UMIN-CTR Clinical Trial

Basic information
Public title	Exercise habits and sarcopenia/locomotive syndrome
Acronym	Sarcopenia and locomotive syndrome
Scientific Title	Effects of physical activity interventions on fall risks in older people with the coexistence of sarcopenia and locomotive syndrome
Scientific Title:Acronym	Physical activity intervention for sarcopenia and locomotive syndrome
Region	Japan

Condition
Condition	sarcopenia
Classification by specialty	Geriatrics
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	This study was to investigate if the coexistence of sarcopenia and locomotive syndrome are associated with an increased risk of fall and worse ADL performance.
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Sarcopenia(muscle mass, muscle strength, performance), Locomotive syndrome(Locomo test), Frailty(J-CHS, Mini Mental State Examination, Geriatric Depression Scale 15, Kihon Checklist, Self-completed Occupational Performance Index)
Key secondary outcomes

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	Prevention
Type of intervention	Behavior,custom
Interventions/Control_1	Subjects will be subjected to a 12-week intervention experiment with the goal of "increasing walking time by 10 minutes per day". The first 2 weeks after the initial measurement will be a normal period, during which the subjects will lead a normal life without any specific instructions, followed by 10 weeks of walking intervention.
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	60 years-old <=
Age-upper limit	100 years-old >
Gender	Male and Female
Key inclusion criteria	1) less than 60 years old
Key exclusion criteria	2) participants with adrenal gland disease, heart disease, severe liver dysfunction, cirrhosis, severe renal dysfunction, and dementia. 3) participants who are pregnant or suspected of being pregnant, 4) participants who are outpatient for orthopedics or have limited exercise, and 5) participant who could not live without assistive and nursing care.
Target sample size	500

Research contact person
Name of lead principal investigator	1st name Kiyoshi Middle name Last name Sanada
Organization	Ritsumeikan university
Division name	Department of Sport and Health Science
Zip code	525-8577
Address	kusatsu
TEL	0775612674
Email	ksanada@fc.ritsumei.ac.jp

Public contact
Name of contact person	1st name KIYOSHI Middle name Last name SANADA
Organization	Ritsumeikan University
Division name	Department of Sport and Health Science
Zip code	525-8577
Address	1-1-1 Noji-Higashi, kusatsu, Shiga, 525-8577, Japan
TEL	0775612674
Homepage URL
Email	ksanada@fc.ritsumei.ac.jp

Sponsor
Institute	Ritsumeikan university
Institute
Department

Funding Source
Organization	Ritsumeikan university
Organization
Division
Category of Funding Organization	Other
Nationality of Funding Organization	Japan

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

IRB Contact (For public release)
Organization	Ritsumeikan University IRB
Address	1-1-1 Noji-Higashi, Kusatsu, Shiga, 525-8577, Japan
Tel	077-599-4175
Email	b-rinri@st.ritsumei.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 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	Preinitiation
Date of protocol fixation	2020 Year 04 Month 01 Day
Date of IRB
Anticipated trial start date	2022 Year 09 Month 01 Day
Last follow-up date	2027 Year 08 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date	2022 Year 05 Month 06 Day
Last modified on	2022 Year 05 Month 06 Day

Link to view the page
URL(English)	https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000054344