UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000045394 |
|---|---|
| Receipt number | R000049090 |
| Scientific Title | A study of the effects of FCD (Freedom Collaboration Dance) on brain fatigue |
| Date of disclosure of the study information | 2021/09/06 |
| Last modified on | 2021/09/06 16:06:50 |
* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments
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
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
m.shimazu@mikifunnit.com
Sponsor or person
Institute
MIKI FUNIT Co., Ltd.
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000049090
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
|---|---|
| Registered date | File name |
| Research case data | |
|---|---|
| Registered date | File name |
