Trial Review

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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] 290508 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
aging 300909 0
executive function 301132 0
Condition category
Condition code
Physical Medicine / Rehabilitation 300723 300723 0 0
Physiotherapy
Neurological 300899 300899 0 0
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] 296361 0
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] 300165 0
Executive function, assessed using the Chinese Version of Executive Interview(C-EXIT 25).
Timepoint [1] 300165 0
Before and after intervention
Primary outcome [2] 300309 0
Executive function, assessed using the Trail making test
Timepoint [2] 300309 0
Before and after intervention
Primary outcome [3] 300310 0
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] 300310 0
Before and after intervention
Secondary outcome [1] 329227 0
Physical function, assessed using the Community walking test.
Timepoint [1] 329227 0
Before and after intervention
Secondary outcome [2] 329663 0
Walking ability questionnaire

the items in this questionnaire involves question about knowing how the subjects walking in home, community and shopping mall
Timepoint [2] 329663 0
Before and after intervention
Secondary outcome [3] 330321 0
Executive function, assessed using stroop color and word test

this is another primary outcome
Timepoint [3] 330321 0
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
40
Accrual to date
Final
Recruitment outside Australia
Country [1] 8387 0
Taiwan, Province Of China
State/province [1] 8387 0

Funding & Sponsors
Funding source category [1] 294957 0
University
Name [1] 294957 0
National Yang-Ming University
Country [1] 294957 0
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] 293778 0
None
Name [1] 293778 0
Address [1] 293778 0
Country [1] 293778 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 296320 0
National Yang-Ming University Office of Research and Development
Ethics committee address [1] 296320 0
National Yang-Ming University, 155, Sec. 2, Li-Nong Street,
Shih-Pai, Taipei, Taiwan.
Ethics committee country [1] 296320 0
Taiwan, Province Of China
Date submitted for ethics approval [1] 296320 0
15/06/2016
Approval date [1] 296320 0
10/08/2016
Ethics approval number [1] 296320 0
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 70358 0
Dr Yea-Ru Yang
Address 70358 0
Department of Physical Therapy and Assistive
Technology, National Yang-Ming University, 155, Sec. 2, Li-Nong Street,
Shih-Pai, Taipei, Taiwan.
Country 70358 0
Taiwan, Province Of China
Phone 70358 0
886-2-2826-7000 #7279
Fax 70358 0
Email 70358 0
yryang@ym.edu.tw
Contact person for public queries
Name 70359 0
Miss Yuan-Chen Huang
Address 70359 0
Department of Physical Therapy and Assistive
Technology, National Yang-Ming University, 155, Sec. 2, Li-Nong Street,
Shih-Pai, Taipei, Taiwan.
Country 70359 0
Taiwan, Province Of China
Phone 70359 0
886-2-2826-7000 #7279
Fax 70359 0
Email 70359 0
huj96422@gmail.com
Contact person for scientific queries
Name 70360 0
Dr Yea-Ru Yang
Address 70360 0
Department of Physical Therapy and Assistive
Technology, National Yang-Ming University, 155, Sec. 2, Li-Nong Street,
Shih-Pai, Taipei, Taiwan.
Country 70360 0
Taiwan, Province Of China
Phone 70360 0
886-2-2826-7000 #7279
Fax 70360 0
Email 70360 0
yryang@ym.edu.tw

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
SourceTitleYear of PublicationDOI
EmbaseEffects of Exergame-Based Dual-Task Training on Executive Function and Dual-Task Performance in Community-Dwelling Older People: A Randomized-Controlled Trial.2021https://dx.doi.org/10.1089/g4h.2021.0057
N.B. These documents automatically identified may not have been verified by the study sponsor.