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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000042911
Receipt No. R000047994
Scientific Title Effect of an accelerometer guided Intervention on lower limb muscle strength in older adults with sarcopenia
Date of disclosure of the study information 2021/01/05
Last modified on 2021/01/05

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Basic information
Public title Effect of an accelerometer guided Intervention on lower limb muscle strength in older adults with sarcopenia
Acronym Effect of an accelerometer guided Intervention on lower limb muscle strength in older adults with sarcopenia
Scientific Title Effect of an accelerometer guided Intervention on lower limb muscle strength in older adults with sarcopenia
Scientific Title:Acronym Effect of an accelerometer guided Intervention on lower limb muscle strength in older adults with sarcopenia
Region
Japan

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

Objectives
Narrative objectives1 To evaluate the effect of an accelerometer guided on lower limb muscle strength in older adults with sarcopenia.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Knee extension strength
(Using hand held dynamometer)
(24 weeks after the start of the intervention)
Key secondary outcomes Handgrip strength
5 time chair stand test
Skeletal muscle mass Index
Timed up & go test
Walking speed
Total energy expenditure
Step
Physical activity time
Dementia assessment sheet for community-based Integrated care system-8 items

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Individual
Blinding Open -no one is blinded
Control Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Behavior,custom
Interventions/Control_1 Accelerometer guided intervention
Ordinary rehabilitation
Guided self exercise
Guided physical activity
Interventions/Control_2 Ordinary rehabilitation
Guided self exercise
Guided physical activity
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 Possible sarcopenia
(Hand grip Male < 28kg,Female < 18kg)
(6m walk < 1.0m/s)
(5 time chair test > 12s)
Key exclusion criteria Mini-mental state examinaton < 21
gait walk < 0.4m/s
Target sample size 36

Research contact person
Name of lead principal investigator
1st name Kyohei
Middle name
Last name Kuramoto
Organization Nishinomiyakaisei hospital
Division name Rehabilitation department
Zip code 662-0957
Address 1-4 Ohamacho Nishinomiya-shi Hyogo-ken
TEL 0798-33-0601
Email kuramoto.kyohei@hmw.gr.jp

Public contact
Name of contact person
1st name Kyohei
Middle name
Last name Kuramoto
Organization Nishinomiyakaisei hospital
Division name Rehabilitation department
Zip code 662-0957
Address 1-4 Ohamacho Nishinomiya-shi Hyogo-ken
TEL 0798-33-0601
Homepage URL
Email kuramoto.kyohei@hmw.gr.jp

Sponsor
Institute Nishinomiyakaisei hostital
Institute
Department

Funding Source
Organization Hyogoiryou university graduate school
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 Nishinomiyakaisei hostital ethics committee
Address 1-4 Ohamacho Nishinomiya-shi Hyogo-ken
Tel 0798-33-0601
Email kuramoto.kyohei@hmw.gr.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 01 Month 05 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
2021 Year 01 Month 05 Day
Date of IRB
Anticipated trial start date
2021 Year 01 Month 12 Day
Last follow-up date
2022 Year 03 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
2021 Year 01 Month 05 Day
Last modified on
2021 Year 01 Month 05 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000047994

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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