| 100 | years-old | > |
Gender
Male and Female
Key inclusion criteria
all
Key exclusion criteria
under 18 years old
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | Satoru |
| Middle name | |
| Last name | Ebihara |
Organization
Science Disability Sciences Tohoku University Graduate School of Medicine
Division name
Department of Internal Medicine & Rehabilitation
Zip code
9808574
Address
1-1,Seiryo-cho,Aoba-ku,Sendai
TEL
022-717-7353
ryotakaha@gmail.com
Public contact
Name of contact person
| 1st name | Ryo |
| Middle name | |
| Last name | Takahashi |
Organization
Science Disability Sciences Tohoku University Graduate School of Medicine
Division name
Department of Internal Medicine & Rehabilitation
Zip code
980-8574
Address
1-1,Seiryo-cho,Aoba-ku,Sendai
TEL
022-717-7353
Homepage URL
ryotakaha@gmail.com
Sponsor or person
Institute
Science Disability Sciences Tohoku University Graduate School of Medicine
Institute
Department
Personal name
Funding Source
Organization
Science Disability Sciences Tohoku University Graduate School 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
Science Disability Sciences Tohoku University Graduate School of Medicine
Address
1-1,Seiryo-cho,Aoba-ku,Sendai
Tel
022-717-7353
ryotakaha@gmail.com
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
| 2022 | Year | 04 | Month | 30 | 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
100
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
| 2018 | Year | 10 | Month | 03 | Day |
Date of IRB
| 2018 | Year | 10 | Month | 03 | Day |
Anticipated trial start date
| 2018 | Year | 10 | Month | 03 | Day |
Last follow-up date
| 2022 | Year | 08 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
none
Management information
Registered date
| 2022 | Year | 04 | Month | 30 | Day |
Last modified on
| 2022 | Year | 04 | Month | 30 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000040942
