UMIN-CTR Clinical Trial

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

Post - Stroke Depression

Classification by specialty

Neurology	Geriatrics	Psychiatry

Classification by malignancy

Others

Genomic information

NO

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

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.

Study type

Interventional

Basic design

Parallel

Randomization

Randomized

Randomization unit

Individual

Blinding

Open -but assessor(s) are blinded

Control

Active

Stratification

Dynamic allocation

Institution consideration

Blocking

Concealment

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

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

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

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

Institute

University of Tsukuba

Institute

Department

Personal name

Organization

Graduate School of Comprehensive Human Sciences, University of Tsukuba

Organization

Division

Category of Funding Organization

Other

Nationality of Funding Organization

Co-sponsor

Name of secondary funder(s)

Organization

Address

Tel

Email

Secondary IDs

NO

Study ID_1

Org. issuing International ID_1

Study ID_2

Org. issuing International ID_2

IND to MHLW

Institutions

Date of disclosure of the study information

2018

Year

03

Month

15

Day

URL releasing protocol

Publication of results

Unpublished

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

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 related 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