UMIN-CTR Clinical Trial

Basic information
Public title	A study on the determining factors of gait speed based on type classification of standing posture in community-dwelling middle-aged and older people
Acronym	A study on the relationship of gait and standing posture
Scientific Title	A study on the determining factors of gait speed based on type classification of standing posture
Scientific Title:Acronym	A study on the determining factors of gait based on standing posture
Region	Japan

Condition
Condition	healthy middle-aged and older adults
Classification by specialty	Adult
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To investigate the determinant factors of gait ability based on type classification of standing posture in middle-aged and older adults.
Basic objectives2	Others
Basic objectives -Others	A cross-sectional study
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Gait parameter (gait speed, cadence, step length), Standing posture, Lower muscle strength, Lower angular velocity
Key secondary outcomes

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	50 years-old <=
Age-upper limit	Not applicable
Gender	Male and Female
Key inclusion criteria	Age 50 years and older
Key exclusion criteria	Patients with severe dementia Patients with moderate or severe respiratory disease Patients with moderate or severe cardiovascular disease
Target sample size	200

Research contact person
Name of lead principal investigator	1st name Akira Middle name Last name Iwata
Organization	Osaka Prefecture University
Division name	Graduate School of Comprehensive Rehabilitation
Zip code	583-8555
Address	3-7-30 Habikino, Habikino city, Osaka, Japan.
TEL	072-950-2111
Email	iwata@rehab.osakafu-u.ac.jp

Public contact
Name of contact person	1st name Atsuki Middle name Last name Kanayama
Organization	Osaka Prefecture University
Division name	Graduate School of Comprehensive Rehabilitation
Zip code	583-8555
Address	3-7-30 Habikino, Habikino city, Osaka, Japan.
TEL	072-950-2111
Homepage URL
Email	kanayama@rehab.osakafu-u.ac.jp

Sponsor
Institute	Osaka Prefecture University
Institute
Department

Funding Source
Organization	Grant-in-Aid for Scientific Research
Organization
Division
Category of Funding Organization	Japanese Governmental office
Nationality of Funding Organization

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

IRB Contact (For public release)
Organization	Committee on Research Ethics, The Graduate School of Comprehensive Rehabilitation, Osaka Prefecture University
Address	3-7-30 Habikino, Habikino city, Osaka, Japan.
Tel	072-950-2111
Email	yamamotos@rehab.osakafu-u.ac.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	2021 Year 09 Month 01 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	Enrolling by invitation
Date of protocol fixation	2021 Year 07 Month 01 Day
Date of IRB	2021 Year 09 Month 01 Day
Anticipated trial start date	2021 Year 09 Month 01 Day
Last follow-up date	2021 Year 10 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information	Observational study

Management information
Registered date	2021 Year 09 Month 01 Day
Last modified on	2021 Year 09 Month 01 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000051773