UMIN-CTR Clinical Trial

Basic information
Public title	A study of the effects of FCD (Freedom Collaboration Dance) on brain fatigue
Acronym	A study of the effects of FCD (Freedom Collaboration Dance) on brain fatigue
Scientific Title	A study of the effects of FCD (Freedom Collaboration Dance) on brain fatigue
Scientific Title:Acronym	A study of the effects of FCD (Freedom Collaboration Dance) on brain fatigue
Region	Japan

Condition
Condition	Healthy
Classification by specialty	Adult
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	Examine psychological indicators before and after conducting the new exhalation type exercise program (Freedom Collaboration Dance: FCD)
Basic objectives2	Others
Basic objectives -Others	Change in blood plasmalogens before and after FCD
Trial characteristics_1
Trial characteristics_2
Developmental phase	Not applicable

Assessment
Primary outcomes	Examine the POMS2 (Profile of Mood States 2nd Edition) score after 4 weeks of FCD
Key secondary outcomes	Examine the results for the following items after 4 weeks of FCD 1. Change in psychological indicators (brain fatigue, sleep) 2. Change in plasmalogen and catecholamine blood levels 3. Change in salivary amylase 4. Change in BMI, body fat percentage

Base
Study type	Interventional

Study design
Basic design	Single arm
Randomization	Non-randomized
Randomization unit
Blinding	Open -no one is blinded
Control	Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	1
Purpose of intervention	Educational,Counseling,Training
Type of intervention	Behavior,custom
Interventions/Control_1	60 minute FCD studio lessons twice a week and training four times a week while watching a digitally delivered 15 minute video to be conducted at a place chosen at the subject's own discretion such as at home
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	20 years-old <=
Age-upper limit	50 years-old >
Gender	Female
Key inclusion criteria	Subjects who participate in sports less than 180 minutes a week
Key exclusion criteria	1. Subjects who have ingested plasmalogens within 3 months prior to commencement of the study or who may ingeste plasmalogens at some point by the end of the study 2. Subjects who are positive for CRP 3. Subjects who have been advised by a doctor not to exercise 4. Subjects who cannot conduct FCD due to some kind of locomotorium disability 5. Subjects who have been judged by a doctor to not be suitable to participate in the study
Target sample size	40

Research contact person
Name of lead principal investigator	1st name Miki Middle name Last name Tachiyama
Organization	MIKI FUNIT Co., Ltd.
Division name	Head office
Zip code	819-0005
Address	1-7-2-2F, Uchihama, Nishi-ku, Fukuoka
TEL	092-407-2530
Email	m.tachiyama@mikifunnit.com

Public contact
Name of contact person	1st name Megumi Middle name Last name Shimazu
Organization	MIKI FUNIT Co., Ltd.
Division name	Head office
Zip code	819-0005
Address	1-7-2-2F, Uchihama, Nishi-ku, Fukuoka
TEL	092-407-2530
Homepage URL
Email	m.shimazu@mikifunnit.com

Sponsor
Institute	MIKI FUNIT Co., Ltd.
Institute
Department

Funding Source
Organization	Japan Sports Agency
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	Boocs Clinic Fkuoka
Address	6-18-6F, tenyamachi, Hakata-ku, Fukuoka
Tel	6-18-6F, tenyamachi, Hakata-ku, Fukuoka6-18-6F, te
Email	fukuoka@boocsclinic.com

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	社会医療法人栄光会　栄光会ファミリークリニック（福岡県）

Other administrative information
Date of disclosure of the study information	2021 Year 09 Month 06 Day

Related information
URL releasing protocol
Publication of results	Published

Result
URL related to results and publications	https://sportinlife.go.jp/pdf/offer_final/08_1.pdf
Number of participants that the trial has enrolled	33
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	2020 Year 11 Month 17 Day
Date of IRB	2020 Year 11 Month 17 Day
Anticipated trial start date	2020 Year 11 Month 18 Day
Last follow-up date	2021 Year 01 Month 18 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date	2021 Year 09 Month 06 Day
Last modified on	2021 Year 09 Month 06 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000049090