UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000054853 |
|---|---|
| Receipt number | R000062674 |
| Scientific Title | The long-term effects of intrinsic foot muscle strengthening training with neuromuscular electrical stimulation and blood flow restriction-Comparative verification with neuromuscular electrical stimulation alone- |
| Date of disclosure of the study information | 2024/08/01 |
| Last modified on | 2024/07/02 14:24:35 |
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Basic information
Public title
The long-term effects of intrinsic foot muscle strengthening training with neuromuscular electrical stimulation and blood flow restriction-Comparative verification with neuromuscular electrical stimulation alone-
Acronym
The long-term effects of intrinsic foot muscle strengthening training with neuromuscular electrical stimulation and blood flow restriction-Comparative verification with neuromuscular electrical stimulation alone-
Scientific Title
The long-term effects of intrinsic foot muscle strengthening training with neuromuscular electrical stimulation and blood flow restriction-Comparative verification with neuromuscular electrical stimulation alone-
Scientific Title:Acronym
The long-term effects of intrinsic foot muscle strengthening training with neuromuscular electrical stimulation and blood flow restriction-Comparative verification with neuromuscular electrical stimulation alone-
Region
| Japan |
Condition
Condition
Healthy persons
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To confirm the long-term effect of a training method that combines blood flow restriction and neuromuscular electrical stimulation as a muscle strengthening exercise for the intrinsic foot muscles.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Muscle cross-sectional area
Key secondary outcomes
Toe flexor strength
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -but assessor(s) are blinded
Control
Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Other |
Interventions/Control_1
Neuromuscular electrical stimulation with blood flow restriction
Interventions/Control_2
Neuromuscular electrical stimulation
Interventions/Control_3
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
| 18 | years-old | <= |
Age-upper limit
| 30 | years-old | > |
Gender
Male and Female
Key inclusion criteria
Healthy college student
Key exclusion criteria
Abnormal blood pressure
Anemia
Exercise restrictions by doctors
Cardiovascular disease
Varicose vein
Lymphedema
Diabetes
Cancer
Kidney disease
History of stroke or seizure
Infection
Skin fragility
Lower limb injury
Surgical history less than a year ago
pregnancy (women only)
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | Kazunori |
| Middle name | |
| Last name | Okamura |
Organization
Prefectural University of Hiroshima
Division name
Faculty of Health and Welfare
Zip code
7230053
Address
1-1 Gakuen-cho, Mihara-shi, Hiroshima
TEL
0848601225
k-okamura@pu-hiroshima.ac.jp
Public contact
Name of contact person
| 1st name | Kazunori |
| Middle name | |
| Last name | Okamura |
Organization
Prefectural University of Hiroshima
Division name
Faculty of Health and Welfare
Zip code
723-0053
Address
1-1 Gakuen-cho, Mihara-shi, Hiroshima
TEL
0848601225
Homepage URL
k-okamura@pu-hiroshima.ac.jp
Sponsor or person
Institute
Prefectural University of Hiroshima
Institute
Department
Personal name
Funding Source
Organization
Ministry of education
Organization
Division
Category of Funding Organization
Japanese Governmental office
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Prefectural University of Hiroshima
Address
1-1 Gakuen-cho, Mihara-shi, Hiroshima
Tel
0848601225
k-okamura@pu-hiroshima.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
| 2024 | Year | 08 | Month | 01 | 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 | 07 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2024 | Year | 08 | Month | 01 | Day |
Last follow-up date
| 2026 | Year | 07 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2024 | Year | 07 | Month | 02 | Day |
Last modified on
| 2024 | Year | 07 | Month | 02 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000062674
