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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000032862
Receipt No. R000037469
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)
Date of disclosure of the study information 2018/06/04
Last modified on 2018/06/04

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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

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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