UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000042539
Receipt number R000048558
Scientific Title Integration of Dual-task Training into Occupations in Older people
Date of disclosure of the study information 2020/11/26
Last modified on 2023/06/04 18:16:48

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Basic information

Public title

Integration of Dual-task Training into Daily Living in Older people

Acronym

IDTOO

Scientific Title

Integration of Dual-task Training into Occupations in Older people

Scientific Title:Acronym

IDTOO

Region

Japan


Condition

Condition

Community-dwelling older people

Classification by specialty

Adult

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

The purpose of this study was to examine the effect of dual tasks combining occupational and cognitive tasks on attention, memory, and health-related quality of life (QOL) among community-dwelling older people.

Basic objectives2

Safety,Efficacy

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

Raw scores of the logical memory I and II subscales of the Wechsler Memory Scale-Revised (WMS-R)

Key secondary outcomes

Visual Cancellation Task, a subscale of the Clinical Assessment for Attention (CAT), Symbol Digit Modalities Test (SDMT), Center for Epidemiologic Studies Depression Scale (CES-D), and 36-Item


Base

Study type

Interventional


Study design

Basic design

Single arm

Randomization

Non-randomized

Randomization unit


Blinding

Open -no one is blinded

Control

Uncontrolled

Stratification


Dynamic allocation


Institution consideration


Blocking


Concealment



Intervention

No. of arms

1

Purpose of intervention

Prevention

Type of intervention

Behavior,custom

Interventions/Control_1

We decide on an intervention integrating cognitive tasks through the following procedures that the participants undergo: (1) listing five highly important occupation names and occupational areas, (2) selecting cognitive task(s), and (3) selecting an occupation into which cognitive task(s) can be integrated. Participants perform an occupation that integrated a cognitive task for six months, in a home-based environment. The intervention period last for 6 months.

Interventions/Control_2


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

The inclusion criteria require that participants be aged a minimum of 65 years, and that they be capable of communication.

Key exclusion criteria

Exclusion criteria apply to people who had been diagnosed with dementia, were regularly going to fitness centers, and were following structured exercise programs.

Target sample size

15


Research contact person

Name of lead principal investigator

1st name katsushi
Middle name
Last name Yokoi

Organization

Osaka prefecture University

Division name

Graduate School of Comprehensive Rehabilitation

Zip code

583-8555

Address

3-7-30 Habikino, Habikino-City, Osaka 583-8555, JAPAN

TEL

072-950-2111

Email

yokoik@rehab.osakafu-u.ac.jp


Public contact

Name of contact person

1st name Katsushi
Middle name
Last name Yokoi

Organization

Osaka prefecture University

Division name

Graduate School of Comprehensive Rehabilitation

Zip code

583-8555

Address

3-7-30 Habikino, Habikino-City, Osaka 583-8555, JAPAN

TEL

072-950-2111

Homepage URL


Email

yokoik@rehab.osakafu-u.ac.jp


Sponsor or person

Institute

Osaka prefecture University

Institute

Department

Personal name



Funding Source

Organization

Ministry of Education, Culture, Sports, Science and Technology

Organization

Division

Category of Funding Organization

Japanese Governmental office

Nationality of Funding Organization



Other related organizations

Co-sponsor


Name of secondary funder(s)



IRB Contact (For public release)

Organization

Morinomiya University of Medical Sciences ethics committee

Address

1-26-16 Nankokita, Suminoe-ku, Osaka-shi, Osaka 559-8611, JAPAN

Tel

06-6616-6911

Email

shinsabukai@morinomiya-u.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

2020 Year 11 Month 26 Day


Related information

URL releasing protocol

https://doi.org/10.32191/jjos.15.008

Publication of results

Unpublished


Result

URL related to results and publications

https://doi.org/10.32191/jjos.15.008

Number of participants that the trial has enrolled

15

Results

All participants were able to complete the intervention with no adverse effects. Indicators that showed significant improvement before and after the intervention were logical memory II (p < 0.01, effect size = 0.58), Position Stroop test (p = 0.03, effect size = 0.53), CES-D (p < 0.01, effect size = 1.00), CAS (p = 0.04, effect size = 0.49), and social life function (p = 0.04, effect size = 0.53).

Results date posted

2023 Year 06 Month 04 Day

Results Delayed


Results Delay Reason


Date of the first journal publication of results


Baseline Characteristics

15 participants (mean age 75.9 plus-minus 6.4 years, 10 males and 5 females). Two participants lived alone.

Participant flow

In a public relations magazine published by a community comprehensive care center, we published an invitation for community-dwelling older adults who lived independently to participate in this research. They were recruited from two communities, and all participants attended local volunteer meetings.

Adverse events

All participants completed the six-month intervention without experiencing any adverse events.

Outcome measures

For the main study outcome, we used the raw scores of the subscales logical memory I and II of the Wechsler Memory Scale-Revised (WMS-R), often used in previous studies involving individuals with mild cognitive impairment (Donohue et al., 2014; Mormino et al., 2017). Additionally, we used the Symbol Digit Modalities Test (SDMT; Smith, 1973) of the Clinical Assessment for Attention (Sohlberg & Mateer, 1986), the Center for Epidemiologic Studies Depression Scale (CES-D; Radloff, 1977), and the 36-item Short-Form Health Survey (SF-36; Fukuhara et al., 1998a, 1998b).

Plan to share IPD


IPD sharing Plan description



Progress

Recruitment status

No longer recruiting

Date of protocol fixation

2018 Year 04 Month 01 Day

Date of IRB

2018 Year 05 Month 29 Day

Anticipated trial start date

2019 Year 02 Month 01 Day

Last follow-up date

2021 Year 03 Month 31 Day

Date of closure to data entry


Date trial data considered complete


Date analysis concluded



Other

Other related information



Management information

Registered date

2020 Year 11 Month 24 Day

Last modified on

2023 Year 06 Month 04 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000048558


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name