UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000023229 |
|---|---|
| Receipt number | 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 16:26:02 |
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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
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
akirakid@naramed-u.ac.jp
Sponsor or person
Institute
Nara Medical University
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000024968
