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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000045877
Receipt No. R000052375
Scientific Title Effects of Exercise Therapy on Bipolar Depression
Date of disclosure of the study information 2021/12/01
Last modified on 2021/10/26

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Basic information
Public title Effects of Exercise Therapy on Bipolar Depression
Acronym Clinical Exercise Research in Fukuoka University (CERF-BD)
Scientific Title Effects of Exercise Therapy on Bipolar Depression
Scientific Title:Acronym Clinical Exercise Research in Fukuoka University (CERF-BD)
Region
Japan

Condition
Condition bipolar depression
Classification by specialty
Psychiatry
Classification by malignancy Others
Genomic information YES

Objectives
Narrative objectives1 The aim of this study will be to investigate whether the implementation of an exercise program will improve the social functions of patients with bipolar disorder
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes functioning assessment short test
Key secondary outcomes

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Cluster
Blinding Double blind -all involved are blinded
Control Placebo
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Other
Interventions/Control_1 exercise program
Interventions/Control_2 stretch
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
65 years-old >=
Gender Male and Female
Key inclusion criteria 1)diagnosis of bipolar disorder according to DSM-5
2)current depressive episode
3)QIDS-J between 6 and 15 score
4)age between 20 and 65 years old and patients provided written informed consent
Key exclusion criteria 1) diagnosis of mental retardation according to DSM-5
2)history of cranial trauma with loss of consciousness
3)severe medical conditions including cardiovascular disease, liver disease, and kidney disease
4)pregnancy or breastfeeding
5)current severe depression (QIDS-J>15)
6)significant medical conditions interfering with exercise
7)others
Target sample size 100

Research contact person
Name of lead principal investigator
1st name Hiroaki
Middle name
Last name Kawasaki
Organization Faculty of medicine, Fukuoka University
Division name Department of Psychiary
Zip code 8140180
Address 7-45-1 Nanakuma, Jonan-ku, Fukuoka city
TEL 0928011011
Email fukuoka2310@gmail.com

Public contact
Name of contact person
1st name Fumito
Middle name
Last name Hamada
Organization Faculty of medicine, Fukuoka University
Division name Department of Psychiary
Zip code 814
Address 7-45-1 Nanakuma, Jonan-ku, Fukuoka city
TEL 09037980802
Homepage URL
Email fukuoka2310@gmail.com

Sponsor
Institute Faculty of medicine, Fukuoka University
Institute
Department

Funding Source
Organization Faculty of medicine, Fukuoka University
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 Faculty of medicine, Fukuoka University
Address 7-45-1 Nanakuma, Jonan-ku, Fukuoka city
Tel 0928011011
Email fumed-ethics@fukuoka-u.ac.jp

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
2021 Year 12 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
2021 Year 12 Month 01 Day
Date of IRB
Anticipated trial start date
2021 Year 12 Month 01 Day
Last follow-up date
2024 Year 03 Month 31 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 10 Month 26 Day
Last modified on
2021 Year 10 Month 26 Day


Link to view the page
URL(English) https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000052375

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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