UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000030992 |
|---|---|
| Receipt number | R000035382 |
| Scientific Title | Intervention study on creation of diet and exercise therapy for sarcopenia treatment in community-dwelling elderly |
| Date of disclosure of the study information | 2018/09/01 |
| Last modified on | 2022/10/25 15:10:42 |
* 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
Intervention study on creation of diet and exercise therapy for sarcopenia treatment in community-dwelling elderly
Acronym
Diet and exercise intervention for sarcopenia treatment
Scientific Title
Intervention study on creation of diet and exercise therapy for sarcopenia treatment in community-dwelling elderly
Scientific Title:Acronym
Diet and exercise intervention for sarcopenia treatment
Region
| Japan |
Condition
Condition
sarcopenia
Classification by specialty
| Geriatrics | Rehabilitation medicine | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
We examine the effect of combined use of diet(mainly protein intake) and exercise therapy (mainlyresistance exercise) in elderly people who developed sarcopenia by intervention study.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Developmental phase
Phase II
Assessment
Primary outcomes
sarcopenia, low SMI, low grip strength, slow gait speed, muscle mass, grip strength, gait speed, knee extension strength, physical QOL
Key secondary outcomes
fall, QOL,fall risk, nutritional status,ADL, energy and protein intake
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
Active
Stratification
YES
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
3
Purpose of intervention
Treatment
Type of intervention
| Food | Behavior,custom |
Interventions/Control_1
Resistance exercise twice a week and eating habitual dietary energy and protein ingestion, and whey protein supplementation intake after resistance exercises
Interventions/Control_2
Resistance exercise twice a week and eating habitual dietary energy and protein ingestion
Interventions/Control_3
Eating habitual dietary energy and protein ingestion, and whey protein supplementation intake
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
| 85 | years-old | > |
Gender
Female
Key inclusion criteria
Applicant for Sarcopenia(diagnostic criteria of Asian Working Group for Sarcopenia. SMI, grip strength,gait speed < cutoff value)
Community center, or care center.
Key exclusion criteria
Diabetes, CKD, liver disease, resistance trainded elderly, joint and motor dysfunction, dementia, difficult to eat meals
Target sample size
75
Research contact person
Name of lead principal investigator
| 1st name | Hiroyasu |
| Middle name | |
| Last name | Mori |
Organization
Tokushima University
Division name
Institute of Advanced Medical Sciences
Zip code
7708503
Address
3-18-15, Kuramoto-cho, Tokushima, 770-8503
TEL
0886337587
hiroyam31@gmail.com
Public contact
Name of contact person
| 1st name | Hiroyasu |
| Middle name | |
| Last name | Mori |
Organization
Hyogo University
Division name
Institute of Advanced Medical Sciences
Zip code
7708503
Address
3-18-15, Kuramoto-cho, Tokushima, 770-8503
TEL
0886337587
Homepage URL
hiroyam31@gmail.com
Sponsor or person
Institute
Tokushima University
Institute
Department
Personal name
Funding Source
Organization
Ryo-syoku
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
University Hospital of Tokushima Clinical Trial Center for Developmental Therapeutics
Address
kuramoto-cho 3-18-15, tokushima city
Tel
088-633-7587
awachiken@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
| 2018 | Year | 09 | Month | 01 | 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
69
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
| 2018 | Year | 02 | Month | 01 | Day |
Date of IRB
| 2018 | Year | 02 | Month | 02 | Day |
Anticipated trial start date
| 2018 | Year | 08 | Month | 01 | Day |
Last follow-up date
| 2022 | Year | 08 | 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 | 01 | Month | 25 | Day |
Last modified on
| 2022 | Year | 10 | Month | 25 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000035382
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
|---|---|
| Registered date | File name |
| Research case data | |
|---|---|
| Registered date | File name |
