UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	The Effect of Cognitive Rehabilitation vs. Low Intensity Exercise for Post - Stroke Depression in Long - Term Care Health Facilities: a randomized controlled trial
Title of the study (Brief title)	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	Yanagi Hisako
Organization	University of Tsukuba
Division name	Department of Medical Science and Welfare, Faculty of Medicine
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	Harumi Sakamoto
Organization	Graduate School of Comprehensive Human Sciences, University of Tsukuba
Division name	Department of Medical Science and Welfare
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)

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

Progress
Recruitment status	Completed
Date of protocol fixation	2015 Year 07 Month 01 Day
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

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
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