UMIN-CTR Clinical Trial

BACK TOP
UMIN-CTR English Home Glossary (Simple) FAQ Search clinical trials

Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000034411
Receipt No. R000039204
Scientific Title Exploratory investigation on the effects of exercise and nutritional supplement on body composition and physical function of frail elderly
Date of disclosure of the study information 2018/10/10
Last modified on 2019/09/06

* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments


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
Middle name
Last name Taiki Komatsu
Organization Nihon University
Division name College of Sports Science
Zip code
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
Middle name
Last name Taiki Komatsu
Organization Nihon University
Division name College of Sports Science
Zip code
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
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
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
2019 Year 09 Month 06 Day


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

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


Contact us.