UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000054385 |
|---|---|
| Receipt number | R000062118 |
| Scientific Title | Effects on frailty prevention when using home EMS equipment and health food intake for 12 weeks: single blinded study |
| Date of disclosure of the study information | 2024/05/14 |
| Last modified on | 2024/09/17 10:22:18 |
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Basic information
Public title
Effects on frailty prevention when using home EMS equipment and health food intake for 12 weeks
Acronym
Amw Frailty study
Scientific Title
Effects on frailty prevention when using home EMS equipment and health food intake for 12 weeks: single blinded study
Scientific Title:Acronym
Effects on frailty prevention when using home EMS equipment and health food intake for 12 weeks
Region
| Japan |
Condition
Condition
Healthy adult
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Evaluate changes in frailty status when a specific exercise program is continued for 12 weeks, using an EMS device and consuming one type of healthy food.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Physical fitness measurement, muscle strength measurement, JOA score
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -but assessor(s) are blinded
Control
No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Food | Device,equipment |
Interventions/Control_1
Use of equipment, consumption of test foods, and specific exercise for 12 weeks
Interventions/Control_2
Life as usual for a certain period of time
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
| 50 | years-old | <= |
Age-upper limit
| 70 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
1.Subjects who have discomfort or pain in the knee joint
2.Subjects who have difficulty in standing up smoothly or walking for long periods of time.
Key exclusion criteria
1. Subjects who have a daily exercise routine/training
2. Subjects with a history of food allergies
3. Subjects who need assistance from others and are unable to walk independently
4. Subjects who are taking medicines that affect the test (e.g., knee joint pain, flail prevention, etc.)
5. who are in the hospital or taking prescription drugs
6. Who are undergoing treatment (hormone replacement therapy, drug therapy, or other) at a medical institution for the treatment or prevention of disease, or whose condition is judged to require treatment at the time consent is obtained.
7. Subjects have participated in any other human studies (all human studies using cosmetics, foods, pharmaceuticals, quasi-drugs, medical devices, etc.) within the past 4 weeks, or Subjects are scheduled to participate in any other human studies during the period when this study is scheduled to be conducted.
8. Other subjects deemed inappropriate by the study investigator.
Target sample size
26
Research contact person
Name of lead principal investigator
| 1st name | Takeshi |
| Middle name | |
| Last name | Kaneko |
Organization
Japan Clinical Trial Association
Division name
N.A.
Zip code
1600022
Address
5F, 4-3-17 Shinjuku, Shinjukuku, Tokyo
TEL
0364574666
info@yakujihou.org
Public contact
Name of contact person
| 1st name | Takeshi |
| Middle name | |
| Last name | Kaneko |
Organization
Japan Clinical Trial Association
Division name
N.A.
Zip code
1600022
Address
5F, 4-3-17 Shinjuku, Shinjukuku, Tokyo
TEL
0364574666
Homepage URL
info@yakujihou.org
Sponsor or person
Institute
Japan Clinical Trial Association
Institute
Department
Personal name
Funding Source
Organization
Amway Japan G.K.
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
Institutional Review Board of Pharmaceutical Law Wisdoms
Address
5F, 4-3-17 Shinjuku, Shinjukuku, Tokyo
Tel
0364574911
master@yakujihou.net
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
| 2024 | Year | 05 | Month | 14 | 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
30
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
Completed
Date of protocol fixation
| 2024 | Year | 04 | Month | 05 | Day |
Date of IRB
| 2024 | Year | 04 | Month | 18 | Day |
Anticipated trial start date
| 2024 | Year | 05 | Month | 14 | Day |
Last follow-up date
| 2024 | Year | 08 | Month | 09 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2024 | Year | 05 | Month | 13 | Day |
Last modified on
| 2024 | Year | 09 | Month | 17 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000062118
