UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000027926 |
|---|---|
| Receipt number | R000031989 |
| Scientific Title | Investigation on physical function and ADL change in rehabilitation intervention for renal transplant patients |
| Date of disclosure of the study information | 2017/06/30 |
| Last modified on | 2017/06/25 17:39:20 |
* 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
Investigation on physical function and ADL change in rehabilitation intervention for renal transplant patients
Acronym
Rehabilitation for renal transplant patients
Scientific Title
Investigation on physical function and ADL change in rehabilitation intervention for renal transplant patients
Scientific Title:Acronym
Rehabilitation for renal transplant patients
Region
| Japan |
Condition
Condition
Chronic renal failure(Patients scheduled for renal transplantation)
Classification by specialty
| Nephrology | Vascular surgery | Rehabilitation medicine |
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To ascertain the effectiveness of rehabilitation intervention for renal transplant patient
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Phase III
Assessment
Primary outcomes
leg strength
Key secondary outcomes
sex,age,current medical history,medical history,blood data (Cr, Hb, etc.), moisture content in hospital (in-out),grip strength, walking ability, exercise tolerance (6 minutes Walk test), ADL (FIMcircumference of the lower limbs
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Self control
Stratification
Dynamic allocation
Institution consideration
Institution is not considered as adjustment factor.
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Maneuver |
Interventions/Control_1
From hospitalization until discharge to hospital,Rehabilitation conducted 20 times to 40 minutes five times a week
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
| 20 | years-old | <= |
Age-upper limit
| 80 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Adults who can agree from himself / herself
Key exclusion criteria
A minor
Target sample size
36
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Masahiro Ida |
Organization
Toranomon Hospital
Division name
Rehabilitation department
Zip code
Address
1-3-1 Kajigaya, Takatsu-ku, Kawasaki-shi, Kanagawa
TEL
0448775111
reha-pt@toranomon.gr.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Tetsuya Mizuno |
Organization
Toranomon Hospital
Division name
Rehabilitation department
Zip code
Address
1-3-1 Kajigaya, Takatsu-ku, Kawasaki-shi, Kanagawa
TEL
0448775111
Homepage URL
reha-pt@toranomon.gr.jp
Sponsor or person
Institute
Toranomon Hospital Rehabilitation department
Institute
Department
Personal name
Funding Source
Organization
Toranomon Hospital
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
Address
Tel
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
虎の門病院分院
Other administrative information
Date of disclosure of the study information
| 2017 | Year | 06 | 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
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
Open public recruiting
Date of protocol fixation
| 2016 | Year | 10 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2016 | Year | 10 | Month | 01 | Day |
Last follow-up date
| 2019 | Year | 03 | Month | 30 | Day |
Date of closure to data entry
| 2019 | Year | 04 | Month | 01 | Day |
Date trial data considered complete
Date analysis concluded
| 2019 | Year | 12 | Month | 31 | Day |
Other
Other related information
Management information
Registered date
| 2017 | Year | 06 | Month | 25 | Day |
Last modified on
| 2017 | Year | 06 | Month | 25 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000031989
