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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000036093
Receipt No. 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

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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
Email 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
Email j.nogami@thu.ac.jp

Sponsor
Institute Graduate School of Comprehensive Human Sciences, University of Tsukuba
Institute
Department

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
Email

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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000041079

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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