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Name:
UMIN ID:

Recruitment status No longer recruiting
Unique ID issued by UMIN UMIN000024797
Receipt No. R000028532
Scientific Title The effect of a cognitive and golf training program on cognitive function in community-dwelling older adults: A randomized control trial
Date of disclosure of the study information 2016/11/11
Last modified on 2016/11/11

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Basic information
Public title The effect of a cognitive and golf training program on cognitive function in community-dwelling older adults: A randomized control trial
Acronym The effect of a golf training program on cognitive function
Scientific Title The effect of a cognitive and golf training program on cognitive function in community-dwelling older adults: A randomized control trial
Scientific Title:Acronym The effect of a golf training program on cognitive function
Region
Japan

Condition
Condition 65 year old or older
Classification by specialty
Geriatrics Rehabilitation medicine Adult
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To examine the effects of a golf program on cognitive function in older adults
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Cognitive function: MMSE, Wechsler Memory Scale-Revised Logical Memory, word list memory, digit span, modified digit symbol substitution test, modified trail making test
Key secondary outcomes Physical function: grip strength, gait, anthropometry, body composition
Biochemical examination of blood: total testosterone, free testosterone, DHEA-S, estradiol, albumin, CRP, HbA1c, glucose level, T-Chol, TG, HDL-C, LDL-C
Life function: kihon checklist, IADL
Psychological function: QOL, depression (GDS), life satisfaction

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Individual
Blinding Open -but assessor(s) are blinded
Control No treatment
Stratification NO
Dynamic allocation NO
Institution consideration Institution is not considered as adjustment factor.
Blocking NO
Concealment No need to know

Intervention
No. of arms 2
Purpose of intervention Prevention
Type of intervention
Behavior,custom
Interventions/Control_1 Intervention group: to participate in golf practice and a round of golf (once a week) and daily home-based exercise for 6 months
Interventions/Control_2 Control group: to receive a lecture on health (2 times per year)
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 1) older adults living in the Kanto area of Japan who were aged 65 years or over in July of 2016
2) people who have never played golf before or who play golf less than 1 time per year
3) people who can go to a golf range or hospital designated for examinations
4) people who agreed to participate in the study
Key exclusion criteria 1) people who cannot walk the golf course without riding in a cart
2) people diagnosed with type 1 diabetes mellitus, neurodegenerative disease, or psychiatric disorder
3) people diagnosed with dementia or mild cognitive impairment (MCI)
4) people suspected by a doctor to have dementia
5) people deemed ineligible by their general practitioner for participating in the intervention program
6) people certified with long-term care insurance
Target sample size 136

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 Prefecture
TEL 0562-44-5651
Email shimada@ncgg.go.jp

Public contact
Name of contact person
1st name
Middle name
Last name Sangyoon Lee
Organization National Center for Geriatrics and Gerontology
Division name Department of Preventive Gerontology
Zip code
Address 7-430 Morioka-cho, Obu City, Aichi Prefecture
TEL 0562-45-5638
Homepage URL
Email sylee@ncgg.go.jp

Sponsor
Institute National Center for Geriatrics and Gerontology
Institute
Department

Funding Source
Organization National Center for Geriatrics and Gerontology
Organization
Division
Category of Funding Organization Japanese Governmental office
Nationality of Funding Organization Japan

Other related organizations
Co-sponsor
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 国立研究開発法人国立長寿医療研究センター(愛知県)

Other administrative information
Date of disclosure of the study information
2016 Year 11 Month 11 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 No longer recruiting
Date of protocol fixation
2015 Year 12 Month 15 Day
Date of IRB
Anticipated trial start date
2016 Year 06 Month 30 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 11 Month 11 Day
Last modified on
2016 Year 11 Month 11 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000028532

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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