UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000034411 |
|---|---|
| Receipt number | 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 | 2020/04/10 09:06:27 |
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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
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
komatsu.taiki@nihon-u.ac.jp
Sponsor or person
Institute
College of Sports Science, Nihon University
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000039204
