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Older PeopleNCT05395676

Cognitive Exergame Training on Dual-Task Cost and Balance Stability in Older Adults

A study testing Exergame home training programme in people with Older People, run by Loughborough University at 1 site in United Kingdom.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

Balance stability requires both motor and cognitive (mental) functions working together. Balance stability may decrease when performing two tasks at the same time (dual task), as cognitive and motor tasks compete for performing a higher task. Read more about this study

Who is it for?
Ages 65 to 85 yearsHealthy volunteers can take part
Conditions the study is for
Older People
What is being tested?
Exergame home training programme
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
40 participants
Where
1 siteUnited Kingdom
Study dates
11 Apr 2022to 30 Sep 2023
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 65 to 85 years
  • All sexes
  • Healthy volunteers accepted
  • Older adult

Who may be able to join

  • Individuals between 65-85 years
  • Individuals with no sign of aphasia
  • Individuals with a manual muscle test score of ≤5/5
  • Individuals who can perform a full range of movement (ROM) against gravity
  • Individuals who can stand for five minutes without the use of an assistive device

Who cannot join

  • Individuals with a neurological condition (e.g. vestibular deficit, stroke, Parkinson's disease, epilepsy or peripheral neuropathy) o Individuals with a cardiovascular or musculoskeletal disorder
  • Individuals with any lower limb injury or balance disorder within the last 12 months that has affected their physical activity
  • Individuals with cognitive impairment such as dementia
  • Individuals who score over 13 points on the Short FES-I

Trial locations and contacts

1 site in 1 country.

United Kingdom1 site, 1 recruiting
  • Loughborough University

    Loughborough, Leicestershire, LE11 3TU

    Ahmet Begde

    Recruiting

Other trials in United Kingdom

About this study

Official title: The Effect of Cognitive Exergame Training on Dual-Task Cost and Balance Stability of the Individuals Between 65 and 85 Years

Balance stability requires both motor and cognitive (mental) functions working together. Balance stability may decrease when performing two tasks at the same time (dual task), as cognitive and motor tasks compete for performing a higher task. Meanwhile, social distance and remote working become a necessity due to Covid-19. The primary aim is to evaluate the feasibility of cognitive exergame training in reducing dual-task costs and improve the balance performance among individuals between 65 and 85 years. The secondary aim is to observe the effectiveness of virtual home exercise on adherence and interactive rate of the population between 65 and 85 years.

Conditions
Older People
Being tested
Exergame home training programme
Keywords
Balance, cognition, exergame, dual-task, older adults

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Exergame home training programmeDevice

    Each training programme (Xbox or Wii Fit) is aimed at improving the following issues: improper weight shifting and reduced dual tasking. The participants will be guided in the first sessions to familiarize themselves with the exercises. Then, they will be allowed to exercise independently at home. Allowing enough practice time before collecting data helps minimize practice effects. practice effects are confounding factors that can affect the results and make it difficult to identify whether the improvement in outcome is due to the training or not. The duration of the training programme will be approximately 30 minutes. Each game will be played three times (the duration for each game is approximately one minute).

Study groups in NCT05395676
Study groupRoleWhat they receive
Cognitive dual task training (CDT) GroupExperimentalThe CDT group (n = 20) will participate in games on Xbox one consoles that require a higher cognitive demand compared to those of the BDT group. The training sessions will include five different games that require participants to stand and use their hand reach function to interact with different cognitive (i.e. dual-tasking) skills, such as working memory, problem solving, Stroop effect, planning, attention and response time.
Receives: Device: Exergame home training programme
Balance dual task (BDT) training GroupActive comparatorThe BDT group (n = 20) will participate in the conventional training programme on Wii consoles that have been used by previous studies (Barcala et al. 2013; Chao et al. 2015; Kannan et al. 2019), to improve balance performance. The training sessions will include five different games that require participants to stand and use their weight shift to control the game while maintaining balance.
Receives: Device: Exergame home training programme

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Change in Dual-task cost

    A dual-task cost (DTC) occurs when attention is divided between two tasks (e.g. cognitive and motor tasks), or a delay in one task causes attention to divert to the other. This may cause a decline in balance stability and an increase in dual-task cost. Calculation of dual-task cost A decrease in dual-task performance (i.e. dual-task cost) is represented with a negative value, whereas an improvement in dual-task performance is represented by a positive value.

    DTE(%)=((dual task - single task))/(single task )× 100% An example of the formula for measuring dual-task interference using absolute values of LOS parameters is DTE(%)=((dual-task LOS (RT) - single task LOS (RT)))/(single task LOS (RT)) × 100% An increase in response latency indicates a reduction in performance, thus the following will be used instead: DTE(%)=(-(dual task - single task))/(single task )× 100%

    Measured: 8 weeks

  2. Change in Static balance task

    The static balance is the ability to keep standing steady with eyes open and with eyes closed without losing balance or taking a step (Winter 1995). The following centre of pressure COP parameters will be computed separately for the anteroposterior (AP) and Mediolateral (ML) directions, such The COP mean velocity (MV), stander deviation (SD) and total displacement area (TD) parameters.

    Measured: 8 weeks

Secondary outcomes (8)
  1. Change in Limit of stability task

    Limit of stability (LOS) is the amount of the maximum excursion of COP that can be achieved within the supported base without losing balance or taking a step. The dependent variable for LOS is COP parameters that will be collected separately for the (AP) and (ML) directions, such as the COP mean velocity, COP path and COP range (Juras et al. 2008).

    Measured: 8 weeks

  2. Change in Arithmetic tasks

    Arithmetic cognitive tasks will be measured using the parameters of response latency and response accuracy. Response latency is defined as 'the time from stimulus onset to response onset', and response accuracy is defined as 'the number of correct responses divided by the total number of responses, expressed as a percentage. The cognitive task will only record at 80% of the correct responses or higher. This technique can help to identify if the cognitive task provides an adequate challenge for participants and minimize any learning effect.

    Measured: 8 weeks

  3. Change in Functional Reach (FR) Test

    FR will measure the maximal distance that can be reached forward beyond the arm's length, without moving the feet. A yardstick will be used to measure the forward reaching length in (cm).

    Measured: 8 weeks

  4. Change in Visual sensitivity test

    The computerized visual search and detection test requires the disengagement from one focal area of attention to locate the next target (a triangle formed from constantly moving dots). The participant is instructed to press a key as soon as they could detect a triangle on the screen. The baseline level contained 15 stimuli, which are drawn in solid green lines on a black background. In the 40 complex-level stimuli, moving random dots covering the entire screen serve as background distractors. New target triangles are initially drawn with just a few visible dots of each line, and the density of these points increased linearly with time until a keypress response is registered. The screen is redrawn every 250 ms. After each response, new targets appear with random delays of at least 500 ms. Visual search results are recorded with reaction time (in ms) and the number of true and false positives.

    Measured: 8 weeks

  5. Change in Corsi Block-Tapping Test

    The test is one of the most commonly used tests to measure the visuospatial short-term and working memory. This computerised test consists of nine cubical blocks positioned on the screen. The blocks are tapped in a specific sequence (the colour of tapped blocks change). The participant is asked to remember and tap these blocks in the same sequence. The sequences are easy at the beginning, usually involving three blocks, but they become more difficult in the later stages. The results are recorded with reaction time (in ms) and the number of true and false positives. The test takes around 5 mins.

    Measured: 8 weeks

  6. Change in Hopkins Verbal Learning Test

    Each form of the Hopkins Verbal Learning Test (HVLT) consists of a 12-item word list of four words from each of the three meaning categories. The participant is instructed to listen carefully as the assessor reads the word list and tries to memorize the words. The word list is then read to the subject at a rate of about one word every 2 seconds. The patient's free recall of the list is recorded. The same procedure is done for two more attempts. After the third learning attempt, the patient is read 24 words and asked to say "yes" after each word (12 goals) that appears on the recall list, and "no" after each word (12 distractors) that does not appear. Half of the distractors are taken from the same semantic categories as the targets (relevant distractors) and a half from other categories (unrelated distractors).

    Measured: 8 weeks

  7. Change in Mobility (Fall Risk)

    Timed up and go test (<3 min) The participant is asked to rise from a standard armchair, walk to a marker 3 m away, turn, walk back, and sit down again. The time is recorded.

    Measured: 8 weeks

  8. Change in Stroop Colour-Word test

    The test measures the sensitivity to interference and the ability to suppress an automated response (time needed to read the colour words rather than the time it takes to name the colour of the letters). The baseline level contains 15 stimuli (reading colour names printed in white on a black background), the colour-interference level (naming the font colour rather than reading the printed colour name, which is always incongruent) comprise 40 stimuli.

    Measured: 8 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted27 May 2022
  2. Study start11 Apr 2022
  3. Primary completion30 Sep 2023 (estimated)
  4. Study completion30 Sep 2023 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Non-randomised
Intervention model
Parallel groups
Model description
Non-randomised controlled trial
Masking
None (open label)
Enrolment
40 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05395676
Sponsor's protocol ID
5832
Status last verified
May 2022
First submitted
18 May 2022
Last updated
27 May 2022
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A study testing Exergame home training programme in people with Older People, run by Loughborough University at 1 site in United Kingdom.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 27 May 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Ahmet Begde (+4407391312843, a.begde@lboro.ac.uk), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change in Dual-task cost (time frame: 8 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 May 2022.

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