UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Effects on Cognitive Function in the Elderly Following Foot Bath with Water Soluble Extracts from the Leaves of Abies sachalinensis(Todomatsu)
Title of the study (Brief title)	Effect of Foot Bath with Water Soluble Extracts from the Leaves of Abies sachalinensis(Todomatsu)
Region	Japan

Condition
Condition	Elderly people who understand fragrance.
Classification by specialty	Adult
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	We conducted a foot bath with elderly people branched leaves on Water Soluble Extracts from the Leaves of Abies sachalinensis(Todomatsu) and examined how they affect cognitive function.
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	MCL-S.2 was carried out before and after the foot bath. TMT-B, VAS was carried out after the foot bath. Deep body temperature, through foot bath as intervention.
Key secondary outcomes

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	Prevention
Type of intervention	Behavior,custom
Interventions/Control_1	Foot bath at 43 degrees C for 15 minutes. Three patterns "hot water, Foot Bath with Water Soluble Extracts from the Leaves of Abies sachalinensis(Todomatsu), Only Water Soluble Extracts from the Leaves of Abies sachalinensis(Todomatsu) fragrance". Three patterns were conducted on different days.
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	Not applicable
Gender	Male and Female
Key inclusion criteria	Elderly people
Key exclusion criteria	Not have serious underlying disease. Elderly people who do not know the fragrance. Elderly people whose cognitive function has declined.
Target sample size	10

Research contact person
Name of lead principal investigator	Hiroya SHIMASAKI
Organization	Suzuka University of Medical Science
Division name	Department of Physical Therapy
Address	1001-1 Kishioka-cho, Suzuka-city, Mie 510-0293, Japan
TEL	059-383-9666
Email	shima-h@suzuka-u.ac.jp

Public contact
Name of contact person	Hiroya SHIMASAKI
Organization	Suzuka University of Medical Science
Division name	Department of Physical Therapy
Address	1001-1 Kishioka-cho, Suzuka-city, Mie 510-0293, Japan
TEL	059-383-9666
Homepage URL
Email	shima-h@suzuka-u.ac.jp

Sponsor
Institute	Oyamada Memorial Spa Hospital
Institute
Department

Funding Source
Organization	Japan Aroma Laboratory
Organization
Division
Category of Funding Organization	Other
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

Other administrative information
Date of disclosure of the study information	2018 Year 06 Month 04 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2017 Year 11 Month 27 Day
Anticipated trial start date	2017 Year 11 Month 27 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	Published
URL releasing results
Results
Other related information

Management information
Registered date	2018 Year 06 Month 04 Day
Last modified on	2018 Year 06 Month 04 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000037469