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Name:
UMIN ID:

Recruitment status No longer recruiting
Unique ID issued by UMIN UMIN000038510
Receipt No. R000043877
Scientific Title Effect of exercise and protein supplementation on the physical function and muscle force in participants in care prevention program
Date of disclosure of the study information 2019/11/15
Last modified on 2020/05/14

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Basic information
Public title Effect of exercise and protein supplementation on the physical function and muscle force in participants in care prevention program
Acronym Effect of exercise and protein supplementation on the physical function and muscle force in participants in care prevention program
Scientific Title Effect of exercise and protein supplementation on the physical function and muscle force in participants in care prevention program
Scientific Title:Acronym Effect of exercise and protein supplementation on the physical function and muscle force in participants in care prevention program
Region
Japan

Condition
Condition healthy elderly person
Classification by specialty
Not applicable Adult
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To explore the effect of exercise and protein supplementation on the physical function and muscle force in participants in care prevention program.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Change from baseline of muscle thickness at 3, 6 months.
Key secondary outcomes 1) Change from baseline of five-repetition sit-to-stand test time at 3, 6 months.
2) Change from baseline of 5 m walking speed at 3, 6 months.
3) Change from baseline of Get-Up and Go test time at 3, 6 months
4) Change from baseline of one-legged blind balance time at 3, 6 months
5) Change from baseline of grip strength at 3, 6 months

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Cluster
Blinding Open -no one is blinded
Control No treatment
Stratification YES
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Food
Interventions/Control_1 (Exercise group) Drinking water after exercise twice a week at care prevention program of Himi city.
Interventions/Control_2 (Protein group) Taking protein supplement (15g at a time) after exercise twice a week at care prevention program of Himi city.
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
70 years-old <=
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria A person who attends care prevention program of Himi city
Key exclusion criteria 1)A person who cannot stand because of pain
2)Diabetic patient (HbA1c > 6.4%)
3)Kidney disease patient (eGFR < 50)
4)A person who is possible aspiration by screening evaluation
5)A person who cannot undergo a physical test
Target sample size 140

Research contact person
Name of lead principal investigator
1st name Koichiro
Middle name
Last name Oka
Organization Waseda University
Division name Faculty of Sport Sciences
Zip code 359-1192
Address 2-579-15 Mikajima Tokorozawa, Saitama
TEL 04-2947-6781
Email koka@waseda.jp

Public contact
Name of contact person
1st name Takuto
Middle name
Last name Nakamura
Organization Toyama Medical Welfare College
Division name Department of Physical Therapy
Zip code 936-0023
Address 149-9 Yanagihara Nerikawa,Toyama
TEL 076-476-001
Homepage URL
Email nakat@tif.ac.jp

Sponsor
Institute Waseda University
Institute
Department

Funding Source
Organization Morinaga & Co.,Ltd.
Organization
Division
Category of Funding Organization Profit organization
Nationality of Funding Organization

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

IRB Contact (For public release)
Organization Waseda University
Address 1-104 Totsukamachi, Shinjuku-ku, Tokyo
Tel 03-3202-2568
Email rps@list.waseda.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
2019 Year 11 Month 15 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
2019 Year 11 Month 01 Day
Date of IRB
2019 Year 10 Month 15 Day
Anticipated trial start date
2019 Year 11 Month 01 Day
Last follow-up date
2020 Year 05 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
2019 Year 11 Month 07 Day
Last modified on
2020 Year 05 Month 14 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000043877

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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