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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000000887
Receipt No. R000001058
Scientific Title A randomised controlled trial of weekly low-intensity exercise for older persons with mild depression
Date of disclosure of the study information 2007/11/30
Last modified on 2007/11/13

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Basic information
Public title A randomised controlled trial of weekly low-intensity exercise for older persons with mild depression
Acronym Effects of weekly low-intensity exercise on older persons with mild depression
Scientific Title A randomised controlled trial of weekly low-intensity exercise for older persons with mild depression
Scientific Title:Acronym Effects of weekly low-intensity exercise on older persons with mild depression
Region
Japan

Condition
Condition Mild depression
Classification by specialty
Psychiatry
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 The purposes of this study is to evaluate: 1) if weekly low-intensity exercise decreases the severity of psychiatrist-diagnosed mild depression; 2) if the decrease in symptom severity continues after intervention; and 3) if any symptomatic improvement can be attributed to an improvement in physical fitness.
Basic objectives2 Safety
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2 Explanatory
Developmental phase Phase II,III

Assessment
Primary outcomes The 21-item Hamilton Depression Rating Scale (HAM-D) assessed by a psychiatrist in a blinded fashion at 8 weeks
Key secondary outcomes HAM-D assessment was performed for the intervention group 8 weeks after the end of the exercise program

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 No need to know

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Behavior,custom
Interventions/Control_1 low-intensity exercise class for 1 hour each week for 8 weeks
Interventions/Control_2 being asked to spend normal lifes
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
70 years-old <=
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria Community dwellers with mild depression, which was definded as the presence of two or more symptoms of a depressive episode in accordance with the criteria of the International Statistical Classification of Diseases and Related Health Problems, tenth revision (ICD-10).
Key exclusion criteria Subjects were excluded if they expressed suicidal ideation or showed symptoms that met the ICD-10 criteria for moderate or severe depression. Other exclusion criteria were alcoholism, any psychiatric treatment, a score of 23 points or less on the Mini-Mental State Examination, and physical diseases that made exercise inappropriate.
Target sample size 50

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Kazushige Ihara
Organization Toho University School of Medicine, Department of Social Medicine
Division name Division of Public Health
Zip code
Address 5-21-16, Omorinishi, Otaku, Tokyo
TEL 03-3762-4151(ext.2417)
Email

Public contact
Name of contact person
1st name
Middle name
Last name Kazushige Ihara
Organization Toho University School of Medicine, Department of Social medicine
Division name Division of Public Health
Zip code
Address 5-21-16, Omorinishi, Otaku, Tokyo
TEL 03-3762-4151(ext.2417)
Homepage URL http://www.medical.med.toho-u.ac.jp/course/lab/lab_pubhealth.html
Email ihara1@med.toho-u.ac.jp

Sponsor
Institute Toho University School of Medicine, Department of Social Medicine, Division of Public Health
Institute
Department

Funding Source
Organization Japan Foundation for Aging and Health
Organization
Division
Category of Funding Organization
Nationality of Funding Organization Japan

Other related organizations
Co-sponsor Tokyo Metropolitan Institute of Gerontology
Name of secondary funder(s) Ushioda Health Clinic

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

Other administrative information
Date of disclosure of the study information
2007 Year 11 Month 30 Day

Related information
URL releasing protocol
Publication of results Partially published

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 Completed
Date of protocol fixation
2003 Year 08 Month 31 Day
Date of IRB
Anticipated trial start date
2003 Year 12 Month 01 Day
Last follow-up date
2004 Year 12 Month 01 Day
Date of closure to data entry
2005 Year 02 Month 01 Day
Date trial data considered complete
2005 Year 03 Month 01 Day
Date analysis concluded
2005 Year 12 Month 01 Day

Other
Other related information

Management information
Registered date
2007 Year 11 Month 13 Day
Last modified on
2007 Year 11 Month 13 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000001058

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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