UMIN-CTR Clinical Trial

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
Email	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
Email	lirfranjitte@yahoo.co.jp

Sponsor
Institute	Okayama University Hospital
Institute
Department

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
Email	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
URL(English)	https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000048371