Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12616000259448
Ethics application status
Approved
Date submitted
19/02/2016
Date registered
25/02/2016
Date last updated
1/03/2017
Type of registration
Prospectively registered

Titles & IDs
Public title
The effect of video game playing in older adults
Scientific title
The effects of video game playing on cognition, physical ability and sleep in older adults
Secondary ID [1] 288534 0
Nil known
Universal Trial Number (UTN)
Not yet available
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Cognition 297631 0
Physical ability 297632 0
Sleep 297633 0
Condition category
Condition code
Mental Health 297824 297824 0 0
Studies of normal psychology, cognitive function and behaviour

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
This study will involve older adults playing video games in the lab for a duration of 6 weeks with the total training hours of 18. Participants will be allocated into 4 separate groups (i.e. 1 control group, 3 training groups), each with different training intervention. The intervention arms are as follows:

1. Training group 1
The participants in this group will play the Nintendo 3DS Brain Age for an hour, 3
sessions per week over 6 weeks. The participants will play a number of mini game that
emphasizes on memory, mathematical and language abilities using a handheld device,
operated using both touch screen and voice recognition.
2. Training group 2 will play the Nintendo Wii Sports for an hour, 3 sessions per week over 6
weeks. For this game, participants are required to play in accordance with the image in
the screen the using a handheld Wii remote. This remote will control the graphic images
via players' body movement. The Wii sports package includes tennis, bowling, golf,
baseball, and boxing game
3. Training Group 3 will play the Nintendo 3DS Brain Age and Wii Sports for an hour, 3
sessions per week over 6 weeks. For this group, the participants will play Nintendo 3DS
for the first half and Wii Sports for the second half of the training session.

A battery of performance measures, evaluating cognitive and physical performance, as well as sleep and quality of life, will be administered at the baseline, fourth week and the sixth week of the study.

The trainer (i.e. research student) will provide a tutorial before the start of the study by explaining and demonstrating how the to play the game, and also supervising game playing sessions.
Intervention code [1] 293910 0
Lifestyle
Comparator / control treatment
The sham control group will play the Sims video game in a similar frequency and duration as the training group (i.e. 1 hr X 3 sessions/week X 6 weeks).
In this game, players need to perform tasks identical to real-life activities (e.g. eating, bathing, shopping), and managing relationships with other characters. The game does not demand players to navigate through the game in a pre-determine time duration or in-game objectives.
Control group
Placebo

Outcomes
Primary outcome [1] 297350 0
Processing speed, assessed by choice reaction time task.
In this task measuring processing speed, participants will be presented with a stimulus (i.e. light). The light will appear alternately in different shades of blue, red and white. The participants will be instructed to press the right button if blue light appears, left button if red light appears, and not press any button if white light appears. The primary measure of the task is the average differences between the time light appears and the time when participants press the button.
Participants may spend approximately 5 minutes to complete this task.


Timepoint [1] 297350 0
Baseline, fourth week and final week of intervention
Primary outcome [2] 297472 0
Cognitive control, assessed by n-back task, trail-making task, and Stroop task.

1. n-back task
The task aims to measure the updating process. This is a dynamic process involving coding and monitoring present stimulus and information while regulating relevant stored information in order to make sense of the task at hand (Miyake et al., 2000). In this task, participants will be presented with a stimulus, and instructed to determine if the current stimulus is identical to the previous two stimuli or not. The stimuli will continuously appear on the computer screen and participants will respond as fast as possible. The primary measure of this task is the accuracy measure and reaction times. It may take up to 10 minutes to complete.

2. Trail-making task
This task aims to measure the shifting process. Shifting process demands one to shift their attention between multiple stimuli (Miyake et al., 2000). It may require one to engage and disengage from stimuli following based on its relevancy. In this task, participants will be presented with two part of the test.
i. Part A
Participants need to draw a connecting line between 25 numbered circles in ascending order (E.g. 1-2-3-4 etc).

ii. Part B
Participants need to draw a connecting line between 25 circles labelled with numbers and letters. In this part, participants are required to draw connecting in ascending order but alternating between numbers and letters (E.g. 1-A-2-B-3-C etc).
They will be instructed to complete the tasks as soon as possible, and the primary measure is the time taken to complete the task. Participants may take up to 10 minutes for these tasks.

3. Stroop Task
This task aims to measure inhibiting process as describes by Miyake et al. (2000) as ‘a decrease in activation levels due to negative activation’. However, it is important to note that inhibition may occur spontaneously rather than a controlled, conscious process. The participants will be presented with a series of words (e.g. BLUE, YELLOW, BLACK) and they have to choose the colour of the word instead of the word itself. For example:
BLUE = (answer) RED, GREEN = (answer) BLUE
The primary measures for this test isare the number of correctcompleted trialsresponses and the number of correct responses completed in 3 minutes.
Timepoint [2] 297472 0
Baseline, fourth week and final week of intervention
Primary outcome [3] 297473 0
Reasoning, assessed by Raven’s Standard Progressive Matrices (RSPM).
This task aims to measure non-verbal reasoning ability. This test will present participants with a complex visual pattern with a piece cut out of it. Participants are instructed to find the matching piece from alternative answer available. The primary measure is the number of correct answers. Participants may take up to 20 minutes for the task.
Timepoint [3] 297473 0
Baseline, fourth week and final week of intervention
Secondary outcome [1] 320783 0
Physical fitness, assessed by 6-Minute Walk Test.
The test is designed to measure the aerobic fitness of an individual. It is developed from the 12-Minute Walk Test and has been widely used in individual with limited aerobic capacity (e.g. heart and lung disease). Participants will walk following a 30 m walking course with cones marking the turnaround point. They will be instructed to walk on a flat ground on their own pace and may stop for a while if desires. The primary measure of this test is the distance covered by the end of 6 minutes.
Timepoint [1] 320783 0
Baseline, fourth week and final week of intervention
Secondary outcome [2] 320784 0
Sleep quality, assessed by Pittsburgh Sleep Quality Index (PSQI).
PSQI is a self-administered, 19-item questionnaire developed to assess sleep quality and disturbance for the last one month. The items are designed to determine seven subjective sleep-related components which are sleep latency, sleep duration, habitual sleep efficiency, sleep disturbance, use of sleep medication, and daytime dysfunction.
It will take up to 5 minutes to complete the questionnaire.
Timepoint [2] 320784 0
Baseline, fourth week and final week of intervention
Secondary outcome [3] 320785 0
Quality of life, assessed by AQoL-8D.
This is a self-rated questionnaire, administered to gauge the health-related quality of life by rating 35 items which tap into eight different dimensions. They are independent living, mental health, coping, relationships, pain, self-worth, happiness and senses.
It will take approximately 5 minutes to complete the questionnaire.
Timepoint [3] 320785 0
Baseline, fourth week and final week of intervention
Secondary outcome [4] 321148 0
Balance, assessed by Berg’s Balance Test.
This is a validated 14-item scale aims to assess static and dynamic balance, and fall risk among older adults. Performance of each item will be rated using 5-point ordinal scale (0-4). The rating will be guided by whether participants need assistance or supervision in performing these tasks. The test will take up to 15 minutes to complete. The items are as follows:

i. Sitting unsupported
Researcher will instruct participants to sit upright without leaning their back against the chair, and have their hands on the laps. Participants will maintain this position for 2 minutes.

ii. Sitting to standing
From an unsupportive sitting position and hands on the lap, participants will be instructed to stand.

iii. Standing unsupported
Participants will then remain standing without using any support safely for 2 minutes.

iv. Standing to sitting
From standing position, participants will be requested to sit back on the chair.

v. Transfers
From sitting position, participants will be instructed to transfer to and fro from the present chair (i.e. with armrests) to another chair without armrests. They are allowed to use the armrests as support.

vi. Standing with eyes closed
Participants will be instructed to stand up and close their eyes for 10 second.

vii. Standing with feet together
Still in standing position, participants will be instructed to bring their feet together and hold the position unsupported for 1 minute.

viii. Reaching forward with outstretched arm
Following this position, participants will be asked to lift their arm to 90 degree and using the third knuckles as a reference point to mark the starting point of the ruler. Then, they will be instructed to stretch their arms forward as far as possible. The distance of reaching forward is the difference between the starting point and when they are in their most forward leaning position.

ix. Retrieving an object from floor
An item will be place on the floor and participants will be asked to bend down from standing position and pick the item up.

x. Turning to look behind
With leg slightly apart, participants will be asked to look behind their right shoulder, and then their left shoulder.

xi. Turning 360 degrees
Participants will turn to a full circle in one direction, and again to the opposite directions after a brief pause.

xii. Standing with one foot in front
Participants will stand with foot in front of the other and maintain in that position for 30 seconds.

xiii. Standing on one foot
The researcher will ask the participants to stand on one foot for 10 seconds, and switch to another foot for another ten.

xiv. Placing an alternate foot on a stool
Using a stool, participants will put alternate feet on the steps four times each for a total duration of 20 seconds.
Timepoint [4] 321148 0
Baseline, fourth week and final week of intervention
Secondary outcome [5] 321149 0
[Primary outcome]

Memory recall, assessed by cued word pair association task.
In the learning condition, participants will listen to 20 word pair list and ask to recall as many pairs as possible while the researcher presents cue for each pair. In this condition, the researcher will repeatedly provide participants with cue words until participants achieved 60% correct responses. The testing condition will take place after a 5 minute interval in which participants will be unexpectedly asked to recall the word list again. During the interval period, participants will perform verbal fluency task. This task requires participants to produce as many words as possible of a given category in 60 seconds duration. For example, they need to list out as many animals as possible during the 60 seconds duration. For the retrieval of word pair, no time limit will be imposed. Participants will be measured for the percentage of retention rate (i.e. number of correctly retrieved word at recall over number of correctly encoded words). Participants may spend up to 15 minutes, inclusive of interval time, for this take
Timepoint [5] 321149 0
Baseline, fourth week and final week of intervention

Eligibility
Key inclusion criteria
1. Male and female adults aged 60 years and over
2. Able to ambulate
3. Normal and/or corrected visual sensory
4. Non-expert console gamers, defined as playing video games less than 1 hr/week for the past 2 years (Boot, Kramer, Simons, Fabiani, & Gratton, 2008)
5. Scores 24 or higher on Mini Mental Status Examination (MMSE) (Folstein, Folstein, & McHugh, 1975)
6. Do not have risk against physical activity
7. Have less than two moderate to vigorous aerobic or resistance training sessions of more than 20 minutes per week (Moul, Goldman, & Warren, 2005), and
8. Understand written and spoken English
Minimum age
60 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Diagnosed with neurodegenerative disorders, mental health disorders and epilepsy

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)
Central randomisation will be conducted using Ms Excel using a random function.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Stratified allocation. Factors will be used for stratification are:

1. Sex - male, female
2. Fitness level which will be evaluated using 6-Minute Walk Test - good (more than 604m), average(498-604m), poor (less than 498 m)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s

The people assessing the outcomes
Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
Sample size estimation
Sample size estimation is calculated in reference to published effect size of 0.805 (Maillot et al., 2012) for cognitive outcomes from cognitive training intervention. The calculation yields a total sample of 104 (i.e. 26 per group) with the power of 0.80 and p<0.05.

Data analysis
Descriptive statistics will be used to report demographic data in frequency, mean and standard deviation. Correlation analysis will be conducted to examine the link between cognitive performance, physical fitness, sleep quality and quality of life. Multiple regression analysis will be used to determine whether changes of quality of life is predicted by cognition, sleep, and physical fitness. A two-factor, repeated measure (3 (Time) X 4 (Condition)) ANOVA will be conducted to determine whether there are any group differences in the outcome measures.

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
17/03/2016
Actual
19/10/2016
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
104
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW

Funding & Sponsors
Funding source category [1] 292884 0
Self funded/Unfunded
Name [1] 292884 0
Shuhada Mansor
Country [1] 292884 0
Australia
Primary sponsor type
University
Name
University of Sydney
Address
The University of Sydney
NSW 2006
Country
Australia
Secondary sponsor category [1] 291628 0
Individual
Name [1] 291628 0
Mark Halaki
Address [1] 291628 0
Room K 122
K Block C43
Faculty of Sciences
The University of Sydney
East St Lidcombe NSW 2141
Country [1] 291628 0
Australia
Secondary sponsor category [2] 291663 0
Individual
Name [2] 291663 0
Chin Moi Chow
Address [2] 291663 0
Room K 222
K Block C43
Faculty of Sciences
The University of Sydney
East St Lidcombe NSW 2141
Country [2] 291663 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 294384 0
Human Research Ethics Committee, The University of Sydney
Ethics committee address [1] 294384 0
Ethics committee country [1] 294384 0
Australia
Date submitted for ethics approval [1] 294384 0
11/12/2015
Approval date [1] 294384 0
02/03/2016
Ethics approval number [1] 294384 0
HREC No: 2016/030

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 63530 0
Dr Mark Halaki
Address 63530 0
Room K 122
K Block C43
The University of Sydney
NSW 2006
Country 63530 0
Australia
Phone 63530 0
+61 2 9351 9883
Fax 63530 0
+61 2 9351 9204
Email 63530 0
[email protected]
Contact person for public queries
Name 63531 0
Shuhada Mansor
Address 63531 0
Exercise and Sports Science Discipline
Room R 013
R Building
Faculty of Sciences
The University of Sydney
East St Lidcombe NSW 2141
Country 63531 0
Australia
Phone 63531 0
+61 4522 96300
Fax 63531 0
Email 63531 0
[email protected]
Contact person for scientific queries
Name 63532 0
Mark Halaki
Address 63532 0
Room K 122
K Block C43
The University of Sydney
NSW 2006
Country 63532 0
Australia
Phone 63532 0
+61 2 9351 9883
Fax 63532 0
Email 63532 0
[email protected]

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Basic resultsNo 370118-(Uploaded-16-07-2019-15-27-23)-Basic results summary.docx
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