UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000057681
Receipt number R000065882
Scientific Title Effectiveness of Dual-Task Training in Preventing Attention Decline Among Older Adults Living in Kagamiishi Town: A Randomized Controlled Trial
Date of disclosure of the study information 2025/06/30
Last modified on 2025/06/08 14:41:56

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Basic information

Public title

Effectiveness of Dual-Task Training in Preventing Attention Decline Among Community-Dwelling Older Adults: A Randomized Controlled Trial

Acronym

Effectiveness of Dual-Task Training in Preventing Attention Decline Among Community-Dwelling Older Adults: A Randomized Controlled Trial

Scientific Title

Effectiveness of Dual-Task Training in Preventing Attention Decline Among Older Adults Living in Kagamiishi Town: A Randomized Controlled Trial

Scientific Title:Acronym

Effectiveness of Dual-Task Training in Preventing Attention Decline Among Community-Dwelling Older Adults: A Randomized Controlled Trial

Region

Japan


Condition

Condition

Healthy older adults

Classification by specialty

Not applicable Adult

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

To examine the effectiveness of dual-task training in preventing attention decline among community-dwelling older adults.

Basic objectives2

Efficacy

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

Attentional function (Trail making test Japanese: TMT-J)

Key secondary outcomes

Attentional function(Digit span test, Stroop and reverse stroop test)
Balance function (Timed up and go test: TUG, Eyes-open and eyes-closed single-leg stance time)
the Attention Dysfunction While Driving and Walking Scales


Base

Study type

Interventional


Study design

Basic design

Parallel

Randomization

Randomized

Randomization unit

Individual

Blinding

Open -but assessor(s) are blinded

Control

No treatment

Stratification


Dynamic allocation


Institution consideration


Blocking


Concealment



Intervention

No. of arms

2

Purpose of intervention

Prevention

Type of intervention

Behavior,custom

Interventions/Control_1

Intervention group: receive dual-task training for 1 hour per session, twice a week, for 4 weeks.

Interventions/Control_2

Control group: continue their usual daily life for 4 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

65 years-old <=

Age-upper limit

80 years-old >=

Gender

Male and Female

Key inclusion criteria

Individuals who can complete the TMT-A without errors and within 40 to 80 seconds.
Individuals who are expected to be available to participate in the intervention twice a week for four weeks.
Individuals who have given their consent to participate in this study.

Key exclusion criteria

Individuals who have been restricted from exercising by a physician.

Target sample size

60


Research contact person

Name of lead principal investigator

1st name Maki
Middle name
Last name Ogasawara

Organization

Fukushima Medical University

Division name

Department of Occupational Therapy, School of Health Sciences

Zip code

960-8516

Address

10-6 Sakaemachi, Fukushima City, Fukushima

TEL

024(581)5553

Email

oga-maki@fmu.ac.jp


Public contact

Name of contact person

1st name Maki
Middle name
Last name Ogasawara

Organization

Fukushima Medical University

Division name

Department of Occupational Therapy, School of Health Sciences

Zip code

960-8516

Address

10-6 Sakaemachi, Fukushima City, Fukushima

TEL

024(581)5553

Homepage URL


Email

oga-maki@fmu.ac.jp


Sponsor or person

Institute

Fukushima Medical University

Institute

Department

Personal name

Maki Ogasawara


Funding Source

Organization

Japan Society for the Promotion of Science

Organization

Division

Category of Funding Organization

Japanese Governmental office

Nationality of Funding Organization

Japan


Other related organizations

Co-sponsor


Name of secondary funder(s)

Kagamiishi Town


IRB Contact (For public release)

Organization

Fukushima Medical University General Ethics Committee

Address

1 Hikariga-oka, Fukushima City, Fukushima

Tel

024(547)1825

Email

fmurec@fmu.ac.jp


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

2025 Year 06 Month 30 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

Preinitiation

Date of protocol fixation

2025 Year 02 Month 28 Day

Date of IRB

2025 Year 04 Month 16 Day

Anticipated trial start date

2025 Year 09 Month 25 Day

Last follow-up date

2025 Year 10 Month 30 Day

Date of closure to data entry


Date trial data considered complete


Date analysis concluded



Other

Other related information



Management information

Registered date

2025 Year 04 Month 22 Day

Last modified on

2025 Year 06 Month 08 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000065882