UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Influence of different temperature warm bathing on Arterial stiffness in elderly subjects
Title of the study (Brief title)	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	Junko Nogami
Organization	TEIKYO Heisei University
Division name	Faculty of Health Care and Medical Sports Department
Address	4-1 Uruidominami, Ichihara-City
TEL	0436-74-5511
Email	j.nogami@thu.ac.jp

Public contact
Name of contact person	Junko Nogami
Organization	TEIKYO Heisei University
Division name	Faculty of Health Care and Medical Sports Department
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)

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

Progress
Recruitment status	Completed
Date of protocol fixation	2009 Year 07 Month 24 Day
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

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
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