UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000025548 |
|---|---|
| Receipt number | 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 | 2020/01/14 11:06:37 |
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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 | 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
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
nakat@tif.ac.jp
Sponsor or person
Institute
Waseda University
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000029408
| Research Plan | |
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| Registered date | File name |
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| Registered date | File name |
| Research case data | |
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