UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000047661 |
|---|---|
| Receipt number | R000054344 |
| Scientific Title | Effects of physical activity interventions on fall risks in older people with the coexistence of sarcopenia and locomotive syndrome |
| Date of disclosure of the study information | 2022/09/01 |
| Last modified on | 2022/05/06 12:33:25 |
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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
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
ksanada@fc.ritsumei.ac.jp
Sponsor or person
Institute
Ritsumeikan university
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000054344
