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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000034984
Receipt No. R000039897
Scientific Title A randomized controlled trial of multicomponent original community-based exercise program and nutrition support in older adults
Date of disclosure of the study information 2019/01/01
Last modified on 2018/11/30

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Basic information
Public title A randomized controlled trial of multicomponent original community-based exercise program and nutrition support in older adults
Acronym Original community-based exercise program and nutrition support study
Scientific Title A randomized controlled trial of multicomponent original community-based exercise program and nutrition support in older adults
Scientific Title:Acronym Original community-based exercise program and nutrition support study
Region
Japan

Condition
Condition Healthy elderly adults (60years old or more)
Classification by specialty
Neurology Geriatrics Adult
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To examine the effects of original community-based exercise program and nutritional support associated with the improvement of cognitive and physical functions among the elderly.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2 Pragmatic
Developmental phase Not applicable

Assessment
Primary outcomes General cognitive function test
Body composition , Muscle mass,
Gait speed, Grip strength
Trail making test, and Working memory
osteocalcin
IGF-1
Albumen
BDNF
Key secondary outcomes Activities of daily living: Kihon checklist, Instrumental Activities of Daily Living (IADL)
Psychological function: Quality of Life (QOL), Geriatric Depression Scale (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
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Maneuver
Interventions/Control_1 Intervention group: Perform original community-based exercise program for 10 sessions over 6 months. Intervention group should consume a peptide beverage (containing 4000 mg of soybean peptide) for 1 month over 6 months.
Interventions/Control_2 Control group: Original community-based exercise program for the elderly should be performed in 10 sessions over 3 months.Next, exercise is done using DVDs for 3 months.
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

Not applicable
Gender Male and Female
Key inclusion criteria 1) Elderly adults who have participated
in cohort studies, 2) Native speaker
3) No limitations on age, sex, and medications.
Key exclusion criteria 1)Doctors orders to stop exercise
2) Medically advised not to participate in exercise
3) Dementia
Target sample size 80

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Masakazu Imaoka
Organization Osaka Kawasaki Rehabilitation University
Division name Department of Rehabilitation
Zip code
Address 158 Mizuma, Kaizuka City, Osaka Prefecture
TEL 072-446-6700
Email imaokamasakazu@gmail.com

Public contact
Name of contact person
1st name
Middle name
Last name Masakazu Imaoka
Organization Osaka Kawasaki Rehabilitation University
Division name Department of Rehabilitation
Zip code
Address 158 Mizuma, Kaizuka City, Osaka Prefecture
TEL 072-446-6700
Homepage URL
Email imaokamasakazu@gmail.com

Sponsor
Institute Osaka Kawasaki Rehabilitation University
Institute
Department

Funding Source
Organization FUJI OIL CO.,LTD
Organization
Division
Category of Funding Organization Profit organization
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

Other administrative information
Date of disclosure of the study information
2019 Year 01 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
2018 Year 12 Month 20 Day
Date of IRB
Anticipated trial start date
2019 Year 01 Month 24 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
2018 Year 11 Month 24 Day
Last modified on
2018 Year 11 Month 30 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000039897

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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