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.
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
- Recruiting
Loughborough University
Loughborough, Leicestershire, LE11 3TU
Ahmet Begde
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 group | Role | What they receive |
|---|---|---|
| Cognitive dual task training (CDT) Group | Experimental | The 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 Group | Active comparator | The 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.
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
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)
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
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
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
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
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
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
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
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.
- First posted27 May 2022
- Study start11 Apr 2022
- Primary completion30 Sep 2023 (estimated)
- Study completion30 Sep 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Older PeopleStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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)
Sponsor and investigators
- Lead sponsor
- Loughborough University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ahmet Begde, Loughborough University
- Investigators
- Ahmet Begde, Principal investigator, Loughborough UniversityAlaa Algurafi, Principal investigator, Loughborough UniversityMatthew Pain, Study director, Loughborough UniversityGlen Blenkinsop, Study director, Loughborough UniversityEef Hogervorst, Study director, Loughborough University
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
Study at a glance
From the registry record, last updated by the sponsor on 27 May 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Cognitive Exergame Training on Dual-Task Cost and Balance Stability of the Individuals Between 65 and 85 Years
- ClinicalTrials.gov ID
- NCT05395676
- Acronym / sponsor ID
- 5832
- Conditions
- Older People
- Keywords
- Balance, cognition, exergame, dual-task, older adults
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Loughborough UniversityUniversity, hospital or other
- Study start
- 11 Apr 2022 (actual)
- Primary completion
- 30 Sep 2023 (estimated)
- Study completion
- 30 Sep 2023 (estimated)
- First posted
- 27 May 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Non-randomised controlled trial
| Arm | Type | Receives |
|---|---|---|
| Cognitive dual task training (CDT) Group | Experimental | Device: Exergame home training programmeThe 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. |
| Balance dual task (BDT) training Group | Active comparator | Device: Exergame home training programmeThe 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. |
Who may qualify
- Ages
- 65 to 85 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Exergame home training programmeEach 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). | Device | Balance dual task (BDT) training Group, Cognitive dual task training (CDT) Group |
Primary outcome
Change in Dual-task cost
Time frame: 8 weeks
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%
Change in Static balance task
Time frame: 8 weeks
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.
8 secondary outcomes
Change in Limit of stability task
Time frame: 8 weeks
Change in Arithmetic tasks
Time frame: 8 weeks
Change in Functional Reach (FR) Test
Time frame: 8 weeks
Change in Visual sensitivity test
Time frame: 8 weeks
Change in Corsi Block-Tapping Test
Time frame: 8 weeks
Change in Hopkins Verbal Learning Test
Time frame: 8 weeks
Change in Mobility (Fall Risk)
Time frame: 8 weeks
Change in Stroop Colour-Word test
Time frame: 8 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 May 2022.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ahmet Begde principal investigator
Loughborough University
Alaa Algurafi principal investigator
Loughborough University
Matthew Pain study director
Loughborough University
1 site in 1 country: see every site and its status.
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.