UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000062501 |
|---|---|
| Receipt number | R000071550 |
| Scientific Title | Effects of six-week home-based neuromuscular electrical stimulation training on foot and lower leg muscle strength, physical performance, and cardiovascular function in older adults |
| Date of disclosure of the study information | 2026/08/07 |
| Last modified on | 2026/08/07 11:42:27 |
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Basic information
Public title
Effects of six-week home-based neuromuscular electrical stimulation training on muscle strength, physical performance, and blood pressure
Acronym
Evaluation of the effects of home-based neuromuscular electrical stimulation training
Scientific Title
Effects of six-week home-based neuromuscular electrical stimulation training on foot and lower leg muscle strength, physical performance, and cardiovascular function in older adults
Scientific Title:Acronym
Evaluation of the effects of home-based neuromuscular electrical stimulation training
Region
| Japan |
Condition
Condition
Healthy older adults
Classification by specialty
| Not applicable | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
to examine the effects of home-based NMES training performed with shortened and lengthened muscle on foot and lower leg muscle function, physical performance, and cardiovascular function, and compare these effects with those induced by traditional voluntary exercises in older adults.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Toe flexion strength, Ankle plantar flexion strength
Key secondary outcomes
Muscle thickness, 10-m walking time, Timed up and go test, brachial-ankle pulse wave velocity, systolic blood pressure, diastolic blood pressure
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Placebo
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
4
Purpose of intervention
Educational,Counseling,Training
Type of intervention
| Device,equipment |
Interventions/Control_1
Voluntary exercises training group
Participants in the voluntary exercise training group will perform 100 repetitions of seated towel gathering with a 3-kg weight attached to the towel, followed by two sets of 10 unilateral heel raises on each leg. The training will be performed six times per week for six weeks.
Interventions/Control_2
Neuromuscular electrical stimulation in seated position (SeNMES group)
Participants will undergo 15 minutes of neuromuscular electrical stimulation (NMES) training targeting the foot and lower leg muscles using a commercially available NMES device (SIXPAD Foot Fit 3, MTG Ltd., Nagoya, Japan), six times per week for six weeks. To account for muscle length during NMES training, participants will perform the intervention in a seated position, with the target muscles in a shortened position.
Interventions/Control_3
Participants in the standing NMES training group will undergo 15 minutes of neuromuscular electrical stimulation (NMES) training targeting the foot and lower leg muscles using a commercially available NMES device (SIXPAD Foot Fit 3, MTG Ltd., Nagoya, Japan), six times per week for six weeks. To provide NMES with the target muscles in a lengthened muscle position, the intervention will be performed in a standing position (standing NMES with stimulated muscles lengthened; StNMES group).
Interventions/Control_4
Control group
Participants in the control group will not undergo any training intervention during the study period. They will be instructed to maintain their usual daily activities for six 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
| 85 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Community-dwelling older adults who were capable of fully understanding the pre-study explanation and providing informed consent
Key exclusion criteria
Medical contraindications to exercise, inability to perform the experimental tasks
Individuals identified as being at high cardiovascular risk based on their medical history
Target sample size
60
Research contact person
Name of lead principal investigator
| 1st name | Kohei |
| Middle name | |
| Last name | Watanabe |
Organization
Chukyo University
Division name
School of Health and Sport Sciences
Zip code
470-0393
Address
101 Tokodachi, Kaizu-cho, Toyota, Aichi
TEL
0565-46-6599
wkohei@lets.chukyo-u.ac.jp
Public contact
Name of contact person
| 1st name | Norihide |
| Middle name | |
| Last name | Ishido |
Organization
Chukyo University
Division name
Graduate School of Health and Sport Sciences
Zip code
470-0393
Address
101 Tokodachi, Kaizu-cho, Toyota, Aichi
TEL
0565-46-6958
Homepage URL
n-ishido@mecl.chukyo-u.ac.jp
Sponsor or person
Institute
Chukyo university
Institute
Department
Personal name
Funding Source
Organization
MTG Co., Ltd.
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
Research Ethics Review Committee, School of Health and Sports Sciences, Chukyo University
Address
101 Tokodachi, Toyota, Aichi, JAPAN 470-0393
Tel
0565-46-6150
kenkyurinri@ml.chukyo-u.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 | 08 | Month | 07 | 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
83
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
| 2025 | Year | 01 | Month | 30 | Day |
Date of IRB
| 2025 | Year | 03 | Month | 10 | Day |
Anticipated trial start date
| 2025 | Year | 03 | Month | 11 | Day |
Last follow-up date
| 2025 | Year | 09 | 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 | 08 | Month | 07 | Day |
Last modified on
| 2026 | Year | 08 | Month | 07 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000071550
