UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000029117 |
|---|---|
| Receipt number | 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 17:21:51 |
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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
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
hsakamoto131@gmail.com
Sponsor or person
Institute
University of Tsukuba
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000033266
