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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000027926
Receipt No. 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

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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
Email 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
Email reha-pt@toranomon.gr.jp

Sponsor
Institute Toranomon Hospital Rehabilitation department
Institute
Department

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
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 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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000031989

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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