UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000040104 |
|---|---|
| Receipt number | R000045163 |
| Scientific Title | Individualized treatment of mood disorders by exercise therapy based on cardiopulmonary exercise test (CPX) indices |
| Date of disclosure of the study information | 2020/04/13 |
| Last modified on | 2024/04/15 15:10:21 |
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Basic information
Public title
Individualized treatment of mood disorders by exercise therapy based on cardiopulmonary exercise test (CPX) indices
Acronym
Individualized treatment of mood disorders by exercise therapy based on CPX indices
Scientific Title
Individualized treatment of mood disorders by exercise therapy based on cardiopulmonary exercise test (CPX) indices
Scientific Title:Acronym
Individualized treatment of mood disorders by exercise therapy based on CPX indices
Region
| Japan |
Condition
Condition
Mood disorder
Classification by specialty
| Psychiatry |
Classification by malignancy
Others
Genomic information
YES
Objectives
Narrative objectives1
As an exploratory pilot study, the purpose of the present trial is to examine the effectiveness of a physical exercise program based on cardiopulmonary exercise testing (CPX) in treating mood disorders including depression. Furthermore, the present study also investigate what factors can predict the effectiveness of the exercise program.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Assessment
Primary outcomes
Depressive symptoms evaluated at the beginning and after eight weeks of the intervention by the Structured Interview Guide for the Hamilton Depression Rating Scale (SIGH-D)
Key secondary outcomes
1) Self-report depressive symptoms evaluated by BDI-II
2) Other mental status evaluations (including anxiety, social adaptation, and psychological wellbeing), and neuropsychiatric tests (including working memory, reinforcement learning, and creativity), etc.
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
YES
Dynamic allocation
NO
Institution consideration
Institution is not considered as adjustment factor.
Blocking
YES
Concealment
Central registration
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Behavior,custom |
Interventions/Control_1
A physical exercise intervention for 8 weeks will be given to the subjects in the exercise group. There are no restrictions on drug or psychotherapy treatments. The physical exercise intervention consists of two supervised sessions per week for eight consecutive weeks. Each session lasts roughly one hour and includes 20 minutes of preparatory exercises (warming-up) such as stretching, 30 minutes of cycling using an ergometer, and 10 minutes of cool-down exercises. The 30 minutes of cycling further include 5 minutes of warm-up cycling and 25 minutes of main episode cycling conducted at an intensity that approaches but never goes higher than subjects' anaerobic metabolic threshold (AT: exercise intensity at which oxygen cannot be supplied to muscles) calculated based on the cardiopulmonary exercise testing (CPX). Meanwhile, the intensity of the cycling is further moderated in a way such that subjects' perceived exertion stay no higher than 13 (somewhat hard) as evaluated by the Borg Rating of Perceived Exertion Scale. Each session is then finalized by a 10-minute cool-down stretching exercise. At the first and fifth weeks, there is a 10-minute exercise instruction session conducted by an occupational therapist.
Interventions/Control_2
Control subjects in the wait-list group will be enrolled in the physical exercise intervention list, which will be administered 8 weeks later. Control subjects will receive regular treatment and are instructed to maintain their lifestyle during these 8 weeks before starting the physical exercise intervention. There are no restrictions on drug or psychotherapy treatments.
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
| 61 | years-old | > |
Gender
Male and Female
Key inclusion criteria
1) Patients diagnosed as "Depressive Disorders" or "Bipolar and Related Disorders" according to the Diagnostic and Statistical Manual of Mental Disorders, 5th ed. (DSM-5). Patients in the "Depressive Disorders" are restricted to those who have used one or more antidepressants but have not achieved remission (Hamilton Depression Rating Scale (HAM-D) 17-item version score is greater than or equal to 8).
2) Those who are at least 20 years old and under 61 years old at the time of obtaining consent.
3) Irrespective of gender.
4) Patients who are able to provide a written informed consent after being explained the details of the study.
Key exclusion criteria
1) Strong suicidal thoughts.
2) Patients who score five or more on the Young Manic Rating Scale (YMRS).
3) Patients with active inflammatory disease.
4) Patients with malignant tumor.
5) Patients who cannot exercise, for example, due to orthopedic disease or body weight exceeding the allowance of the ergometer.
6) Patients who have already been performing regular physical exercise.
7) Others subjects who are considered inappropriate for this study (e.g., being pregnant or possibly pregnant).
Target sample size
120
Research contact person
Name of lead principal investigator
| 1st name | Shin |
| Middle name | |
| Last name | Nakagawa |
Organization
Yamaguchi University Graduate School of Medicine
Division name
Division of Neuropsychiatry, Department of Neuroscience
Zip code
7558505
Address
Minami-kogushi 1-1-1, Ube, Yamaguchi 7558505
TEL
0836-22-2255
brain@yamaguchi-u.ac.jp
Public contact
Name of contact person
| 1st name | Chong |
| Middle name | |
| Last name | Chen |
Organization
Yamaguchi University Graduate School of Medicine
Division name
Division of Neuropsychiatry, Department of Neuroscience
Zip code
7558505
Address
Minami-kogushi 1-1-1, Ube, Yamaguchi 7558505
TEL
0836-22-2255
Homepage URL
brain@yamaguchi-u.ac.jp
Sponsor or person
Institute
Division of Neuropsychiatry, Department of Neuroscience, Yamaguchi University Graduate School of Medicine
Institute
Department
Personal name
Funding Source
Organization
Grant-in-Aid for Scientific Research (C) supported by the Japanese Ministry of Education, Culuture, Sports, Science and Technology (MEXT)
Organization
Division
Category of Funding Organization
Japanese Governmental office
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
Department of Biostatistics, Yamaguchi University Graduate School of Medicine
Department of Radiology, Yamaguchi University Graduate School of Medicine
Faculty of Health Sciences, Yamaguchi University Graduate School of Medicine
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Center For Clinical Research, Yamaguchi University Hospital
Address
Minami-kogushi 1-1-1, Ube, Yamaguchi 7558505
Tel
0836-22-2428
clin_res@yamaguchi-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
山口大学医学部附属病院
Other administrative information
Date of disclosure of the study information
| 2020 | Year | 04 | Month | 13 | 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
| 2020 | Year | 04 | Month | 10 | Day |
Date of IRB
| 2020 | Year | 03 | Month | 11 | Day |
Anticipated trial start date
| 2021 | Year | 04 | Month | 01 | Day |
Last follow-up date
| 2026 | Year | 08 | Month | 31 | Day |
Date of closure to data entry
| 2026 | Year | 09 | Month | 30 | Day |
Date trial data considered complete
| 2026 | Year | 09 | Month | 30 | Day |
Date analysis concluded
| 2027 | Year | 03 | Month | 31 | Day |
Other
Other related information
Management information
Registered date
| 2020 | Year | 04 | Month | 08 | Day |
Last modified on
| 2024 | Year | 04 | Month | 15 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000045163
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