UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000045877 |
|---|---|
| Receipt number | R000052375 |
| Scientific Title | Effects of Exercise Therapy on Bipolar Depression |
| Date of disclosure of the study information | 2021/12/01 |
| Last modified on | 2022/09/28 17:36:10 |
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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
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
fukuoka2310@gmail.com
Sponsor or person
Institute
Faculty of medicine, Fukuoka University
Institute
Department
Personal name
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
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
Open public recruiting
Date of protocol fixation
| 2021 | Year | 12 | Month | 01 | Day |
Date of IRB
| 2022 | Year | 01 | Month | 24 | Day |
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
| 2022 | Year | 09 | Month | 28 | Day |
Link to view the page
Value
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 | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
