Exergame Balance Training for Patients With Mild Cognitive Impairment

NCT ID: NCT04959383

Last Updated: 2023-05-30

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

90 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-09-23

Study Completion Date

2022-12-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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

See the medical conditions and disease areas that this research is targeting or investigating.

Mild Cognitive Impairment

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Assignment
Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Outcome Assessors

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Low complexity Exergame balance training group

Wobble board based exergame balance training, the game complexity will be low for this group.

Group Type EXPERIMENTAL

Low complexity Exergaming group

Intervention Type OTHER

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 exergame balance training group

Wobble board based exergame balance training, game complexity will be moderate for this group.

Group Type EXPERIMENTAL

Moderate complexity Exergaming group

Intervention Type OTHER

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 exergame balance training group

Wobble board based exergame balance training, game complexity will be high for this group.

Group Type EXPERIMENTAL

High complexity Exergaming group

Intervention Type OTHER

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 group

Wii fit based Exergame training on a stable surface

Group Type ACTIVE_COMPARATOR

Control Group

Intervention Type OTHER

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.

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Low complexity Exergaming group

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.

Intervention Type OTHER

Moderate complexity Exergaming group

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.

Intervention Type OTHER

High complexity Exergaming group

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.

Intervention Type OTHER

Control Group

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.

Intervention Type OTHER

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

Group A Group B Group C Group D

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* 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.

Exclusion Criteria

* 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.
Minimum Eligible Age

55 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Riphah International University

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Imran Amjad, PhD

Role: STUDY_CHAIR

Riphah international university.pakistan

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Railway General Hospital

Rawalpindi, , Pakistan

Site Status

Countries

Review the countries where the study has at least one active or historical site.

Pakistan

References

Explore related publications, articles, or registry entries linked to this study.

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.

Reference Type BACKGROUND
PMID: 20879692 (View on PubMed)

Petersen 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.

Reference Type BACKGROUND
PMID: 11735772 (View on PubMed)

Hanninen 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.

Reference Type BACKGROUND
PMID: 12174174 (View on PubMed)

Angevaren 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.

Reference Type BACKGROUND
PMID: 18425918 (View on PubMed)

Ludyga 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.

Reference Type BACKGROUND
PMID: 27556572 (View on PubMed)

Saraulli 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.

Reference Type BACKGROUND
PMID: 27000776 (View on PubMed)

Christie 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.

Reference Type BACKGROUND
PMID: 18535925 (View on PubMed)

Fabre 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.

Reference Type BACKGROUND
PMID: 12215960 (View on PubMed)

Barnes 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.

Reference Type BACKGROUND
PMID: 23545598 (View on PubMed)

Anderson-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.

Reference Type BACKGROUND
PMID: 22261206 (View on PubMed)

Hosseini 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.

Reference Type BACKGROUND
PMID: 25206335 (View on PubMed)

Shubert 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.

Reference Type BACKGROUND
PMID: 21717919 (View on PubMed)

Ries 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.

Reference Type BACKGROUND
PMID: 25621384 (View on PubMed)

Rogge 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.

Reference Type BACKGROUND
PMID: 28720898 (View on PubMed)

Greblo 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.

Reference Type BACKGROUND
PMID: 28251569 (View on PubMed)

Eggenberger P, Wolf M, Schumann M, de Bruin ED. Exergame and Balance Training Modulate Prefrontal Brain Activity during Walking and Enhance Executive Function in Older Adults. Front Aging Neurosci. 2016 Apr 12;8:66. doi: 10.3389/fnagi.2016.00066. eCollection 2016.

Reference Type BACKGROUND
PMID: 27148041 (View on PubMed)

Schattin A, Arner R, Gennaro F, de Bruin ED. Adaptations of Prefrontal Brain Activity, Executive Functions, and Gait in Healthy Elderly Following Exergame and Balance Training: A Randomized-Controlled Study. Front Aging Neurosci. 2016 Nov 23;8:278. doi: 10.3389/fnagi.2016.00278. eCollection 2016.

Reference Type BACKGROUND
PMID: 27932975 (View on PubMed)

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

REC/1954 Aruba Saeed

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.