UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000061888 |
|---|---|
| Receipt number | R000062435 |
| Scientific Title | Effects of Neuromuscular Electrical Stimulation and Pollock Protein on Lower Limb Muscle Strength in Elderly Hospitalized Patients |
| Date of disclosure of the study information | 2026/06/12 |
| Last modified on | 2026/06/12 14:22:07 |
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Basic information
Public title
Effects of Neuromuscular Electrical Stimulation and Pollock Protein on Lower Limb Muscle Strength in Elderly Hospitalized Patients
Acronym
Effects of Neuromuscular Electrical Stimulation and Pollock Protein on Lower Limb Muscle Strength in Elderly Hospitalized Patients
Scientific Title
Effects of Neuromuscular Electrical Stimulation and Pollock Protein on Lower Limb Muscle Strength in Elderly Hospitalized Patients
Scientific Title:Acronym
Effects of Neuromuscular Electrical Stimulation and Pollock Protein on Lower Limb Muscle Strength in Elderly Hospitalized Patients
Region
| Japan |
Condition
Condition
Patients admitted to the Community Comprehensive Care Unit
Classification by specialty
| Rehabilitation medicine | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The purpose of this study is to examine the effects of Neuromuscular Electrical Stimulation (NMES) combined with Alaska Pollack Protein (APP) on lower limb muscle strength in elderly hospitalized patients. Elderly patients admitted to the Community Comprehensive Care Unit were divided into three groups: a group receiving regular rehabilitation including NMES (regular rehabilitation group, NMES group), a group receiving regular rehabilitation plus NMES and whey protein (whey group), and a group receiving regular rehabilitation plus NMES and APP (APP group) for 6 weeks. The changes in muscle strength before and after 6 weeks will be compared. In addition, body composition, walking ability, grip strength, balance ability, nutritional status, and oral and swallowing function will be evaluated as secondary outcomes.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Knee extensor muscle strength before and after 6 weeks
Key secondary outcomes
Grip strength, muscle thickness (thigh), body composition, physical function (10m walking speed, Short Physical Performance Battery), ADL (FIM), frailty (Kihon checklist), nutrition (Mini-Nutritional Assessment), and oral and swallowing function (tongue pressure, Oral Health Assessment) before and after 6 weeks
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Double blind -all involved are blinded
Control
Active
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
Conventional rehabilitation for 6 weeks
Interventions/Control_2
Neuromuscular electrical stimulation (30 min/day, 5 times/week) in addition to conventional rehabilitation for 6 weeks
Interventions/Control_3
Neuromuscular electrical stimulation (30 min/day, 5 times/week) and whey protein (4.5 g/day, 7 days/week) in addition to conventional rehabilitation for 6 weeks
Interventions/Control_4
Neuromuscular electrical stimulation (30 min/day, 5 times/week) and Alaska Pollack Protein (4.5 g/day, 7 days/week) in addition to conventional rehabilitation for 6 weeks
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
| 90 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
1) Participants who are eligible for oral intake of food (regardless of whether or not they are able to eat independently)
2) Participants who have been fully informed about their participation in this study, and who have given written consent of their own free will based on their full understanding of the study
Key exclusion criteria
The participants who fall into any of the following criteria will not be included in this study.
1) Participants with food allergies to dairy products, fish, eggs, wheat, soybeans, etc.
2) Participants with restricted protein intake
3) Participants who have an electronic device inserted in the body, such as a pacemaker, that can be affected by electrical stimulation of NMES
4) Participants with severe sensory impairment
5) Participants with progressive neuromuscular diseases
6) Participants with malignant tumors
7) Participants with a history of peripheral nerve disease of the lower limb
8) Participants with a history of cerebrovascular disease (Brunnstrome stage < V of the lower limb )
9) Participants who have been instructed by a physician to limit their activities, such as not-bearing or bed rest
10) Participants who are judged by the research director to be inappropriate to participate in the study for reasons other than those listed above
Target sample size
50
Research contact person
Name of lead principal investigator
| 1st name | Toshiaki |
| Middle name | |
| Last name | Miyamoto |
Organization
Kansai Medical University
Division name
Faculty of Rehabilitation
Zip code
573-1136
Address
Uyamahigashimachi 18-89, Hirakata, Osaka
TEL
072-856-2361
miyamott@makino.kmu.ac.jp
Public contact
Name of contact person
| 1st name | Toshiaki |
| Middle name | |
| Last name | Miyamoto |
Organization
Kansai Medical University
Division name
Faculty of Rehabilitation
Zip code
573-1136
Address
Uyamahigashimachi 18-89, Hirakata, Osaka
TEL
072-856-2361
Homepage URL
miyamott@makino.kmu.ac.jp
Sponsor or person
Institute
Kansai Medical University
Institute
Department
Personal name
Funding Source
Organization
Nissui Corporation
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
Ethics Review Center, Kansai Medical University
Address
Shinmach 2-5-1, Hirakata, Osaka
Tel
072-804-0101
rinriirb@hirakata.kmu.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
| 2026 | Year | 06 | Month | 12 | 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
| 2024 | Year | 06 | Month | 22 | Day |
Date of IRB
Anticipated trial start date
| 2024 | Year | 06 | Month | 26 | Day |
Last follow-up date
| 2027 | Year | 06 | Month | 30 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2026 | Year | 06 | Month | 12 | Day |
Last modified on
| 2026 | Year | 06 | Month | 12 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000062435
