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

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 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


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

Value
https://center6.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