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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000029117
Receipt No. R000033266
Scientific Title The Effect of Cognitive Rehabilitation vs. Low Intensity Exercise for Post - Stroke Depression in Long - Term Care Health Facilities: a randomized controlled trial
Date of disclosure of the study information 2018/03/15
Last modified on 2018/03/15

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Basic information
Public title The Effect of Cognitive Rehabilitation vs. Low Intensity Exercise for Post - Stroke Depression in Long - Term Care Health Facilities: a randomized controlled trial
Acronym The Effect of Cognitive Rehabilitation vs. Low Intensity Exercise for Post - Stroke Depression in Long - Term Care Health Facilities: a randomized controlled trial
Scientific Title The Effect of Cognitive Rehabilitation vs. Low Intensity Exercise for Post - Stroke Depression in Long - Term Care Health Facilities: a randomized controlled trial
Scientific Title:Acronym The Effect of Cognitive Rehabilitation vs. Low Intensity Exercise for Post - Stroke Depression in Long - Term Care Health Facilities: a randomized controlled trial
Region
Japan

Condition
Condition Post - Stroke Depression
Classification by specialty
Neurology Geriatrics Psychiatry
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 The purpose of the present study was to examine the effects of the cognitive rehabilitation on the cognitive function, ADL, and QOL in Post-Stroke Depression (PSD) patients. In addition, we examined the effects of cognitive rehabilitation on customer satisfaction in long-terms care facility service and rehabilitation.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes The measurement was performed before the rehabilitation sessions (initial evaluation) and after the 36 sessions (post-training evaluation). Primary outcome measures were evaluations for Japan Stroke Scale (Depression and Emotional Disturbance Scale) (JSS-DE)).
Key secondary outcomes Secondary outcome measures included severity scores of depression (the Geriatric Depression Scale (GDS), Zung Self Depression Scale (SDS), cognitive function (Frontal Assessment Battery (FAB)), ADL, and Rehabilitation Customer Satisfaction (The Customer Satisfaction Scale based on Need Satisfaction (CSSNS)) and Facility Service Satisfaction.

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Individual
Blinding Open -but assessor(s) are blinded
Control Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Maneuver
Interventions/Control_1 PSD patients were given 36 rehabilitation sessions that the addition of cognitive rehabilitation (intervention group) to a typical rehabilitation program (three sessions a week for twelve weeks).
Interventions/Control_2 PSD patients were given 36 rehabilitation sessions that the typical rehabilitation (control group)(three sessions a week for twelve weeks).
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
40 years-old <=
Age-upper limit
95 years-old >=
Gender Male and Female
Key inclusion criteria The inclusion criteria were as follows: 1) cerebral infarction or, there is a history of cerebrovascular disorders such as cerebral hemorrhage, 2) mood disorders person who falls two or more certain symptoms according to Diagnostic and Statistical Manual of Mental Disorders fourth edition (DSM-IV) in item category, 3) depression state both in the Geriatric Depression Scale (GDS) (more than 5 points), Zung Self Depression Scale (SDS) (40-59 points, mild depression), Japan Stroke Scale (Depression Scale) (JSS-D) (2.4 points or more) was determined to be depression.
Key exclusion criteria Exclusion criteria were as follows: 1) taking any anti-depressants , 2) dementia with Hasegawa dementia rating scale-revised (HDS-R) (10 points or less) , or Independence degree of daily living for the demented elderly (rank IV-M), 3) subjects with higher brain dysfunction such as aphasis.
Target sample size 30

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Yanagi Hisako
Organization University of Tsukuba
Division name Department of Medical Science and Welfare, Faculty of Medicine
Zip code
Address 1-1-1 Tennodai, Tsukuba, Ibaraki 305-8577 Japan
TEL 029-853-3496
Email hyanagi@md.tsukuba.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Harumi Sakamoto
Organization Graduate School of Comprehensive Human Sciences, University of Tsukuba
Division name Department of Medical Science and Welfare
Zip code
Address 1-1-1 Tennodai, Tsukuba, Ibaraki 305-8577 Japan
TEL 029-853-3496
Homepage URL
Email hsakamoto131@gmail.com

Sponsor
Institute University of Tsukuba
Institute
Department

Funding Source
Organization Graduate School of Comprehensive Human Sciences, University of Tsukuba
Organization
Division
Category of Funding Organization Other
Nationality of Funding Organization

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

Other administrative information
Date of disclosure of the study information
2018 Year 03 Month 15 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 Completed
Date of protocol fixation
2015 Year 07 Month 01 Day
Date of IRB
Anticipated trial start date
2015 Year 08 Month 01 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2017 Year 09 Month 12 Day
Last modified on
2018 Year 03 Month 15 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000033266

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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