UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000023713 |
|---|---|
| Receipt number | R000027313 |
| Scientific Title | Effect of intake timing of protein, combined with a program of resistance exercises on the muscle mass and physical function of community-dewlling elderly |
| Date of disclosure of the study information | 2016/08/29 |
| Last modified on | 2022/07/08 10:04:48 |
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Basic information
Public title
Effect of intake timing of protein, combined with a program of resistance exercises on the muscle mass and physical function of community-dewlling elderly
Acronym
Intervention study of the total protein intake and resistance exercise for sarcopenia prevention
Scientific Title
Effect of intake timing of protein, combined with a program of resistance exercises on the muscle mass and physical function of community-dewlling elderly
Scientific Title:Acronym
Intervention study of the total protein intake and resistance exercise for sarcopenia prevention
Region
| Japan |
Condition
Condition
Sarcopenia
Classification by specialty
| Rehabilitation medicine | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To investigate effects of light-to-moderate resistance training combined with increased protein intake timing on the muscle mass, strength, and physical function, remission of sarcopenia of community-dwelling elderly.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
remission of sarcopenia (%)
Baseline. At the end of the intervention, 12 weeks after the end of the intervention, and 24 weeks after the end of the intervention.
Key secondary outcomes
skeletal muscle mass index, grip strength, knee extension strength, physical QOL
Baseline. At the end of the intervention, 12 weeks after the end of the intervention, and 24 weeks after the end of the intervention.
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -but assessor(s) are blinded
Control
Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
3
Purpose of intervention
Prevention
Type of intervention
| Behavior,custom |
Interventions/Control_1
resistance band exercise peformed 2 times per week for 24 week
Interventions/Control_2
resistance band exercise and protein intake timing peformed 2 times per week for 24 week
Interventions/Control_3
protein intake timing peformed 2 times per week for 24 week
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
| 65 | years-old | <= |
Age-upper limit
| 100 | years-old | > |
Gender
Male and Female
Key inclusion criteria
>65 years old, Sarcopenia
Key exclusion criteria
There is an indication of the dietary restrictions from doctor.
Without sarcopenia, Diabetes and chronic kidney disease, Severe dementia, dysphagia, Articular disease
resistance training, intake protein supplement
Target sample size
81
Research contact person
Name of lead principal investigator
| 1st name | Hiroyasu |
| Middle name | |
| Last name | Mori |
Organization
Tokushima University
Division name
Diabetes Therapeutics and Research Center
Zip code
0886337587
Address
3-18-15, Kuramoto-cho, Tokushima
TEL
0886337587
hiroyam31@gmail.com
Public contact
Name of contact person
| 1st name | Hiroyasu |
| Middle name | |
| Last name | Mori |
Organization
Tokushima University
Division name
Diabetes Therapeutics and Research Center
Zip code
0886337587
Address
3-18-15, Kuramoto-cho, Tokushima
TEL
0886337587
Homepage URL
hiroyam31@gmail.com
Sponsor or person
Institute
Tokushima University
Institute
Department
Personal name
Funding Source
Organization
Tokushima University
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Tokushima University Hospital
Address
2-50-1, Kuramoto-cho, Tokushima
Tel
0886313111
first-ec@tokushima-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
| 2016 | Year | 08 | Month | 29 | 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
Main results already published
Date of protocol fixation
| 2014 | Year | 07 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2014 | Year | 08 | Month | 15 | Day |
Last follow-up date
| 2016 | Year | 05 | Month | 01 | Day |
Date of closure to data entry
| 2017 | Year | 04 | Month | 01 | Day |
Date trial data considered complete
| 2017 | Year | 06 | Month | 01 | Day |
Date analysis concluded
| 2017 | Year | 07 | Month | 01 | Day |
Other
Other related information
Management information
Registered date
| 2016 | Year | 08 | Month | 22 | Day |
Last modified on
| 2022 | Year | 07 | Month | 08 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000027313
| Research Plan | |
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| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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