UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000051634 |
|---|---|
| Receipt number | R000058921 |
| Scientific Title | Test of the mechanism of recovery from leg fatigue after standing and the effect of intervention. |
| Date of disclosure of the study information | 2023/09/01 |
| Last modified on | 2024/10/02 11:47:53 |
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Basic information
Public title
Recovery test of leg fatigue
Acronym
Recovery test of leg fatigue
Scientific Title
Test of the mechanism of recovery from leg fatigue after standing and the effect of intervention.
Scientific Title:Acronym
Recovery test of leg fatigue
Region
| Japan |
Condition
Condition
Not applicable
Classification by specialty
| Not applicable | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To examine the mechanisms of recovery from leg fatigue after standing and the effects of interventions.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Explanatory
Developmental phase
Not applicable
Assessment
Primary outcomes
Change in maximal voluntary muscle strength at the test site (right leg)
Key secondary outcomes
-Induced muscle strength, rate of force development, voluntary activation
-Tissue oxygen saturation, skin temperature, circumference, impedance, muscle stiffness, volume
-Subjective assessment (fatigue VAS, mood scale)
Base
Study type
Interventional
Study design
Basic design
Cross-over
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
10
Purpose of intervention
Treatment
Type of intervention
| Behavior,custom | Other |
Interventions/Control_1
(All 30 min.) Sitting - Supine position - Walking - Sitting - Gel sheet containinedg carbon dioxide and menthol (One sheet is attached to the calf of both legs)
Interventions/Control_2
(All 30 min.) Sitting - Supine position - Walking - Gel sheet containinedg carbon dioxide and menthol (One sheet is attached to the calf of both legs) - Sitting
Interventions/Control_3
(All 30 min.) Sitting - Walking - Supine position - Sitting - Gel sheet containinedg carbon dioxide and menthol (One sheet is attached to the calf of both legs)
Interventions/Control_4
(All 30 min.) Sitting - Walking - Supine position - Gel sheet containinedg carbon dioxide and menthol (One sheet is attached to the calf of both legs)
Interventions/Control_5
(All 30 min.) Supine position - Sitting - Walking - Sitting - Gel sheet containinedg carbon dioxide and menthol (One sheet is attached to the calf of both legs)
Interventions/Control_6
(All 30 min.) Supine position - Sitting - Walking - Gel sheet containinedg carbon dioxide and menthol (One sheet is attached to the calf of both legs) - Sitting
Interventions/Control_7
(All 30 min.) Supine position - Walking - Sitting - Sitting - Gel sheet containinedg carbon dioxide and menthol (One sheet is attached to the calf of both legs)
Interventions/Control_8
(All 30 min.) Supine position - Walking - Sitting - Gel sheet containinedg carbon dioxide and menthol (One sheet is attached to the calf of both legs) - Sitting
Interventions/Control_9
(All 30 min.) Walking - Sitting - Supine position - Sitting - Gel sheet containinedg carbon dioxide and menthol (One sheet is attached to the calf of both legs)
Interventions/Control_10
(All 30 min.) Walking - Sitting - Supine position - Sitting - Gel sheet containinedg carbon dioxide and menthol (One sheet is attached to the calf of both legs) - Sitting
Interventions 11: (All 30 min.) Walking - Supine position - Sitting - Sitting- Gel sheet containinedg carbon dioxide and menthol (One sheet is attached to the calf of both legs)
Interventions 12: (All 30 min.) Walking - Supine position - Sitting - Gel sheet containinedg carbon dioxide and menthol (One sheet is attached to the calf of both legs) - Sitting
Eligibility
Age-lower limit
| 18 | years-old | <= |
Age-upper limit
| 39 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
1. Men and women aged 18-39
Key exclusion criteria
1. Person who have experienced dizziness or anaemia due to standing for more than 10 minutes in the past.
2. Person who is unable to demonstrate muscle strength in a stable manner.
Target sample size
12
Research contact person
Name of lead principal investigator
| 1st name | Junko |
| Middle name | |
| Last name | Kitano |
Organization
Kao Corporation
Division name
Personal Health Care Products Research Lab.
Zip code
131-8501
Address
2-1-3, Bunka, Sumida-ku, Tokyo, 131-8501, JAPAN
TEL
+81-70-3300-8405
kitano.junko@kao.com
Public contact
Name of contact person
| 1st name | Shohei |
| Middle name | |
| Last name | Kimura |
Organization
Kao Corporation
Division name
Personal Health Care Products Research Lab.
Zip code
131-8501
Address
2-1-3, Bunka, Sumida-ku, Tokyo, 131-8501, JAPAN
TEL
+81-70-3300-8404
Homepage URL
kimura.shouhei@kao.com
Sponsor or person
Institute
Kao Corporation
Institute
Department
Personal name
Funding Source
Organization
Kao 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
Human Research Ethics Committee, Kao Corporation
Address
2-1-3, Bunka, Sumida-ku, Tokyo, 131-8501, JAPAN
Tel
+81-3-5630-9064
morisaki.naoko@kao.com
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
| 2023 | Year | 09 | 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
Completed
Date of protocol fixation
| 2023 | Year | 07 | Month | 13 | Day |
Date of IRB
| 2023 | Year | 07 | Month | 13 | Day |
Anticipated trial start date
| 2023 | Year | 09 | Month | 01 | Day |
Last follow-up date
| 2023 | Year | 12 | 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
| 2023 | Year | 07 | Month | 18 | Day |
Last modified on
| 2024 | Year | 10 | Month | 02 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000058921
