UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000037985 |
|---|---|
| Receipt number | R000043297 |
| Scientific Title | A study on the safety of physiotherapy and its effectiveness on thermoregulatory responses |
| Date of disclosure of the study information | 2019/09/11 |
| Last modified on | 2019/09/11 09:21:18 |
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Basic information
Public title
A study on the safety of physiotherapy and its effectiveness on thermoregulatory responses
Acronym
Efficacy test of physical therapy for thermoregulatory response
Scientific Title
A study on the safety of physiotherapy and its effectiveness on thermoregulatory responses
Scientific Title:Acronym
Efficacy test of physical therapy for thermoregulatory response
Region
| Japan |
Condition
Condition
Healthy adults
Classification by specialty
| Not applicable | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To confirm the safety of physiotherapy and its effectiveness on thermoregulatory responses
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Evaluation of the sweating rate after the single treatment and the repeated treatment for 2 weeks with the physical therapy
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
Placebo
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Other |
Interventions/Control_1
Apply the physical therapy for whole body for 10 minutes once a day for 2 weeks
Interventions/Control_2
Apply the placebo therapy for whole body for 10 minutes once a day for 2 weeks
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
| 20 | years-old | <= |
Age-upper limit
| 59 | years-old | >= |
Gender
Male
Key inclusion criteria
Healthy males
Key exclusion criteria
Subjects deemed inappropriate to participate in this study by the principle investigator
Target sample size
16
Research contact person
Name of lead principal investigator
| 1st name | Junichi |
| Middle name | |
| Last name | Sugenoya |
Organization
Aichi Medical University
Division name
Department of Physiology
Zip code
480-1103
Address
Yazako-Karimata 1-1, Nagakute, Aichi
TEL
0561-62-3311
jka3451@nifty.com
Public contact
Name of contact person
| 1st name | Yuko |
| Middle name | |
| Last name | Morimoto |
Organization
Kao Corporation
Division name
Personal Health Care Products Research
Zip code
131-8501
Address
2-1-3, Bunka, Sumida-ku Tokyo 131-8501, Japan
TEL
+81-3-5630-9971
Homepage URL
morimoto.yuko@kao.co.jp
Sponsor or person
Institute
Aichi Medical University
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
Aichi Medical University, School of Medicine, Ethic Committee
Address
Yazako-Karimata 1-1, Nagakute, Aichi
Tel
0561-62-3311
amu_ethics@aichi-med-u.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
愛知医科大学（愛知県）
Other administrative information
Date of disclosure of the study information
| 2019 | Year | 09 | Month | 11 | Day |
Related information
URL releasing protocol
None
Publication of results
Unpublished
Result
URL related to results and publications
None
Number of participants that the trial has enrolled
16
Results
The thermoregulatory response changed in the group receiving physical therapy.
Results date posted
| 2019 | Year | 09 | Month | 11 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
a
Participant flow
a
Adverse events
None
Outcome measures
a
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2009 | Year | 09 | Month | 10 | Day |
Date of IRB
| 2009 | Year | 09 | Month | 10 | Day |
Anticipated trial start date
| 2010 | Year | 02 | Month | 02 | Day |
Last follow-up date
| 2010 | Year | 03 | Month | 05 | Day |
Date of closure to data entry
| 2010 | Year | 03 | Month | 05 | Day |
Date trial data considered complete
| 2010 | Year | 07 | Month | 27 | Day |
Date analysis concluded
| 2010 | Year | 07 | Month | 27 | Day |
Other
Other related information
Management information
Registered date
| 2019 | Year | 09 | Month | 11 | Day |
Last modified on
| 2019 | Year | 09 | Month | 11 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000043297
