UMIN-CTR Clinical Trial

Basic information
Public title	The effect of "A momotaro exercize"on communitydwelling elderly people
Acronym	The effect of "A momotaro exercize"
Scientific Title	Effects of preventive care exercises on communitydwelling elderly people
Scientific Title:Acronym	Effects of preventive care exercises
Region	Japan

Condition
Condition	flail,sarcopenia
Classification by specialty	Rehabilitation medicine Adult
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	Investigating what kind of impact physical and mental functions are having by performing "Appare momotaro execise",one of Okayama City's efforts to prevent frailty.
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Measure changes in TUG at initial assessment and after 3 and 6 months
Key secondary outcomes	Grip strength measurement,One leg standing time,30 seconds chair rise test,Long sitting forward bend

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 aged 65 and over who are not certified as needing longterm care
Key exclusion criteria	Poor physical condition
Target sample size	50

Research contact person
Name of lead principal investigator	1st name Kazunori Middle name Last name Kojima
Organization	Okayama Healthcare Professional University
Division name	Faculty of Health Sciences
Zip code	700-0913
Address	3-2-18,Daiku,Kitaku,Okayama,Japan
TEL	086-233-8020
Email	kojima@opu.ac.jp

Public contact
Name of contact person	1st name Kazunori Middle name Last name Kojima
Organization	Okayama Healthcare Professional University
Division name	Faculty of Health Sciences
Zip code	700-0913
Address	3-2-18,Daiku,Kitaku,Okayama,Japan
TEL	086-233-8020
Homepage URL
Email	kojima@opu.ac.jp

Sponsor
Institute	Okayama Healthcare Professional University
Institute
Department

Funding Source
Organization	Okayama Healthcare Professional University
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	Okayama Healthcare Professional University
Address	3-2-18,Daiku,Kitaku,Okayama,Japan
Tel	086-233-8020
Email	kojima@opu.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	2022 Year 11 Month 16 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	2022 Year 10 Month 01 Day
Date of IRB	2022 Year 09 Month 28 Day
Anticipated trial start date	2022 Year 11 Month 07 Day
Last follow-up date	2024 Year 03 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information	Observation study

Management information
Registered date	2022 Year 11 Month 14 Day
Last modified on	2022 Year 11 Month 14 Day

Link to view the page
URL(English)	https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000056024