UMIN-CTR Clinical Trial
| Recruitment status | Completed |
| Unique ID issued by UMIN | UMIN000037985 |
| Receipt No. | 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 (Ver. 1) |
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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 | |
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| Condition | |||
| Condition | Healthy adults | ||
| Classification by specialty |
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| 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 |
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| 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 |
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| Age-upper limit |
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| 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 |
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| 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 |
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| 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 | |
| Institute | Aichi Medical University |
| Institute | |
| Department | |
| 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 |
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| 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. |
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| Results date posted |
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| Results Delayed | |||||||
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| Date of the first journal publication of results | |||||||
| Baseline Characteristics | a |
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| Participant flow | a |
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| Adverse events | None |
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| Outcome measures | a |
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| Plan to share IPD | |||||||
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| Progress | |||||||
| Recruitment status | Completed | ||||||
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| Date of closure to data entry |
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| Date trial data considered complete |
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| Date analysis concluded |
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| Other | |
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| Management information | |||||||
| Registered date |
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| Last modified on |
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| Link to view the page | |
| URL(English) | https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000043297 |
