UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000054652 |
|---|---|
| Receipt number | R000062452 |
| Scientific Title | Are changes in muscle morphology that immediately after exercise in the intrinsic foot muscles a useful indicator of the outcome of a long-term intervention? |
| Date of disclosure of the study information | 2024/06/20 |
| Last modified on | 2024/06/13 15:12:57 |
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Basic information
Public title
Are changes in muscle morphology that immediately after exercise in the intrinsic foot muscles a useful indicator of the outcome of a long-term intervention?
Acronym
Are changes in muscle morphology that immediately after exercise in the intrinsic foot muscles a useful indicator of the outcome of a long-term intervention?
Scientific Title
Are changes in muscle morphology that immediately after exercise in the intrinsic foot muscles a useful indicator of the outcome of a long-term intervention?
Scientific Title:Acronym
Are changes in muscle morphology that immediately after exercise in the intrinsic foot muscles a useful indicator of the outcome of a long-term intervention?
Region
| Japan |
Condition
Condition
Healthy persons
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To clarify whether immediate muscle morphological changes that occur after intrinsic foot muscle exercise are useful predictors of muscle hypertrophy after long-term intervention
Basic objectives2
Safety
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Changes in muscle morphology of the intrinsic foot muscles
Change in foot morphology
Key secondary outcomes
Change in toe grip strength
Change in balance ability
Change in jump height
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Educational,Counseling,Training
Type of intervention
| Behavior,custom |
Interventions/Control_1
Strength training of intrinsic foot muscles
Interventions/Control_2
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
Participants who do not have any orthopedic disease of the lower limbs at the time of obtaining consent
Key exclusion criteria
Participants who have orthopedic disease of the lower limbs at the time of obtaining consent
Participants who are conducting strength training of the lower limbs at least twice a week
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | Makoto |
| Middle name | |
| Last name | Komiya |
Organization
Niigata University of Health and Welfare
Division name
Department of Physical Therapy
Zip code
9503198
Address
1398 Shimami-cho, Kita-ku, Niigata City, Niigata
TEL
0252576110
makoto-komiya@nuhw.ac.jp
Public contact
Name of contact person
| 1st name | Makoto |
| Middle name | |
| Last name | Komiya |
Organization
Niigata University of Health and Welfare
Division name
Department of Physical Therapy
Zip code
9503198
Address
1398 Shimami-cho, Kita-ku, Niigata City, Niigata
TEL
0252576110
Homepage URL
makoto-komiya@nuhw.ac.jp
Sponsor or person
Institute
Other
Institute
Department
Personal name
Funding Source
Organization
Other
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
Ethics Committee, Niigata University of Health and Welfare
Address
1398 Shimami-cho, Kita-ku, Niigata-shi, Niigata
Tel
0252574455
rinri@nuhw.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 | 06 | Month | 20 | 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 | 13 | Day |
Date of IRB
Anticipated trial start date
| 2024 | Year | 06 | Month | 20 | Day |
Last follow-up date
| 2026 | Year | 03 | 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 | 06 | Month | 13 | Day |
Last modified on
| 2024 | Year | 06 | Month | 13 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000062452
