UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000055018 |
|---|---|
| Receipt number | R000062843 |
| Scientific Title | Evaluation of the effectiveness of hot and cold stimulation for leg fatigue after standing |
| Date of disclosure of the study information | 2024/08/01 |
| Last modified on | 2025/01/20 11:31:54 |
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Basic information
Public title
Recovery test of leg fatigue
Acronym
Recovery test of leg fatigue
Scientific Title
Evaluation of the effectiveness of hot and cold stimulation for leg fatigue after standing
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 investigate the effectiveness of various hot and cold stimuli on leg fatigue after standing in adult men and women
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Developmental phase
Not applicable
Assessment
Primary outcomes
Maximum voluntary strength of plantar flexion
Key secondary outcomes
-Rate of torque development, surface electromyogram amplitude, evoked muscle force, voluntary activation
-Tissue oxygen saturation, skin temperature, circumference, volume, water content, muscle stiffness
-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
Placebo
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
10
Purpose of intervention
Treatment
Type of intervention
| Other |
Interventions/Control_1
(Apply one sheet to each leg for 30 minutes) Placebo - Carbon dioxide only - Menthol only - Carbon dioxide & menthol
Interventions/Control_2
(Apply one sheet to each leg for 30 minutes) Placebo - Menthol only - Carbon dioxide & menthol - Carbon dioxide only
Interventions/Control_3
(Apply one sheet to each leg for 30 minutes) Placebo - Carbon dioxide & menthol - Carbon dioxide only - Menthol only
Interventions/Control_4
(Apply one sheet to each leg for 30 minutes) Carbon dioxide only - Placebo - Menthol only - Carbon dioxide & menthol
Interventions/Control_5
(Apply one sheet to each leg for 30 minutes) Carbon dioxide only - Menthol only - Carbon dioxide & menthol - Placebo
Interventions/Control_6
(Apply one sheet to each leg for 30 minutes) Carbon dioxide only - Carbon dioxide & menthol - Placebo - Menthol only
Interventions/Control_7
(Apply one sheet to each leg for 30 minutes) Menthol only - Placebo - Carbon dioxide only - Carbon dioxide & menthol
Interventions/Control_8
(Apply one sheet to each leg for 30 minutes) Menthol only - Carbon dioxide only - Carbon dioxide & menthol - Placebo
Interventions/Control_9
(Apply one sheet to each leg for 30 minutes) Menthol only - Carbon dioxide & menthol - Placebo - Carbon dioxide only
Interventions/Control_10
(Apply one sheet to each leg for 30 minutes) Carbon dioxide & menthol - Placebo - Carbon dioxide only - Menthol only
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
2. Those who have felt any of the symptoms of "tiredness, swelling, or heaviness in their legs" in the past two weeks
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
Human 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
Human 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
Homepage URL
kimura.shouhei@kao.com
Sponsor or person
Institute
The University of Tokyo
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
| 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
13
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
| 2024 | Year | 07 | Month | 12 | Day |
Date of IRB
| 2024 | Year | 07 | Month | 12 | Day |
Anticipated trial start date
| 2024 | Year | 08 | Month | 01 | Day |
Last follow-up date
| 2024 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
No.of arms 12
Management information
Registered date
| 2024 | Year | 07 | Month | 19 | Day |
Last modified on
| 2025 | Year | 01 | Month | 20 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000062843
