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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000025431
Receipt No. 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

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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
Email 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
Email snakaga@med.hokudai.ac.jp

Sponsor
Institute Hokkaido University
Institute
Department

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
Email

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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000029144

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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