UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000052995 |
|---|---|
| Receipt number | R000060456 |
| Scientific Title | Electrical muscle stimulation intervention study with Japanese elderly with sarcopenia or dynapenia: randomized-controlled trial |
| Date of disclosure of the study information | 2024/01/08 |
| Last modified on | 2023/12/04 17:06:53 |
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Basic information
Public title
Electrical muscle stimulation intervention study with Japanese elderly with sarcopenia or dynapenia: randomized-controlled trial
Acronym
Electrical muscle stimulation intervention study with Japanese elderly with sarcopenia or dynapenia
Scientific Title
Electrical muscle stimulation intervention study with Japanese elderly with sarcopenia or dynapenia: randomized-controlled trial
Scientific Title:Acronym
Electrical muscle stimulation intervention study with Japanese elderly with sarcopenia or dynapenia
Region
| Japan |
Condition
Condition
sarcopenia or presarcopenia or dynapenia
Classification by specialty
| Geriatrics | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To test the efficacy of electrical muscle stimulation on physical frailty
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
After 8- and 16-week intervention
Physical performance (gait speed, five-time chair stand test, short physical performance battery)
Key secondary outcomes
After 8- and 16-week intervention
Muscle mass
Muscle quality (phase angle)
Muscle strength (hand grip)
Cognitive function
Depression score
Quality of life
Autonomic nervous function
Height
Knee osteoarthritis function
Blood pressure
Arterial sclerosis
Urinary incontinence
Blood factors
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Single blind -investigator(s) and assessor(s) are blinded
Control
No treatment
Stratification
YES
Dynamic allocation
YES
Institution consideration
Institution is considered as a block.
Blocking
YES
Concealment
Pseudo-randomization
Intervention
No. of arms
3
Purpose of intervention
Treatment
Type of intervention
| Device,equipment |
Interventions/Control_1
Electrical muscle stimulation (-) 16 weeks
Protein (-) 16 weeks
Interventions/Control_2
Electrical muscle stimulation (+) 16 weeks
Protein (-) 16 weeks
Interventions/Control_3
Electrical muscle stimulation (+) 16 weeks
Protein (+) 16 weeks
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
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Sarcopenia
- Physical performance (gait speed<1.0 m/s or five-time chair stand test>=12 s or short physical performance battery<=9)
- Skeletal muscle index (male<7.0 kg/m2, female<5.7 kg/m2)
or presarcopenia
- Physical performance (gait speed>=1.0 m/s or five-time chair stand test<12 s or short physical performance battery>9)
- Skeletal muscle index (male<7.0 kg/m2, female<5.7 kg/m2)
or dynapenia
- Physical performance (gait speed<1.0 m/s or five-time chair stand test>=12 s or short physical performance battery<=9)
- Skeletal muscle index (male>=7.0 kg/m2, female>=5.7 kg/m2)
Key exclusion criteria
- Those who have electronic substances such as pacemakers and heart-lung machines in their bodies
- Those who have heart disease
- Those who have metal plates on their stomachs or thighs
- Those who cannot take protein
Target sample size
66
Research contact person
Name of lead principal investigator
| 1st name | Shu |
| Middle name | |
| Last name | Nishikori |
Organization
POLA CHEMICAL INDUSTRIES, INC.
Division name
FRONTIER RESEARCH CENTER
Zip code
244-0812
Address
Kashio-cho 560, Totsuka-ku, Yokohama, Kanagawa
TEL
045-826-7134
s-nishikori@pola.co.jp
Public contact
Name of contact person
| 1st name | Shu |
| Middle name | |
| Last name | Nishikori |
Organization
POLA CHEMICAL INDUSTRIES, INC.
Division name
FRONTIER RESEARCH CENTER
Zip code
244-0812
Address
Kashio-cho 560, Totsuka-ku, Yokohama, Kanagawa
TEL
045-826-7134
Homepage URL
s-nishikori@pola.co.jp
Sponsor or person
Institute
POLA CHEMICAL INDUSTRIES, INC.
Institute
Department
Personal name
Shu Nishikori
Funding Source
Organization
POLA CHEMICAL INDUSTRIES, INC.
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
Osekkaiclub Inc.
Name of secondary funder(s)
IRB Contact (For public release)
Organization
POLA CHEMICAL INDUSTRIES, INC.
Address
Kashio-cho 560, Totsuka-ku, Yokohama, Kanagawa
Tel
045-826-7232
y-miyasaka@pola.co.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
社会福祉法人新栄会 滝野川病院（東京都）
Other administrative information
Date of disclosure of the study information
| 2024 | Year | 01 | Month | 08 | 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
| 2023 | Year | 10 | Month | 10 | Day |
Date of IRB
| 2023 | Year | 10 | Month | 10 | Day |
Anticipated trial start date
| 2024 | Year | 01 | Month | 09 | Day |
Last follow-up date
| 2024 | Year | 05 | Month | 08 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2023 | Year | 12 | Month | 04 | Day |
Last modified on
| 2023 | Year | 12 | Month | 04 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000060456
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
