UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000032862 |
|---|---|
| Receipt number | R000037469 |
| Scientific Title | 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 15:50:04 |
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Basic information
Public title
Effects on Cognitive Function in the Elderly Following Foot Bath with Water Soluble Extracts from the Leaves of Abies sachalinensis(Todomatsu)
Acronym
Effect of Foot Bath with Water Soluble Extracts from the Leaves of Abies sachalinensis(Todomatsu)
Scientific Title
Effects on Cognitive Function in the Elderly Following Foot Bath with Water Soluble Extracts from the Leaves of Abies sachalinensis(Todomatsu)
Scientific Title:Acronym
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
| 1st name | |
| Middle name | |
| Last name | Hiroya SHIMASAKI |
Organization
Suzuka University of Medical Science
Division name
Department of Physical Therapy
Zip code
Address
1001-1 Kishioka-cho, Suzuka-city, Mie 510-0293, Japan
TEL
059-383-9666
shima-h@suzuka-u.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Hiroya SHIMASAKI |
Organization
Suzuka University of Medical Science
Division name
Department of Physical Therapy
Zip code
Address
1001-1 Kishioka-cho, Suzuka-city, Mie 510-0293, Japan
TEL
059-383-9666
Homepage URL
shima-h@suzuka-u.ac.jp
Sponsor or person
Institute
Oyamada Memorial Spa Hospital
Institute
Department
Personal name
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)
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
Other administrative information
Date of disclosure of the study information
| 2018 | Year | 06 | Month | 04 | Day |
Related information
URL releasing protocol
Publication of results
Published
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
| 2017 | Year | 11 | Month | 27 | Day |
Date of IRB
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
Other
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000037469
