Mild Cognitive ImpairmentNCT04959383
Exergame Balance Training for Patients With Mild Cognitive Impairment
A study testing Low complexity Exergaming group, Moderate complexity Exergaming group and High complexity Exergaming group in people with Mild Cognitive Impairment, run by Riphah International University at 1 site in Pakistan.
Trial summary
This study will be a randomized control trial, which will be conducted on older adults with mild cognitive impairment. A specially designed Exergame balance training will be used for cognitive enhancement in patients with MCI. Read more about this study
- Who is it for?
- Ages 55 to 75 years
- Conditions the study is for
- Mild Cognitive Impairment
- What is being tested?
- Low complexity Exergaming group, Moderate complexity Exergaming group and High complexity Exergaming group
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 90 participants
- Where
- 1 sitePakistan
- Study dates
- 23 Sep 2021to 30 Dec 2022
- 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 55 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age ≥ 55
- MoCA =20-24
- CDR ( dementia rating scale)≤ 1.0
- No unstable disease precluding planned exercise.
- Able to see and hear sufficiently to participate in planned physical and computer-based cognitive training.
- Patients score >45 on Berg Balance Scale.
Who cannot join
- Participation in any cognitive training activity
- Participation in > 150 min/wk of moderate or greater intensity planned exercise of any kind.
- Non-ambulatory or major mobility disorder.
- Other neurological conditions associated with cognitive impairment such as stroke, Parkinson disease, and head injury
- Any clinically significant psychiatric condition, current drug or alcohol abuse, or laboratory abnormality that would interfere with the ability to participate in the study.
- Individual with any musculoskeletal impairment.
- Unwillingness to participate.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Exergame Balance Training for Pre Frontal Brain Activity and Executive Functioning in Patients With Mild Cognitive Impairment
This study will be a randomized control trial, which will be conducted on older adults with mild cognitive impairment. A specially designed Exergame balance training will be used for cognitive enhancement in patients with MCI. This training will determine the improvement in executive functioning, balance, speech and electrical activity of the brain.
Read the detailed description
From last few years the line of research for cognitive enhancement has been shifted towards balance training as balance training is considered to directly stimulate the neuronal activity as compare to aerobic training. The previous finding also proposed that in aerobic training it is the intensity of training that improves the neuroplasticity and cognition but it is the neuro-cognitive demands and complexity of the task in balance training that affects the relationship between exercise and cognition in balance training. There is a need to determine the effect of the level of complexity of balance training on neural activity and executive functioning. Exergame augmented balance training is expected to have a better physical and cognitive outcome as compared to traditional balance training.
- Conditions
- Mild Cognitive Impairment
- Being tested
- Low complexity Exergaming group, Moderate complexity Exergaming group, High complexity Exergaming group, Control Group
- Keywords
- Brain Activity, Executive Functions, Exergame balance training, Mild Cognitive Impairment
- Medical subject headings
- Cognitive Dysfunction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Low complexity Exergaming groupOther
Also called Group A
This group will receive 30 minutes of Exergame Balance Training on Modified wobble board 3 times a week for 8 weeks. Wobble board will be able to rock in all direction with Weight Transfer. Wobble board based exergame balance training group game complexity will be kept low for this group.
Moderate complexity Exergaming groupOther
Also called Group B
This group will receive 30 minutes of Exergame Balance Training on Modified wobble board 3 times a week for 8 weeks. Wobble board will be able to rock in all direction with Weight Transfer. Wobble board based exergame balance training group game complexity will be kept moderate for this group.
High complexity Exergaming groupOther
Also called Group C
This group will receive 30 minutes of Exergame Balance Training on Modified wobble board 3 times a week for 8 weeks. Wobble board will be able to rock in all direction with Weight Transfer. Wobble board based exergame balance training group game complexity will be kept high for this group.
Control GroupOther
Also called Group D
This group will receive 30 minutes of Exergame Balance Training on Modified wobble board 3 times a week for 8 weeks. This group will receive exergame balance training on Wii fit. Participants in this group will play Soccer Heading, Ski Slalom, Ski Jump, Table Tilt, Tightrope Walk, Balance Bubble, Penguin Slide and Snowboard Slalom game.
| Study group | Role | What they receive |
|---|---|---|
| Low complexity Exergame balance training group | Experimental | Wobble board based exergame balance training, the game complexity will be low for this group. Receives: Other: Low complexity Exergaming group |
| Moderate complexity exergame balance training group | Experimental | Wobble board based exergame balance training, game complexity will be moderate for this group. Receives: Other: Moderate complexity Exergaming group |
| High complexity exergame balance training group | Experimental | Wobble board based exergame balance training, game complexity will be high for this group. Receives: Other: High complexity Exergaming group |
| Control group | Active comparator | Wii fit based Exergame training on a stable surface Receives: Other: Control Group |
What is being measured
The primary outcome is the main question the study is designed to answer.
Stroop test
Stroop test measure attention, processing speed, cognitive flexibility, and working memory. This test has good specificity (0.85-0.90). Coloured squares (red, green, blue) are presented in rows first (Stroop A), followed by those colour words typed in black ink (Stroop B), followed by incongruent colour words (Stroop C; in which participants will be asked to name the colour of the ink while ignoring the written word). A ratio will be computed to isolate the executive function component of the task. Assessment will be done at baseline, after the 4th and 8th week.
Measured: 8th weeks
Trails Test
Trails test is used to assess selective attention, mental flexibility, visual-spatial skills and motor speed. It requires participants to connect numbered circles in ascending order. Color trails-2, requires individuals to connect numbered circles in consecutive order while also alternating the alphabets of the circle. Reliability and validity are adequate. Higher ratios represent a better executive function. Assessment will be done at baseline, after the 4th and 8th week.
Measured: 8th weeks
Digit Span Forward and Backward
This test measures working memory's number storage capacity. It requires participants to first listen to a list of numbers and repeat them, with the string length increasing to the maximum of their ability. Digit Span Backward, requires repeating a string of numbers in reverse order. Continuing the pattern above to isolate the executive function component, the ratio of the typically smaller sum of correct interference trials on Digit Span Backward, divided by the typically greater sum of correct basic attention trials on Digit Span Forward. Assessment will be done at baseline, after the 4th and 8th week.
Measured: 8th weeks
Montreal Cognitive Assessment
The MoCA was administered at baseline to characterize the sample as either normative aging or "screened as MCI" The MoCA consists of eight different subtests to assess overall cognitive impairment. Scores below 24 out of 30 were used to categorize MCI. This scale has a good reliability with Cronbach's alpha of 0.905. Its sensitivity is 88% and specificity is 98%. Assessment will be done at baseline, after the 4th and 8th week.
Measured: 8th weeks
Alzheimer's disease Assessment Scale
Alzheimer's disease Assessment Scale will be used for Immediate and Delayed Recall Participants shows a list of 11 words on cards and they recall as many as they are able immediately and also after a delay interval. The number of errors/omissions comprises the score, so lower scores are better. It is a reliable tool with Cronbach's alpha of 0.83. Assessment will be done at baseline, after the 4th and 8th week.
Measured: 8th weeks
Time Up and Go Test
The participants rise from sitting, walk 10 feet, turn around and return to the sitting position. The time it takes to complete the task is the score. Lower scores are better. It has a very good validity of 0.857. Assessment will be done at baseline, after the 4th and 8th week.
Measured: 8th weeks
Mini Brief Balance Evaluation Systems
It is a reliable and valid tool. The mini Balance Evaluation Systems Test (BES Test) is a 14-item clinical balance assessment tool, developed to assess balance across six contexts of postural control: mechanical constraints, limits of stability, postural response to the induced loss of balance, sensory orientation, and gait. Assessment will be done at baseline, after the 4th and 8th week.
Measured: 8th weeks
Smartphone Gait and Balance Application
The system consists of the following three components: i) a smartphone that has an embedded accelerometer, ii) a belt to house the phone on the lower back, iii) and a smartphone balance application. There are six different tasks that the subject have to perform with the system, like, normal walking up to 6 meters, walking with head movement, standing with eyes open and close and standing on a compromised surface with eyes open and close. This app. will calculate mediolateral and anterior-posterior sway during each task. Assessment will be done at baseline, after the 4th and 8th week.
Measured: 8th weeks
Force Plate
Force Plate is a reliable and valid tool for balance assessment (ICC=0.8). In the force platform test, the mean velocity of the mediolateral (ML) and anterior-posterior (AP) movement of the COP will be calculated (mm/s) according to the displacement of the COP during each second. The mean moment of velocity (m m2/s) will be calculated as the mean of the areas covered by COP movement during each second of the Force Platform. Assessment will be done at baseline, after the 4th and 8th week.
Measured: 8th weeks
Gait Speed Assessment
Self-selected gait speed (SSGS), fast gait speed (FGS), Cadence are considered to be decreased in patients with MCI. Gait speed will be assessed over 6 meters, and usual- and fast-pace walking mode. The test will be repeated twice with the mean of the two trials will be used for scoring purposes. Participants will be instructed to walk from a standing start at a pace that was normal and comfortable for them or to walk as fast as they could until they reached the end of the marked path. The participants will be asked to stop when their foot contacted the floor at the end of the walking course. Assessment will be done at baseline, after the 4th and 8th week.
Measured: 8th weeks
Electroencephalography
An electroencephalography scalp electro-voltage activity (sampling frequency: 128Hz, bandpass hardware filter:1-32Hz) will be used. Delta, theta, beta1 and beta2 will be measured in eye open and closed state. Assessment will be done at baseline, after the 4th and 8th week.
Measured: 8th week
Blood Biomarkers
The blood biomarkers will be assessed. A 5-mL blood sample will be obtained from the patient. The blood samples will be withdrawn for analysis of serum. The blood samples will be centrifuged. Samples will be and stored at - 80 °C for further serum marker assays. Assessment will be done at baseline, after the 4th and 8th week. Blood biomarkers BDNF, IGF-2, VEGF, TNFα, total-tau, amyloid beta-42, a-Synuclein, IL-10, IL1 and IL4 will be measured.
Measured: 8th weeks
Secondary outcomes (1)
Voice Recording
The Voice of all the patients will be recorded. Through voice recording pause length, verbal reaction time, and amount of silence will be assessed.
Each participant performed four spoken tasks. The tasks consisted of a counting backward task, a sentence repeating task, an image description task, and a verbal fluency task. Each task will be recorded entirely to extract specific vocal features, including pause length, verbal reaction time, and amount of silence. Assessment will be done at baseline, after the 4th and 8th week.
Measured: 8th weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jul 2021
- Study start23 Sep 2021
- Primary completion30 Dec 2022
- Study completion30 Dec 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (18)Papers the sponsor has linked to this study.
- Other trials for Mild Cognitive ImpairmentStudies of the same condition, open and under way.
- More trials run by Riphah International UniversityThe sponsor's other registered studies.
- 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
- Randomised
- Intervention model
- Parallel groups
- Model description
- Assignment
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 90 participants (actual)
Sponsor and investigators
- Lead sponsor
- Riphah International University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Imran Amjad, PhD, Study chair, Riphah international university.pakistan
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04959383
- Sponsor's protocol ID
- REC/1954 Aruba Saeed
- Status last verified
- May 2023
- First submitted
- 26 Jun 2021
- Last updated
- 30 May 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Fjell AM, Walhovd KB. Structural brain changes in aging: courses, causes and cognitive consequences. Rev Neurosci. 2010;21(3):187-221. doi: 10.1515/revneuro.2010.21.3.187.
PubMed 20879692Petersen RC, Doody R, Kurz A, Mohs RC, Morris JC, Rabins PV, Ritchie K, Rossor M, Thal L, Winblad B. Current concepts in mild cognitive impairment. Arch Neurol. 2001 Dec;58(12):1985-92. doi: 10.1001/archneur.58.12.1985.
PubMed 11735772Hanninen T, Hallikainen M, Tuomainen S, Vanhanen M, Soininen H. Prevalence of mild cognitive impairment: a population-based study in elderly subjects. Acta Neurol Scand. 2002 Sep;106(3):148-54. doi: 10.1034/j.1600-0404.2002.01225.x.
PubMed 12174174Angevaren M, Aufdemkampe G, Verhaar HJ, Aleman A, Vanhees L. Physical activity and enhanced fitness to improve cognitive function in older people without known cognitive impairment. Cochrane Database Syst Rev. 2008 Apr 16;(2):CD005381. doi: 10.1002/14651858.CD005381.pub2.
PubMed 18425918Ludyga S, Gerber M, Brand S, Holsboer-Trachsler E, Puhse U. Acute effects of moderate aerobic exercise on specific aspects of executive function in different age and fitness groups: A meta-analysis. Psychophysiology. 2016 Nov;53(11):1611-1626. doi: 10.1111/psyp.12736. Epub 2016 Aug 24.
PubMed 27556572Saraulli D, Costanzi M, Mastrorilli V, Farioli-Vecchioli S. The Long Run: Neuroprotective Effects of Physical Exercise on Adult Neurogenesis from Youth to Old Age. Curr Neuropharmacol. 2017;15(4):519-533. doi: 10.2174/1570159X14666160412150223.
PubMed 27000776Christie BR, Eadie BD, Kannangara TS, Robillard JM, Shin J, Titterness AK. Exercising our brains: how physical activity impacts synaptic plasticity in the dentate gyrus. Neuromolecular Med. 2008;10(2):47-58. doi: 10.1007/s12017-008-8033-2. Epub 2008 Jun 6.
PubMed 18535925Fabre C, Chamari K, Mucci P, Masse-Biron J, Prefaut C. Improvement of cognitive function by mental and/or individualized aerobic training in healthy elderly subjects. Int J Sports Med. 2002 Aug;23(6):415-21. doi: 10.1055/s-2002-33735.
PubMed 12215960Barnes DE, Santos-Modesitt W, Poelke G, Kramer AF, Castro C, Middleton LE, Yaffe K. The Mental Activity and eXercise (MAX) trial: a randomized controlled trial to enhance cognitive function in older adults. JAMA Intern Med. 2013 May 13;173(9):797-804. doi: 10.1001/jamainternmed.2013.189.
PubMed 23545598Anderson-Hanley C, Arciero PJ, Brickman AM, Nimon JP, Okuma N, Westen SC, Merz ME, Pence BD, Woods JA, Kramer AF, Zimmerman EA. Exergaming and older adult cognition: a cluster randomized clinical trial. Am J Prev Med. 2012 Feb;42(2):109-19. doi: 10.1016/j.amepre.2011.10.016.
PubMed 22261206Hosseini SM, Kramer JH, Kesler SR. Neural correlates of cognitive intervention in persons at risk of developing Alzheimer's disease. Front Aging Neurosci. 2014 Aug 26;6:231. doi: 10.3389/fnagi.2014.00231. eCollection 2014.
PubMed 25206335Shubert TE, McCulloch K, Hartman M, Giuliani CA. The effect of an exercise-based balance intervention on physical and cognitive performance for older adults: a pilot study. J Geriatr Phys Ther. 2010 Oct-Dec;33(4):157-64.
PubMed 21717919Ries JD, Hutson J, Maralit LA, Brown MB. Group Balance Training Specifically Designed for Individuals With Alzheimer Disease: Impact on Berg Balance Scale, Timed Up and Go, Gait Speed, and Mini-Mental Status Examination. J Geriatr Phys Ther. 2015 Oct-Dec;38(4):183-93. doi: 10.1519/JPT.0000000000000030.
PubMed 25621384Rogge AK, Roder B, Zech A, Nagel V, Hollander K, Braumann KM, Hotting K. Balance training improves memory and spatial cognition in healthy adults. Sci Rep. 2017 Jul 18;7(1):5661. doi: 10.1038/s41598-017-06071-9.
PubMed 28720898Greblo Jurakic Z, Krizanic V, Sarabon N, Markovic G. Effects of feedback-based balance and core resistance training vs. Pilates training on cognitive functions in older women with mild cognitive impairment: a pilot randomized controlled trial. Aging Clin Exp Res. 2017 Dec;29(6):1295-1298. doi: 10.1007/s40520-017-0740-9. Epub 2017 Mar 1.
PubMed 28251569
Study at a glance
From the registry record, last updated by the sponsor on 30 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Exergame Balance Training for Pre Frontal Brain Activity and Executive Functioning in Patients With Mild Cognitive Impairment
- ClinicalTrials.gov ID
- NCT04959383
- Acronym / sponsor ID
- REC/1954 Aruba Saeed
- Conditions
- Mild Cognitive Impairment
- Keywords
- Brain Activity, Executive Functions, Exergame balance training, Mild Cognitive Impairment
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 90 participants (actual)
- Lead sponsor
- Riphah International UniversityUniversity, hospital or other
- Study start
- 23 Sep 2021 (actual)
- Primary completion
- 30 Dec 2022 (actual)
- Study completion
- 30 Dec 2022 (actual)
- First posted
- 13 Jul 2021 (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.
This study will be a randomized control trial, which will be conducted on older adults with mild cognitive impairment. A specially designed Exergame balance training will be used for cognitive enhancement in patients with MCI. This training will determine the improvement in executive functioning, balance, speech and electrical activity of the brain.
Detailed description
From last few years the line of research for cognitive enhancement has been shifted towards balance training as balance training is considered to directly stimulate the neuronal activity as compare to aerobic training. The previous finding also proposed that in aerobic training it is the intensity of training that improves the neuroplasticity and cognition but it is the neuro-cognitive demands and complexity of the task in balance training that affects the relationship between exercise and cognition in balance training. There is a need to determine the effect of the level of complexity of balance training on neural activity and executive functioning. Exergame augmented balance training is expected to have a better physical and cognitive outcome as compared to traditional balance training.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 4
- Model description
- Assignment
| Arm | Type | Receives |
|---|---|---|
| Low complexity Exergame balance training group | Experimental | Other: Low complexity Exergaming groupWobble board based exergame balance training, the game complexity will be low for this group. |
| Moderate complexity exergame balance training group | Experimental | Other: Moderate complexity Exergaming groupWobble board based exergame balance training, game complexity will be moderate for this group. |
| High complexity exergame balance training group | Experimental | Other: High complexity Exergaming groupWobble board based exergame balance training, game complexity will be high for this group. |
| Control group | Active comparator | Other: Control GroupWii fit based Exergame training on a stable surface |
Who may qualify
- Ages
- 55 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Age ≥ 55
- MoCA =20-24
- CDR ( dementia rating scale)≤ 1.0
- No unstable disease precluding planned exercise.
- Able to see and hear sufficiently to participate in planned physical and computer-based cognitive training.
Key exclusion criteria (7 listed)
- Participation in any cognitive training activity
- Participation in > 150 min/wk of moderate or greater intensity planned exercise of any kind.
- Non-ambulatory or major mobility disorder.
- Other neurological conditions associated with cognitive impairment such as stroke, Parkinson disease, and head injury
- Any clinically significant psychiatric condition, current drug or alcohol abuse, or laboratory abnormality that would interfere with the ability to participate in the study.
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 |
|---|---|---|
| Low complexity Exergaming groupAlso: Group AThis group will receive 30 minutes of Exergame Balance Training on Modified wobble board 3 times a week for 8 weeks. Wobble board will be able to rock in all direction with Weight Transfer. Wobble board based exergame balance training group game complexity will be kept low for this group. | Other | Low complexity Exergame balance training group |
| Moderate complexity Exergaming groupAlso: Group BThis group will receive 30 minutes of Exergame Balance Training on Modified wobble board 3 times a week for 8 weeks. Wobble board will be able to rock in all direction with Weight Transfer. Wobble board based exergame balance training group game complexity will be kept moderate for this group. | Other | Moderate complexity exergame balance training group |
| High complexity Exergaming groupAlso: Group CThis group will receive 30 minutes of Exergame Balance Training on Modified wobble board 3 times a week for 8 weeks. Wobble board will be able to rock in all direction with Weight Transfer. Wobble board based exergame balance training group game complexity will be kept high for this group. | Other | High complexity exergame balance training group |
| Control GroupAlso: Group DThis group will receive 30 minutes of Exergame Balance Training on Modified wobble board 3 times a week for 8 weeks. This group will receive exergame balance training on Wii fit. Participants in this group will play Soccer Heading, Ski Slalom, Ski Jump, Table Tilt, Tightrope Walk, Balance Bubble, Penguin Slide and Snowboard Slalom game. | Other | Control group |
Primary outcome
Stroop test
Time frame: 8th weeks
Stroop test measure attention, processing speed, cognitive flexibility, and working memory. This test has good specificity (0.85-0.90). Coloured squares (red, green, blue) are presented in rows first (Stroop A), followed by those colour words typed in black ink (Stroop B), followed by incongruent colour words (Stroop C; in which participants will be asked to name the colour of the ink while ignoring the written word). A ratio will be computed to isolate the executive function component of the task. Assessment will be done at baseline, after the 4th and 8th week.
Trails Test
Time frame: 8th weeks
Trails test is used to assess selective attention, mental flexibility, visual-spatial skills and motor speed. It requires participants to connect numbered circles in ascending order. Color trails-2, requires individuals to connect numbered circles in consecutive order while also alternating the alphabets of the circle. Reliability and validity are adequate. Higher ratios represent a better executive function. Assessment will be done at baseline, after the 4th and 8th week.
Digit Span Forward and Backward
Time frame: 8th weeks
This test measures working memory's number storage capacity. It requires participants to first listen to a list of numbers and repeat them, with the string length increasing to the maximum of their ability. Digit Span Backward, requires repeating a string of numbers in reverse order. Continuing the pattern above to isolate the executive function component, the ratio of the typically smaller sum of correct interference trials on Digit Span Backward, divided by the typically greater sum of correct basic attention trials on Digit Span Forward. Assessment will be done at baseline, after the 4th and 8th week.
Montreal Cognitive Assessment
Time frame: 8th weeks
The MoCA was administered at baseline to characterize the sample as either normative aging or "screened as MCI" The MoCA consists of eight different subtests to assess overall cognitive impairment. Scores below 24 out of 30 were used to categorize MCI. This scale has a good reliability with Cronbach's alpha of 0.905. Its sensitivity is 88% and specificity is 98%. Assessment will be done at baseline, after the 4th and 8th week.
Alzheimer's disease Assessment Scale
Time frame: 8th weeks
Alzheimer's disease Assessment Scale will be used for Immediate and Delayed Recall Participants shows a list of 11 words on cards and they recall as many as they are able immediately and also after a delay interval. The number of errors/omissions comprises the score, so lower scores are better. It is a reliable tool with Cronbach's alpha of 0.83. Assessment will be done at baseline, after the 4th and 8th week.
Time Up and Go Test
Time frame: 8th weeks
The participants rise from sitting, walk 10 feet, turn around and return to the sitting position. The time it takes to complete the task is the score. Lower scores are better. It has a very good validity of 0.857. Assessment will be done at baseline, after the 4th and 8th week.
Mini Brief Balance Evaluation Systems
Time frame: 8th weeks
It is a reliable and valid tool. The mini Balance Evaluation Systems Test (BES Test) is a 14-item clinical balance assessment tool, developed to assess balance across six contexts of postural control: mechanical constraints, limits of stability, postural response to the induced loss of balance, sensory orientation, and gait. Assessment will be done at baseline, after the 4th and 8th week.
Smartphone Gait and Balance Application
Time frame: 8th weeks
The system consists of the following three components: i) a smartphone that has an embedded accelerometer, ii) a belt to house the phone on the lower back, iii) and a smartphone balance application. There are six different tasks that the subject have to perform with the system, like, normal walking up to 6 meters, walking with head movement, standing with eyes open and close and standing on a compromised surface with eyes open and close. This app. will calculate mediolateral and anterior-posterior sway during each task. Assessment will be done at baseline, after the 4th and 8th week.
Force Plate
Time frame: 8th weeks
Force Plate is a reliable and valid tool for balance assessment (ICC=0.8). In the force platform test, the mean velocity of the mediolateral (ML) and anterior-posterior (AP) movement of the COP will be calculated (mm/s) according to the displacement of the COP during each second. The mean moment of velocity (m m2/s) will be calculated as the mean of the areas covered by COP movement during each second of the Force Platform. Assessment will be done at baseline, after the 4th and 8th week.
Gait Speed Assessment
Time frame: 8th weeks
Self-selected gait speed (SSGS), fast gait speed (FGS), Cadence are considered to be decreased in patients with MCI. Gait speed will be assessed over 6 meters, and usual- and fast-pace walking mode. The test will be repeated twice with the mean of the two trials will be used for scoring purposes. Participants will be instructed to walk from a standing start at a pace that was normal and comfortable for them or to walk as fast as they could until they reached the end of the marked path. The participants will be asked to stop when their foot contacted the floor at the end of the walking course. Assessment will be done at baseline, after the 4th and 8th week.
Electroencephalography
Time frame: 8th week
An electroencephalography scalp electro-voltage activity (sampling frequency: 128Hz, bandpass hardware filter:1-32Hz) will be used. Delta, theta, beta1 and beta2 will be measured in eye open and closed state. Assessment will be done at baseline, after the 4th and 8th week.
Blood Biomarkers
Time frame: 8th weeks
The blood biomarkers will be assessed. A 5-mL blood sample will be obtained from the patient. The blood samples will be withdrawn for analysis of serum. The blood samples will be centrifuged. Samples will be and stored at - 80 °C for further serum marker assays. Assessment will be done at baseline, after the 4th and 8th week. Blood biomarkers BDNF, IGF-2, VEGF, TNFα, total-tau, amyloid beta-42, a-Synuclein, IL-10, IL1 and IL4 will be measured.
1 secondary outcome
Voice Recording
Time frame: 8th weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 May 2023.
- Background: PubMed 20879692Fjell AM, Walhovd KB. Structural brain changes in aging: courses, causes and cognitive consequences. Rev Neurosci. 2010;21(3):187-221. doi: 10.1515/revneuro.2010.21.3.187.
- Background: PubMed 11735772Petersen RC, Doody R, Kurz A, Mohs RC, Morris JC, Rabins PV, Ritchie K, Rossor M, Thal L, Winblad B. Current concepts in mild cognitive impairment. Arch Neurol. 2001 Dec;58(12):1985-92. doi: 10.1001/archneur.58.12.1985.
- Background: PubMed 12174174Hanninen T, Hallikainen M, Tuomainen S, Vanhanen M, Soininen H. Prevalence of mild cognitive impairment: a population-based study in elderly subjects. Acta Neurol Scand. 2002 Sep;106(3):148-54. doi: 10.1034/j.1600-0404.2002.01225.x.
- Background: PubMed 18425918Angevaren M, Aufdemkampe G, Verhaar HJ, Aleman A, Vanhees L. Physical activity and enhanced fitness to improve cognitive function in older people without known cognitive impairment. Cochrane Database Syst Rev. 2008 Apr 16;(2):CD005381. doi: 10.1002/14651858.CD005381.pub2.
- Background: PubMed 27556572Ludyga S, Gerber M, Brand S, Holsboer-Trachsler E, Puhse U. Acute effects of moderate aerobic exercise on specific aspects of executive function in different age and fitness groups: A meta-analysis. Psychophysiology. 2016 Nov;53(11):1611-1626. doi: 10.1111/psyp.12736. Epub 2016 Aug 24.
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- 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.
Imran Amjad, PhD study chair
Riphah international university.pakistan
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Low complexity Exergaming group, Moderate complexity Exergaming group and High complexity Exergaming group in people with Mild Cognitive Impairment, run by Riphah International University at 1 site in Pakistan.
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 6 inclusion and 7 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: finished, as of the sponsor's last update on 30 May 2023. 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 Pakistan. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Stroop test (time frame: 8th weeks). The study lists 12 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04959383, which also lists 18 linked publications.
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 30 May 2023.