UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000042829 |
|---|---|
| Receipt number | R000048371 |
| Scientific Title | Effects of Neuromuscular Electrical Stimulation and Nutritional Therapy on Muscle Strengthening and Skeletal Muscle Hypertrophy |
| Date of disclosure of the study information | 2021/12/30 |
| Last modified on | 2022/06/26 12:22:37 |
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Basic information
Public title
Effects of Neuromuscular Electrical Stimulation and Nutritional Therapy on Muscle Strengthening and Skeletal Muscle Hypertrophy
Acronym
Effects of Neuromuscular Electrical Stimulation and Nutritional Therapy on Muscle Strengthening and Skeletal Muscle Hypertrophy
Scientific Title
Effects of Neuromuscular Electrical Stimulation and Nutritional Therapy on Muscle Strengthening and Skeletal Muscle Hypertrophy
Scientific Title:Acronym
Effects of Neuromuscular Electrical Stimulation and Nutritional Therapy on Muscle Strengthening and Skeletal Muscle Hypertrophy
Region
| Japan |
Condition
Condition
healthy adults
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Effects of Neuromuscular Electrical Stimulation and Nutritional Therapy on Muscle Strengthening and Skeletal Muscle Hypertrophy
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
muscle strength
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Single blind -participants are blinded
Control
Placebo
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
4
Purpose of intervention
Treatment
Type of intervention
| Food | Device,equipment |
Interventions/Control_1
neuromuscular electrical stimulation
Interventions/Control_2
nutritional therapy
Interventions/Control_3
Neuromuscular electrical stimulation combined with nutritional therapy
Interventions/Control_4
control
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10
Eligibility
Age-lower limit
| 18 | years-old | < |
Age-upper limit
| 30 | years-old | >= |
Gender
Male
Key inclusion criteria
Students who belong to the Faculty of Health and Welfare, Hiroshima University, who understand the content of the research and agree to cooperate.
Key exclusion criteria
History of orthopedic diseases of the hand
History of gastrointestinal diseases
History of renal disease
Experience participating in intervention studies with neuromuscular electrical stimulation
Target sample size
20
Research contact person
Name of lead principal investigator
| 1st name | Tomohiro |
| Middle name | |
| Last name | Ikeda |
Organization
Okayama University Hospital
Division name
Comprehensive Rehabilitation Department
Zip code
7008558
Address
Shikada-cho 2-5-1, Kita-ku, Okayama City, Okayama
TEL
08623587752
lirfranjitte@yahoo.co.jp
Public contact
Name of contact person
| 1st name | Tomohiro |
| Middle name | |
| Last name | Ikeda |
Organization
Okayama University Hospital
Division name
Comprehensive Rehabilitation Department
Zip code
7008558
Address
Shikada-cho 2-5-1, Kita-ku, Okayama City, Okayama
TEL
0862357752
Homepage URL
lirfranjitte@yahoo.co.jp
Sponsor or person
Institute
Okayama University Hospital
Institute
Department
Personal name
Funding Source
Organization
Hiroshima Prefectural 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
Hiroshima Prefectural University
Address
Gakuencho1-1 , Mihara City, Hiroshima
Tel
0848-60-1120
lirfranjitte@yahoo.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
Other administrative information
Date of disclosure of the study information
| 2021 | Year | 12 | Month | 30 | 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
20
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
| 2020 | Year | 08 | Month | 01 | Day |
Date of IRB
| 2020 | Year | 06 | Month | 12 | Day |
Anticipated trial start date
| 2020 | Year | 12 | Month | 01 | Day |
Last follow-up date
| 2021 | Year | 01 | Month | 20 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2020 | Year | 12 | Month | 23 | Day |
Last modified on
| 2022 | Year | 06 | Month | 26 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000048371
