UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000023083
Receipt number R000026488
Scientific Title Effects of group physical activity based on brain-activating rehabilitation for dementia in geriatric health service facilities
Date of disclosure of the study information 2016/07/08
Last modified on 2022/10/07 09:57:45

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Basic information

Public title

Effects of group physical activity based on brain-activating rehabilitation for dementia in geriatric health service facilities

Acronym

Group physical activity for dementia in geriatric health service facilities

Scientific Title

Effects of group physical activity based on brain-activating rehabilitation for dementia in geriatric health service facilities

Scientific Title:Acronym

Group physical activity for dementia in geriatric health service facilities

Region

Japan


Condition

Condition

Dementia

Classification by specialty

Geriatrics Psychiatry Rehabilitation medicine

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

To determine effects of group physical activity for dementia in geriatric health facilities.

Basic objectives2

Safety,Efficacy

Basic objectives -Others


Trial characteristics_1

Confirmatory

Trial characteristics_2

Pragmatic

Developmental phase



Assessment

Primary outcomes

This study includes some outcomes indicated below after 12 weeks from first intervention sessions.
Change of life space in daily living
Change of physical activity amount level
Change of global cognitive function

Key secondary outcomes



Base

Study type

Interventional


Study design

Basic design

Parallel

Randomization

Randomized

Randomization unit

Individual

Blinding

Single blind -investigator(s) and 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

Participants will be received physical activity on group setting for 45-60 minutes, twice a week, for a 12-week period, in addition be received usual care.

Interventions/Control_2

Participants will not be received intervention from intervention staffs, while they receive assistance of daily living and individualized rehabilitation about twice a week.

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

65 years-old <=

Age-upper limit


Not applicable

Gender

Male and Female

Key inclusion criteria

1. Having dementia with mini-mental statement examination (MMSE) score of 5 to 25,

2. being able to engage in a simple activity or a brief conversation

Key exclusion criteria

1. Having severe auditory and visual impairments,

Target sample size

100


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Tanaka Shigeya

Organization

Takasaki Univesity of Health and Welfare

Division name

Department of Psysical therapy, Faculty of Health care

Zip code


Address

501 Nakaoruicho, Takasaki City, Gunma

TEL

027-352-1291

Email

tanaka-s@takasaki-u.ac.jp


Public contact

Name of contact person

1st name
Middle name
Last name Tanaka Shigeya

Organization

Takasaki University of Health and Welfare

Division name

Department of Physical therapy, Faculty of Health care

Zip code


Address

501 Nakaoruicho, Takasaki City, Gunma

TEL

027-352-1291

Homepage URL


Email

tanaka-s@takasaki-u.ac.jp


Sponsor or person

Institute

Takasaki University of Health and Welfare

Institute

Department

Personal name



Funding Source

Organization

Takasaki University of Health and Welfare

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

2016 Year 07 Month 08 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

2016 Year 07 Month 08 Day

Date of IRB

2016 Year 07 Month 08 Day

Anticipated trial start date

2016 Year 07 Month 08 Day

Last follow-up date

2020 Year 04 Month 01 Day

Date of closure to data entry


Date trial data considered complete


Date analysis concluded



Other

Other related information

2016.8.8 Baseline assessment : 1st period
2016.8.22 Interventions were started : 1st period
2016.11.11 Interventions were completed : 1st period
2016.11.14 Second assessment : 1st period


Management information

Registered date

2016 Year 07 Month 08 Day

Last modified on

2022 Year 10 Month 07 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000026488


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name