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Name:
UMIN ID:

Recruitment status No longer recruiting
Unique ID issued by UMIN UMIN000025548
Receipt No. R000029408
Scientific Title Effect of exercise and protein supplementation on the physical function and muscle force in frail elderly people : an intervention study
Date of disclosure of the study information 2017/01/05
Last modified on 2017/01/11

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Basic information
Public title Effect of exercise and protein supplementation on the physical function and muscle force in frail elderly people : an intervention study
Acronym Effect of exercise and protein supplementation on the physical and muscle function in frail elderly people
Scientific Title Effect of exercise and protein supplementation on the physical function and muscle force in frail elderly people : an intervention study
Scientific Title:Acronym Effect of exercise and protein supplementation on the physical and muscle function in frail elderly people
Region
Japan

Condition
Condition healthy person (frail elderly people)
Classification by specialty
Orthopedics 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 frail elderly people.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes 1) Change from baseline of muscle thickness at 3, 6 months.
2) Change from baseline of five-repetition sit-to-stand test time 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
6) Change from baseline of visual analog scale score at 3, 6 months

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Cluster
Blinding Single blind -investigator(s) and assessor(s) are blinded
Control No treatment
Stratification YES
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 3
Purpose of intervention Treatment
Type of intervention
Food
Interventions/Control_1 (Exercise group) Taking a couple of tea after exercise twice a week at care prevention school of Himi city.
Interventions/Control_2 (Protein group) Taking protein supplement (20g at a time) after exercise twice a week at care prevention school of Himi city.
Interventions/Control_3 (EMR group) Taking protein supplement (20g at a time) including EMR (enzymatically modified rutin) (42mg) after exercise twice a week at care prevention school of Himi city.
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 school of Himi city
Key exclusion criteria 1) A person who cannot stand because of pain
2) A person who is restricted to take protein by the doctor
3) A person who cannot undergo a physical test
Target sample size 90

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

Public contact
Name of contact person
1st name
Middle name
Last name Takuto Nakamura
Organization Toyama Medical Welfare College
Division name Department of Physical Therapy
Zip code
Address 149-9 Yanagihara Nerikawa,Toyama
TEL 076-476-0001
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
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
2017 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 No longer recruiting
Date of protocol fixation
2016 Year 12 Month 10 Day
Date of IRB
Anticipated trial start date
2016 Year 12 Month 10 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
2017 Year 01 Month 05 Day
Last modified on
2017 Year 01 Month 11 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000029408

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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