ANZCTR - Registration

Registering a new trial?

To achieve prospective registration, we recommend submitting your trial for registration at the same time as ethics submission.

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers

Trial registered on ANZCTR

Registration number

ACTRN12617000095369

Ethics application status

Approved

Date submitted

14/11/2016

Date registered

17/01/2017

Date last updated

27/02/2017

Type of registration

Retrospectively registered

Titles & IDs

Public title

The Effects of Dual-task Training with Exergame on Executive Function and Dual-task Performance in Community-dwelling Older Adults

Scientific title

The Effects of Dual-task Training with Exergame on Executive Function and Dual-task Performance in Community-dwelling Older Adults

Secondary ID [1]

None

Universal Trial Number (UTN)

Trial acronym

Linked study record

Health condition

Health condition(s) or problem(s) studied:

aging

executive function

Condition category

Condition code

Physical Medicine / Rehabilitation

Physiotherapy

Neurological

Studies of the normal brain and nervous system

Intervention/exposure

Study type

Interventional

Description of intervention(s) / exposure

Training
intervention group: Dual-task treadmill training, 3 times/week, total 12 weeks (under physical therapist supervision)

each is an individual one-on-one sessions

The treadmill training include a treadmill to walk on it and a exergame system to provide subjects a dual-task challenge. The training will be supervised under physical therapist at study site. Whole training need about 1 hour to complete.

The content of exergame: When participant is walking on the treadmill they will watch the screen and used their upper extremity to touch the target on the screen. The exergame is made up by x-box kinect system. We used this system to design dual-task training.

Each time when participants of intervention group come we will record it, and make sure the participants complete the required training.

Intervention code [1]

Treatment: Other

Comparator / control treatment

Control group: multi-component exercise 3 times/week, total 12 weeks (home program with video)

These sessions include
1. Warm-up 10 min
2 Aerobic exercise 20 min:
Marching in place, alternate toe touches to front, alternate heel touches, and alternate
toe touches to sides, alternate heel touches to sides, alternate kicks, alternate
knee lifts, and alternate double knee lifts
3 Resistance exercise 10 min:
Sitting: arm side raise, biceps curl, and arm horizontal abduction with elastic band;
double hip abduction with elastic band tied at mid-thigh
4 Balance training 10 min:
Standing: lifting leg forward, backward, sideways, tiptoeing, heel-stand; toe-walking;
side-walking, sitting to standing while holding balls, throwing balls to partner
while standing
5 Cool-down 10 min

We will ask participants to write the training diary to confirm that they complete the exercise

Control group

Active

Outcomes

Primary outcome [1]

Executive function, assessed using the Chinese Version of Executive Interview(C-EXIT 25).

Timepoint [1]

Before and after intervention

Primary outcome [2]

Executive function, assessed using the Trail making test

Timepoint [2]

Before and after intervention

Primary outcome [3]

Dual-task performance

the test is complete by using timed up and go test
two kinds of test
1. motor type: when doing timed up and go test, the subjects hold a cup of water simultaneously
2. cognitive type:when doing timed up and go test, the subjects is given a number by the researcher, and subjects need to calculate this number minus 3 continuously.

Timepoint [3]

Before and after intervention

Secondary outcome [1]

Physical function, assessed using the Community walking test.

Timepoint [1]

Before and after intervention

Secondary outcome [2]

Walking ability questionnaire

the items in this questionnaire involves question about knowing how the subjects walking in home, community and shopping mall

Timepoint [2]

Before and after intervention

Secondary outcome [3]

Executive function, assessed using stroop color and word test

this is another primary outcome

Timepoint [3]

before and after intervention

Eligibility

Key inclusion criteria

1. Age greater than 65 years old (include 65)
2. MMSE more than 24 points (include 24)
3. Able to participate in the intervention
4. no neurological and musculoskeletal disorder
5. no cardiovascular disease
6. no engage in exercise training in 6 months

Minimum age

65 Years

Maximum age

No limit

Sex

Both males and females

Can healthy volunteers participate?

Yes

Key exclusion criteria

1. neurological disease
2. fracture
3. cardiovascular disease

Study design

Purpose of the study

Educational / counselling / training

Allocation to intervention

Randomised controlled trial

Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)

Methods used to generate the sequence in which subjects will be randomised (sequence generation)

Masking / blinding

Blinded (masking used)

Who is / are masked / blinded?

The people assessing the outcomes

Intervention assignment

Other design features

Phase

Type of endpoint/s

Statistical methods / analysis

Recruitment

Recruitment status

Recruiting

Date of first participant enrolment

Anticipated

Actual

12/11/2016

Date of last participant enrolment

Anticipated

Actual

Date of last data collection

Anticipated

Actual

Sample size

Target

Accrual to date

Final

Recruitment outside Australia

Country [1]

Taiwan, Province Of China

State/province [1]

Funding & Sponsors

Funding source category [1]

University

Name [1]

National Yang-Ming University

Address [1]

No.155, Sec.2, Linong Street, Taipei, 112 Taiwan (ROC)

Country [1]

Taiwan, Province Of China

Primary sponsor type

University

Name

Department of Physical Therapy and Assistive Technology, National Yang-Ming University, Taipei, Taiwan

Address

Department of Physical Therapy and Assistive
Technology, National Yang-Ming University, 155, Sec. 2, Li-Nong Street,
Shih-Pai, Taipei, Taiwan

Country

Taiwan, Province Of China

Secondary sponsor category [1]

None

Name [1]

Address [1]

Country [1]

Ethics approval

Ethics application status

Approved

Ethics committee name [1]

National Yang-Ming University Office of Research and Development

Ethics committee address [1]

National Yang-Ming University, 155, Sec. 2, Li-Nong Street,
Shih-Pai, Taipei, Taiwan.

Ethics committee country [1]

Taiwan, Province Of China

Date submitted for ethics approval [1]

15/06/2016

Approval date [1]

10/08/2016

Ethics approval number [1]

YM105064F

Summary

Brief summary

Background: Aging progressively decreases executive function, which results in a reduction of dual-task performance and impacts the ability of older adults to engage in everyday dual-task scenarios. Previous studies reported that multicomponent exercise program improved physical performance in elderly. However, few literatures presents that dual-task training with exergame enhances executive function and dual-task performance which are more close to activities of daily living in older adults.

Purpose: The aim of this study is to investigate effects of dual-task training with exergame on executive function and dual-task performance in community-dwelling older adults.

Methods: Forty community-dwelling people older than 65 years without neurological disorder, heart disease, bone fracture or receiving exercise training in 6 months will be recruited in the present study. They are allocated randomly into either the experimental group accepting dual-task training with exergame three times a week for 12 weeks or control group accepting multicomponent exercise home program three times a week for 12 weeks. Participants receive assessment of executive function, Timed Up and Go with dual-task (motor and cognitive), community walking test, and walking ability questionnaire before and after the intervention.

Statistical analysis: Two-way analysis of variance will be used to analyze dependent variables. The significance will be accepted for values of p<0.05.

Trial website

Trial related presentations / publications

Public notes

Contacts

Principal investigator

Name

Dr Yea-Ru Yang

Address

Department of Physical Therapy and Assistive
Technology, National Yang-Ming University, 155, Sec. 2, Li-Nong Street,
Shih-Pai, Taipei, Taiwan.

Country

Taiwan, Province Of China

Phone

886-2-2826-7000 #7279

Fax

[email protected]

Contact person for public queries

Name

Yuan-Chen Huang

Address

Department of Physical Therapy and Assistive
Technology, National Yang-Ming University, 155, Sec. 2, Li-Nong Street,
Shih-Pai, Taipei, Taiwan.

Country

Taiwan, Province Of China

Phone

886-2-2826-7000 #7279

Fax

[email protected]

Contact person for scientific queries

Name

Yea-Ru Yang

Address

Department of Physical Therapy and Assistive
Technology, National Yang-Ming University, 155, Sec. 2, Li-Nong Street,
Shih-Pai, Taipei, Taiwan.

Country

Taiwan, Province Of China

Phone

886-2-2826-7000 #7279

Fax

[email protected]

No information has been provided regarding IPD availability

What supporting documents are/will be available?

No Supporting Document Provided

Results publications and other study-related documents

Documents added manually

No documents have been uploaded by study researchers.

Documents added automatically

Source	Title	Year of Publication	DOI
Embase	Effects of Exergame-Based Dual-Task Training on Executive Function and Dual-Task Performance in Community-Dwelling Older People: A Randomized-Controlled Trial.	2021	https://dx.doi.org/10.1089/g4h.2021.0057

N.B. These documents automatically identified may not have been verified by the study sponsor.

Trial Review

Registering a new trial?

Documents added manually

Documents added automatically