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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000023273
Receipt No. R000026822
Scientific Title Effects of group exercise on cognitive function and amount of conversation randomized control trial in older people with social frailty
Date of disclosure of the study information 2016/07/22
Last modified on 2016/07/21

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Basic information
Public title Effects of group exercise on cognitive function and amount of conversation randomized control trial in older people with social frailty
Acronym Effects of group exercise on cognitive functions and amount of conversation: RCT in older people with social frailty
Scientific Title Effects of group exercise on cognitive function and amount of conversation randomized control trial in older people with social frailty
Scientific Title:Acronym Effects of group exercise on cognitive functions and amount of conversation: RCT in older people with social frailty
Region
Japan

Condition
Condition Social frailty
Classification by specialty
Geriatrics Adult
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To examine the effects of group exercise on amount of conversation and cognitive functions
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2 Pragmatic
Developmental phase

Assessment
Primary outcomes 1)Cognitive function
Word memory
2)Communication in daily living
Key secondary outcomes 1)Physical activity
2)Cognitive function
Executive function
Attention
Processing speed
3)Brain volume
4)Depressive symptoms
5)Physical function
Grip strength
Gait speed

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Individual
Blinding Open -but assessor(s) are blinded
Control Active
Stratification NO
Dynamic allocation NO
Institution consideration
Blocking NO
Concealment

Intervention
No. of arms 2
Purpose of intervention Prevention
Type of intervention
Behavior,custom
Interventions/Control_1 Intervention group: Perform group exercise for 90 min /a week for 44 times
Interventions/Control_2 Control group: self-conducted activity using self-monitoring note
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
75 years-old <=
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria 1) Satisfy the criteria of social frailty
2) Being able to exercise
3) 75 years or older
4) Being agreed with participation in the study
Key exclusion criteria 1) Have serious or unstable illness
2) Have disability
3) Have difficulty in exercise
Target sample size 104

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Hiroyuki Shimada
Organization National Center for Geriatrics and Gerontology
Division name Department of Preventive Gerontology
Zip code
Address 7-430, Morioka-cho, Obu city, Aichi, 474-8511, Japan
TEL 0562-44-5651
Email shimada@ncgg.go.jp

Public contact
Name of contact person
1st name
Middle name
Last name Kota Tsutsumimoto
Organization National Center for Geriatrics and Gerontology
Division name Department of Preventive Gerontology
Zip code
Address 7-430, Morioka-cho, Obu city, Aichi, 474-8511, Japan
TEL 0562-44-5651
Homepage URL
Email k-tsutsu@ncgg.go.jp

Sponsor
Institute Department of Preventive Gerontology, National Center for Geriatrics and Gerontology
Institute
Department

Funding Source
Organization Japan Society for the Promotion of Science
Organization
Division
Category of Funding Organization Other
Nationality of Funding Organization Japanese

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

IRB Contact (For public release)
Organization
Address
Tel
Email

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
2016 Year 07 Month 22 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 Open public recruiting
Date of protocol fixation
2016 Year 04 Month 01 Day
Date of IRB
Anticipated trial start date
2016 Year 07 Month 25 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2016 Year 07 Month 21 Day
Last modified on
2016 Year 07 Month 21 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000026822

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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