UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000026366
Receipt number R000030269
Scientific Title Effect of aroma foot massage on cognitive function: Randomized controlled trial
Date of disclosure of the study information 2017/04/01
Last modified on 2017/03/02 15:22:30

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Basic information

Public title

Effect of aroma foot massage on cognitive function: Randomized controlled trial

Acronym

Aroma foot massage and cognitive function

Scientific Title

Effect of aroma foot massage on cognitive function: Randomized controlled trial

Scientific Title:Acronym

Aroma foot massage and cognitive function

Region

Japan


Condition

Condition

Mild Cognitive Impairment, Cognitive decline, Dimentia

Classification by specialty

Psychiatry Adult

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

To examine the effect of aroma foot massage on the cognitive function

Basic objectives2

Efficacy

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

Cognitive function
MoCA: The Montreal Cognitive Assessment
DSST: Digit Symbol Substitution Test

Key secondary outcomes



Base

Study type

Interventional


Study design

Basic design

Parallel

Randomization

Randomized

Randomization unit

Individual

Blinding

Open -but assessor(s) are blinded

Control

No treatment

Stratification


Dynamic allocation


Institution consideration


Blocking


Concealment



Intervention

No. of arms

2

Purpose of intervention

Prevention

Type of intervention

Maneuver

Interventions/Control_1

Three months 10 minutes daily of Aroma Foot Massage

Interventions/Control_2

live as usual

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

60 years-old <=

Age-upper limit

85 years-old >

Gender

Male and Female

Key inclusion criteria

1. Men and women who lives around Matsuyama city aged 60 years old or older.
2. Those who are able to join in the first and second examination
3. Those who are able to join in the 6 times of aroma foot massage class.
4. Those who are interested in the prevention of dementia or other disease, or promotion of health.
5. Those who joined in the explanation session and gave written informed consent.

Key exclusion criteria

1. Those who joined in the similar study we conducted in 2015 or 2016
2. Those who have severe cardiac disease.
3. Those who have severe hypertension (>180/110)
4. Those who have severe arhythmia.
5. Those who have other severe diseases.
6. Those who have allergy about the aroma oil (examined by patch test

Target sample size

120


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Eri Eguchi

Organization

Okayama University Graduate School of Medicine, Dentistry and Pharmaceutical Sciences

Division name

Public Health

Zip code


Address

2-5-1, Shikatacho, Kitaku, Okayama, Japan

TEL

+81-86-235-7184

Email

eri_eguchi@okayama-u.ac.jp


Public contact

Name of contact person

1st name
Middle name
Last name Eri Eguchi

Organization

Okayama University Graduate School of Medicine, Dentistry and Pharmaceutical Sciences

Division name

Public Health

Zip code


Address

2-5-1, Shikatacho, Kitaku, Okayama, Japan

TEL

+81-86-235-7184

Homepage URL


Email

eri_eguchi@okayama-u.ac.jp


Sponsor or person

Institute

Okayama University

Institute

Department

Personal name



Funding Source

Organization

AMED

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



Other administrative information

Date of disclosure of the study information

2017 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

Preinitiation

Date of protocol fixation

2017 Year 04 Month 18 Day

Date of IRB


Anticipated trial start date

2017 Year 04 Month 18 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

2017 Year 03 Month 02 Day

Last modified on

2017 Year 03 Month 02 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000030269


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name