UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000040620 |
|---|---|
| Receipt number | R000046359 |
| Scientific Title | A study on the effects of hot and cold alternating stimulation on post-exercise muscle fatigue recovery and relaxation of resting muscle tone. |
| Date of disclosure of the study information | 2020/06/23 |
| Last modified on | 2021/12/07 17:45:05 |
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Basic information
Public title
A Study to Determine the Effects of Repeated Hot and Cold Baths on Muscle Relaxation.
Acronym
A study on the effect of alternating baths on muscle relaxation.
Scientific Title
A study on the effects of hot and cold alternating stimulation on post-exercise muscle fatigue recovery and relaxation of resting muscle tone.
Scientific Title:Acronym
Study on the effect of alternating bathing on muscle fatigue recovery.
Region
| Japan |
Condition
Condition
Muscle fatigue and muscle tone
Classification by specialty
| Orthopedics | Adult | Child |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
With the increasing awareness of sports and exercise in modern society, the alternating bath is widely recognized as a method of recovering muscle fatigue after exercise. On the other hand, alternating baths require two bathtubs and the temperature of the water changes each time you take a bath. There are also hygiene issues when using a large number of people, and difficulties in adapting to people with disabilities. Therefore, a means of providing hot and cold stimulation that can more easily recover from fatigue is being sought. In this study, we will investigate whether thermoelectric devices and electric warmer and other simple hot and cold stimuli can be used for fatigue recovery.
Basic objectives2
Others
Basic objectives -Others
feasibility study
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Muscle stiffness, fatigue, and stiffness data that can be obtained with the muscle hardness tester/lower limb extension elevation test. Motor function/lifestyle data/fatigue/stiffness questionnaire.
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Self control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Other |
Interventions/Control_1
warm and cold stimulation
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
| 16 | years-old | <= |
Age-upper limit
| 100 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Volunteers who gave informed consent and obtained consent before conducting the study. The target age is 15 years or older.
Key exclusion criteria
Volunteers who gave informed consent before conducting the study and were rejected. In addition, patients are excluded if they have a pacemaker that is not compatible with MRI, if they have metal in their body such as a pacemaker or a cerebral artery clip, or if they are claustrophobic or otherwise unable to undergo normal MRI.
Target sample size
60
Research contact person
Name of lead principal investigator
| 1st name | Takeo |
| Middle name | |
| Last name | Nagura |
Organization
Nagura Clinic
Division name
Clinic
Zip code
103-0022
Address
7F-4-3 2chome muromachi nihonbashi chu-o-ku Tokyo
TEL
03-3279-1818
nagura@keio.jp
Public contact
Name of contact person
| 1st name | Takeo |
| Middle name | |
| Last name | Nagura |
Organization
Nagura Clinic
Division name
Clinic
Zip code
103-0022
Address
7F-4-3 2chome muromachi nihonbashi chu-o-ku Tokyo
TEL
03-3279-1818
Homepage URL
nagura@keio.jp
Sponsor or person
Institute
Nagura Clinic
Institute
Department
Personal name
Funding Source
Organization
Sony
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
P-One Clinic
Address
View Tower Hachioji 4F, 8-1 Yokamachi Hachioji City, Tokyo, 192-0071
Tel
042-625-5216
k-ogoe@p1-clinic.or.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
| 2020 | Year | 06 | Month | 23 | 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
Open public recruiting
Date of protocol fixation
| 2020 | Year | 06 | Month | 22 | Day |
Date of IRB
| 2020 | Year | 06 | Month | 25 | Day |
Anticipated trial start date
| 2020 | Year | 06 | Month | 25 | Day |
Last follow-up date
| 2023 | 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
| 2020 | Year | 06 | Month | 01 | Day |
Last modified on
| 2021 | Year | 12 | Month | 07 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000046359
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
