UMIN-CTR Clinical Trial

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 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	076-476-0001
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	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	2017 Year 01 Month 05 Day

Related information
URL releasing protocol	Because we plan to submit a dissertation.
Publication of results	Unpublished

Result
URL related to results and publications	Because we plan to submit a dissertation.
Number of participants that the trial has enrolled	95
Results
Results date posted
Results Delayed	Delay expected
Results Delay Reason	Because we plan to submit a dissertation.
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	Completed
Date of protocol fixation	2016 Year 12 Month 10 Day
Date of IRB	2017 Year 01 Month 05 Day
Anticipated trial start date	2017 Year 01 Month 05 Day
Last follow-up date	2017 Year 11 Month 30 Day
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	2020 Year 01 Month 14 Day

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