UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000001488 |
|---|---|
| Receipt number | R000001806 |
| Scientific Title | A randomised controlled trial of exercise class for older persons with mild depression |
| Date of disclosure of the study information | 2008/11/09 |
| Last modified on | 2008/11/08 07:43:18 |
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Basic information
Public title
A randomised controlled trial of exercise class for older persons with mild depression
Acronym
Effects of exercise class on older persons with mild depression
Scientific Title
A randomised controlled trial of exercise class for older persons with mild depression
Scientific Title:Acronym
Effects of exercise class 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 exercise itself without any effect of being socialized or group dynamics.
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 10 weeks
Key secondary outcomes
HAM-D assessment is performed for the intervention group 10 weeks and 6 months 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
Placebo
Stratification
YES
Dynamic allocation
NO
Institution consideration
Institution is considered as a block.
Blocking
YES
Concealment
Central registration
Intervention
No. of arms
3
Purpose of intervention
Treatment
Type of intervention
| Behavior,custom |
Interventions/Control_1
low-intensity exercise class for 1 hour each week for 10 weeks
Interventions/Control_2
being asked to spend normal lifes
Interventions/Control_3
life review for 1 hour each week for 10 weeks
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
| 60 | years-old | <= |
Age-upper limit
| 86 | years-old | > |
Gender
Male and Female
Key inclusion criteria
Community dwellers with mild depression, which is definded as dysthimia or minor depression in accordance with DSM-IV.
Key exclusion criteria
Subjects are excluded if they express suicidal ideation. Other exclusion criteria are 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
90
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(.2417)
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(.2417)
Homepage URL
ihara1@med.toho-u.ac.jp
Sponsor or person
Institute
Toho University School of Medicine, Department of Social Medicine, Division of Public Health
Institute
Department
Personal name
Funding Source
Organization
Japan
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)
IRB Contact (For public release)
Organization
Address
Tel
Secondary IDs
Secondary IDs
YES
Study ID_1
19001
Org. issuing International ID_1
Toho University School of Medicine
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
Other administrative information
Date of disclosure of the study information
| 2008 | Year | 11 | Month | 09 | 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
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
Date of protocol fixation
| 2006 | Year | 04 | Month | 21 | Day |
Date of IRB
Anticipated trial start date
| 2007 | Year | 08 | Month | 01 | Day |
Last follow-up date
| 2010 | Year | 05 | Month | 01 | Day |
Date of closure to data entry
| 2010 | Year | 05 | Month | 01 | Day |
Date trial data considered complete
| 2010 | Year | 09 | Month | 01 | Day |
Date analysis concluded
| 2011 | Year | 09 | Month | 01 | Day |
Other
Other related information
Management information
Registered date
| 2008 | Year | 11 | Month | 08 | Day |
Last modified on
| 2008 | Year | 11 | Month | 08 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000001806
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
