UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	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
Title of the study (Brief title)	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	Ichiro kusumi
Organization	Hokkaido University Graduate School of Medicine
Division name	Psychiatry
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	Shin Nakagawa
Organization	Hokkaido University Graduate School of Medicine
Division name	Psychiatry
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)

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

Progress
Recruitment status	Completed
Date of protocol fixation	2016 Year 12 Month 06 Day
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

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
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.
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/icdr_e/ctr_view.cgi?recptno=R000029144