UMIN-CTR Clinical Trial

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
Institute	Takasaki University of Health and Welfare
Institute
Department

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
URL(English)	https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000026488