UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000036093 |
|---|---|
| Receipt number | R000041079 |
| Scientific Title | Influence of different temperature warm bathing on Arterial stiffness in elderly subjects |
| Date of disclosure of the study information | 2019/04/01 |
| Last modified on | 2019/03/05 17:42:49 |
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Basic information
Public title
Influence of different temperature warm bathing
on Arterial stiffness in elderly subjects
Acronym
Influence of different temperature warm bathing
on Arterial stiffness in elderly subjects
Scientific Title
Influence of different temperature warm bathing
on Arterial stiffness in elderly subjects
Scientific Title:Acronym
Influence of different temperature warm bathing
on Arterial stiffness in elderly subjects
Region
| Japan |
Condition
Condition
Arteriosclerosis
Classification by specialty
| Cardiology | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The present study aimed to determine the effects of increases in body temperature by bathing in warm water on arterial stiffness in elderly subjects.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Changes in carotid-femoral pulse wave velocity and femoral-ankle PWV at baseline and 30, and 60 minutes after bathing, 35, 38, 40 celsius.
Key secondary outcomes
Changes in heart rate, blood pressure, rectal temperature at baseline and 30, and 60 minutes after bathing, 35, 38, 40 celsius.
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
| Behavior,custom |
Interventions/Control_1
35, 38,and 40 celsius for 15 minutes baths on a different day
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
| 65 | years-old | <= |
Age-upper limit
| 73 | years-old | >= |
Gender
Male
Key inclusion criteria
Healthy elderly subjects without exercise habits
Key exclusion criteria
Hypertension and obesity
Target sample size
16
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Junko Nogami |
Organization
TEIKYO Heisei University
Division name
Faculty of Health Care and Medical Sports Department
Zip code
Address
4-1 Uruidominami, Ichihara-City
TEL
0436-74-5511
j.nogami@thu.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Junko Nogami |
Organization
TEIKYO Heisei University
Division name
Faculty of Health Care and Medical Sports Department
Zip code
Address
4-1 Uruidominami, Ichihara-City
TEL
0436-74-6349
Homepage URL
j.nogami@thu.ac.jp
Sponsor or person
Institute
Graduate School of Comprehensive Human Sciences, University of Tsukuba
Institute
Department
Personal name
Funding Source
Organization
Japan Science and Technology Agency
Organization
Division
Category of Funding Organization
Japanese Governmental office
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Address
Tel
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
筑波大学大学総合研究棟D
Other administrative information
Date of disclosure of the study information
| 2019 | Year | 04 | 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
| 2009 | Year | 07 | Month | 24 | Day |
Date of IRB
Anticipated trial start date
| 2009 | Year | 10 | Month | 05 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2019 | Year | 03 | Month | 05 | Day |
Last modified on
| 2019 | Year | 03 | Month | 05 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000041079
