UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000025431 |
|---|---|
| Receipt number | R000029144 |
| Scientific Title | The effects of exercise based on cadiopulmonary exercise training (CPX) in depression and exploring the mechanisms involved in the effects on PBMC mitochondria of depression |
| Date of disclosure of the study information | 2017/01/01 |
| Last modified on | 2018/07/04 08:49:44 |
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Basic information
Public title
The effects of exercise based on cadiopulmonary exercise training (CPX) in depression and exploring the mechanisms involved in the effects on PBMC mitochondria of depression
Acronym
effects of exercise based on CPX in depression
Scientific Title
The effects of exercise based on cadiopulmonary exercise training (CPX) in depression and exploring the mechanisms involved in the effects on PBMC mitochondria of depression
Scientific Title:Acronym
effects of exercise based on CPX in depression
Region
| Japan |
Condition
Condition
major depressive disorder, persistent depressive disorder
Classification by specialty
| Psychiatry |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The aim of this study is to investigate whether the exercise based on CPX has benefit for the treatment of major depressive and persistent depressive disorders, and wether the exercise reduces an oxidative stress derived from PBMC mitochondria.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
amount of change in HAM-D before and 8,16 weeks after exercise sessions
Key secondary outcomes
1.amount of change in bech sub scale before and 8,16 weeks after exercise sessions
2.amount of change in CGI-S before and 8,16 weeks after exercise sessions
3.amount of change in BDI-2 before and 8,16 weeks after exercise sessions
4.amount of change in STAI before and 8,16 weeks after exercise sessions
5.amount of change in PSQI before and 8,16 weeks after exercise sessions
6.amount of change in SF-36v2 before and 8,16 weeks after exercise sessions
7.amount of change in SASS before and 8,16 weeks after exercise sessions
8.amount of change in cognitive function test before and 8,16 weeks after exercise sessions
9.amount of change in data for actigraphy and lifecoda before and 8,16 weeks after exercise sessions
10.amount of change in CPX before and 16 weeks after exercise sessions
11.amount of change in somatometry before and 16 weeks after exercise sessions
12.amount of change in biochemical marker in blood before and 16 weeks after exercise sessions
13.amount of change in function of PBMC mitochondria before and 16 weeks after exercise sessions
14.amount of change in biochemical marker in urine before and 16 weeks after exercise sessions15.assessment in relapse after 1 year
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
Treatment
Type of intervention
| Maneuver |
Interventions/Control_1
The exercise bikes are used as exercise intervention for 30 min, twice a week, 16 weeks.
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
| 61 | years-old | > |
Gender
Male and Female
Key inclusion criteria
The participants are recruited from the outpatients at Hokkaido University Hospital, and diagnosed as major depressive disorder or persistent depressive disorder according to DSM-5.
Key exclusion criteria
1. Patients with severe depression (HAM-D score 20 or more)
2. Patients expressing serious suicidal thoughts
3. Patients with YMRS score 13 or more
4. Patients with inflammatory disease
5. Patients with malignant tumor
6. Patients who can't take exercise using exercise bike due to orthopedic disease
7. Patients who have usually take exercise at fixed intervals
8. Patients treated with dialysis for chronic renal failure
9. patients whom principal investigators consider are not eligible
Target sample size
15
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Ichiro kusumi |
Organization
Hokkaido University Graduate School of Medicine
Division name
Psychiatry
Zip code
Address
kita 15 Nishi 7, kita-ku, Sapporo, Japan
TEL
011-706-5160
ikusumi@med.hokudai.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Shin Nakagawa |
Organization
Hokkaido University Graduate School of Medicine
Division name
Psychiatry
Zip code
Address
kita 15 Nishi 7, kita-ku, Sapporo, Japan
TEL
011-706-5160
Homepage URL
snakaga@med.hokudai.ac.jp
Sponsor or person
Institute
Hokkaido University
Institute
Department
Personal name
Funding Source
Organization
Ministry of Education, Culture, Sports, Science and Technology
Organization
Division
Category of Funding Organization
Japanese Governmental office
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Address
Tel
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
北海道大学病院（北海道）
Other administrative information
Date of disclosure of the study information
| 2017 | Year | 01 | 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
We developed an exercise program based on patients' individual level of anaerobic threshold, a submaximal index of aerobic capacity measured by cardiopulmonary exercise testing. We found that in patients diagnosed with major depressive disorder or persistent depressive disorder, our exercise program resulted in a clinically significant reduction in depressive symptoms at week 8, which was maintained at week 16.
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
| 2016 | Year | 12 | Month | 06 | Day |
Date of IRB
Anticipated trial start date
| 2017 | Year | 01 | Month | 15 | Day |
Last follow-up date
| 2018 | Year | 08 | Month | 01 | Day |
Date of closure to data entry
| 2018 | Year | 08 | Month | 01 | Day |
Date trial data considered complete
| 2018 | Year | 08 | Month | 01 | Day |
Date analysis concluded
| 2018 | Year | 08 | Month | 01 | Day |
Other
Other related information
Management information
Registered date
| 2016 | Year | 12 | Month | 27 | Day |
Last modified on
| 2018 | Year | 07 | Month | 04 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000029144
