UMIN-CTR Clinical Trial

Basic information
Public title	Exploratory investigation on the effects of exercise and nutritional supplement on body composition and physical function of frail elderly
Acronym	Exploratory investigation on the effects of exercise and nutritional supplement on body composition and physical function of frail elderly
Scientific Title	Exploratory investigation on the effects of exercise and nutritional supplement on body composition and physical function of frail elderly
Scientific Title:Acronym	Exploratory investigation on the effects of exercise and nutritional supplement on body composition and physical function of frail elderly
Region	Japan

Condition
Condition	older adults
Classification by specialty	Rehabilitation medicine Adult
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To clarify the effects of exercise and nutrition on the body composition and physical function of elderly people Elderly
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	muscle mass
Key secondary outcomes	walking speed,grip strength,locomotive syndrome test,nutrition index

Base
Study type	Interventional

Study design
Basic design	Single arm
Randomization	Non-randomized
Randomization unit
Blinding	Open -no one is blinded
Control	Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	1
Purpose of intervention	Treatment
Type of intervention	Behavior,custom
Interventions/Control_1	Two times a week exercise and nutrition for 3 months
Interventions/Control_2
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	1)subjects over 70 years old 2)Subject applies to one or more diagnostic criteria of frail. 3)Subjects able to exercise continuously for 3 months. 4)Subjects with normal swallowing function. 5)Subject agreed to participate in research.
Key exclusion criteria	1) Subjects with protein intake restriction (serious renal function, liver dysfunction, diabetes) 2)Subjects regularly use protein-rich supplements or nutritional supplement drinks 3)Subjects with dementia. 4)Subjects are determined to be inappropriate for participating in research by the physician
Target sample size	20

Research contact person
Name of lead principal investigator	1st name Taiki Middle name Last name Komatsu
Organization	Nihon University
Division name	College of Sports Science
Zip code	154-8513
Address	3-34-1 Shimouma, Setagaya-ku, TOKYO 154-8513 JAPAN.
TEL	03-6453-1766
Email	komatsu.taiki@nihon-u.ac.jp

Public contact
Name of contact person	1st name Taiki Middle name Last name Komatsu
Organization	Nihon University
Division name	College of Sports Science
Zip code	154-8513
Address	3-34-1 Shimouma, Setagaya-ku, TOKYO 154-8513 JAPAN.
TEL	03-6453-1766
Homepage URL
Email	komatsu.taiki@nihon-u.ac.jp

Sponsor
Institute	College of Sports Science, Nihon University
Institute
Department

Funding Source
Organization	Otsuka Pharmaceutical 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	Nihon UNIV
Address	3-34-1Shimouma, Setagaya-ku, TOKYO 154-8513 JAPAN.
Tel	03-6453-1766
Email	komatsu.taiki@nihon-u.ac.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	2018 Year 10 Month 10 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 08 Month 26 Day
Date of IRB
Anticipated trial start date	2018 Year 09 Month 21 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	2018 Year 10 Month 09 Day
Last modified on	2020 Year 04 Month 10 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000039204