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Name:
UMIN ID:

Recruitment status
Unique ID issued by UMIN UMIN000023229
Receipt No. R000024968
Scientific Title The influence that perioperarive rehabilitation given to the quality of life and activities of daily living
Date of disclosure of the study information 2016/07/19
Last modified on 2016/07/19

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Basic information
Public title The influence that perioperarive rehabilitation given to the quality of life and activities of daily living
Acronym The influence that perioperarive rehabilitation given to the quality of life and activities of daily living
Scientific Title The influence that perioperarive rehabilitation given to the quality of life and activities of daily living
Scientific Title:Acronym The influence that perioperarive rehabilitation given to the quality of life and activities of daily living
Region
Japan

Condition
Condition Disease undergoing surgery and rehabilitation
Classification by specialty
Anesthesiology Operative medicine Rehabilitation medicine
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 to investigate how perioperative rehabilitation have the influence to quality of life and activities of daily living index
Basic objectives2 Others
Basic objectives -Others no
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Barthel Index
Key secondary outcomes TMIG Index
WHODAS2.0
SF-8

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
Blocking
Concealment

Intervention
No. of arms 1
Purpose of intervention Diagnosis
Type of intervention
Device,equipment Maneuver
Interventions/Control_1 surgery
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
55 years-old <=
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria Patients undergoing surgery in anesthesiology management
Patients who can answer the questionnaire
Key exclusion criteria Patients who can't answer to TMIG Index,SF-8, BI, WHODAS2.
Patients who undergo re-operation in hospitalization.
Patients who can't well understand Japanese
Patients who can't undergo evaluation of muscle mass and strength.
Patients who can't undergo rehabilitation.
Target sample size 500

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Kawaguchi Masahiko
Organization Nara Medical University
Division name Anestesiology
Zip code
Address 840 Shijo-cho, Kashihara, Nara 634-8522, Japan
TEL 0744-22-3051
Email drjkawa@gmail.com

Public contact
Name of contact person
1st name
Middle name
Last name Kido akira
Organization Nara Medical University
Division name Orthopedics
Zip code
Address 840 Shijo-cho, Kashihara, Nara 634-8522, Japan
TEL 0744-22-3051
Homepage URL
Email akirakid@naramed-u.ac.jp

Sponsor
Institute Nara Medical University
Institute
Department

Funding Source
Organization Nara prefecture
Organization
Division
Category of Funding Organization Local Government
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
2016 Year 07 Month 19 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
Date of protocol fixation
2016 Year 03 Month 31 Day
Date of IRB
Anticipated trial start date
2016 Year 08 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 intervention study
Everyone who meet the selection criteria in patients who underwent surgery at our facility in April 2016-March 2018
we finish to gather the patients when 600 patients were entried.

Management information
Registered date
2016 Year 07 Month 19 Day
Last modified on
2016 Year 07 Month 19 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000024968

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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