UMIN-CTR Clinical Trial

Basic information
Public title	About the components of timed up and go test
Acronym	About the components of timed up and go test
Scientific Title	About the components of timed up and go test
Scientific Title:Acronym	About the components of timed up and go test
Region	Japan

Condition
Condition	aged people
Classification by specialty	Rehabilitation medicine
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	Identifying physical functions that affect the time spent on each component of the TUG
Basic objectives2	Others
Basic objectives -Others	Reduction of inspection time
Trial characteristics_1	Confirmatory
Trial characteristics_2	Pragmatic
Developmental phase	Not applicable

Assessment
Primary outcomes	Quadriceps muscle strength
Key secondary outcomes	Age / Gender / BMI / Grip strength / 10m walking test / Modified-Functional Reach Test / Mini Mental State Examination / Japanese version CHS

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	65 years-old <=
Age-upper limit	Not applicable
Gender	Male and Female
Key inclusion criteria	Elderly people who can walk alone living at home
Key exclusion criteria	MMSE 17 points or less
Target sample size	80

Research contact person
Name of lead principal investigator	1st name yukitaka/tooru Middle name Last name tomoda/nagao
Organization	Kosei hospital
Division name	Department of Rehabilitation
Zip code	651-1505
Address	Kusakbe Doujyou Kita Ward Kobe city Hoyogo prefecture
TEL	0789502622
Email	tomotomo19750423111@yahoo.co.jp

Public contact
Name of contact person	1st name Yukitaka Middle name Last name Tomoda
Organization	Kosei Hospital
Division name	Department of Rehabilitation
Zip code	651-1505
Address	Kusakbe Doujyou Kita Ward Kobe city Hoyogo prefecture
TEL	0789502622
Homepage URL
Email	tomotomo19750423111@yahoo.co.jp

Sponsor
Institute	Kosei Hospital
Institute
Department

Funding Source
Organization	not
Organization
Division
Category of Funding Organization	Self funding
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization	Kosei Hospital
Address	Kusakbe Doujyou Kita Ward Kobe city Hoyogo prefecture
Tel	0789502622
Email	tomotomo19750423111@yahoo.co.jp

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	2020 Year 12 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	81
Results	timed up and go test,grip,10m walking test,Modified Functional Reach test,Mini mental State Examination,Japanese Version CHS
Results date posted	2020 Year 12 Month 17 Day
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	Completed
Date of protocol fixation	2020 Year 10 Month 02 Day
Date of IRB	2020 Year 10 Month 10 Day
Anticipated trial start date	2020 Year 10 Month 13 Day
Last follow-up date	2021 Year 12 Month 31 Day
Date of closure to data entry	2021 Year 12 Month 31 Day
Date trial data considered complete	2021 Year 12 Month 31 Day
Date analysis concluded	2021 Year 12 Month 31 Day

Other
Other related information	none

Management information
Registered date	2020 Year 12 Month 17 Day
Last modified on	2022 Year 06 Month 23 Day

Link to view the page
URL(English)	https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000048018