Exer-game Balance Training on Dementia

NCT ID: NCT05158595

Last Updated: 2023-02-24

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

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-08-15

Study Completion Date

2022-08-20

Brief Summary

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

Age-related cognitive impairment is a wide phenomenon. Mild cognitive impairment is a transitional stage between Dementia and normal cognition.Mild cognitive impairment (MCI) is a syndrome that has been recognized in older adults and it has become a topic of a major focus on clinical care and research. In people with this condition, there are cognitive deficits and these have adverse effects on activities of daily living . These patients cannot recognize their impairment. Mild cognitive impairment is a risk factor for dementia.

Detailed Description

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

The clinical features of MCI are memory impairment along with language or speech impairments, executive functions, and visuospatial impairments. In regard to clinical features of Mild cognitive impairment (MCI), there are motor problems as patients have difficulty in doing complex motor tasks like doing pegboard assembly and also in fine and gross motor skills performance like they have difficulty in maintaining balance and body weight. Major factors contributing to mild cognitive impairment or major causes are medical conditions like hepatic or renal failure, depression, sleep disturbances, psychological problems,s and medicine side effects. impaired attention and concentration can lead to impaired memory and a decline in cognitive function.

As literature supports the evidence of the effectiveness of Exergaming in adults with neurocognitive disorders.As Exer-gaming training program improved their lower extremity functioning, cognitive function, and reduced depression, neuropsychiatric symptoms too. Recent studies on the treatment of Exergaming and its effect on the quality of life in dementia approach the standing balance Exer-gaming being effective and has increased attention, concentration, memory, and reaction time and has improved physical, cognitive, emotional, social function and quality of life and decreased the level of frailty in dementia patients. Recent literature on Exergaming has successfully improved cognition, balance,gait, and verbal memory in MCI patients and reduced fall risk in older adults of age \>55 years

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

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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

low intensity group

Will receive wobble board based Exergame balance training, game intensity will be low for this group (Size of goal will be kept large)

Group Type EXPERIMENTAL

Exergaming low intensity group

Intervention Type OTHER

wobble board-based Exergame balance training, the game intensity will be low for this group (Size of goal will be kept small for 3 times a week, 30 minutes per day for 8 weeks.

moderate intensity group

Will receive wobble board based Exergame balance training, game intensity will be low for this group (Size of goal will be kept large)

Group Type EXPERIMENTAL

Exergaming moderate intensity group

Intervention Type OTHER

Wobble board-based Exer- game balance training, the game intensity will be moderate for this group (size of goal will be kept medium).for 3 times a week, 30 minutes per day for 8 weeks.

high intensity group

Will receive wobble board-based Exergame balance training, game intensity will be high for this group (Size of goal will be kept small).

Group Type EXPERIMENTAL

Exergaming high intensity group

Intervention Type OTHER

Wobble board-based Exer- game balance training, the game intensity will be moderate for this group (size of goal will be kept high).for 3 times a week, 30 minutes per day for 8 weeks.

control group

Will receive Exer-game balance training with Wii Fit balance games

Group Type ACTIVE_COMPARATOR

control group exergaming

Intervention Type OTHER

Exer games training with soccer heading and penguin slide games(Wii Fitt balance games) for 3 times a week, 30 minutes per day for 8 weeks.

Interventions

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

Exergaming low intensity group

wobble board-based Exergame balance training, the game intensity will be low for this group (Size of goal will be kept small for 3 times a week, 30 minutes per day for 8 weeks.

Intervention Type OTHER

Exergaming moderate intensity group

Wobble board-based Exer- game balance training, the game intensity will be moderate for this group (size of goal will be kept medium).for 3 times a week, 30 minutes per day for 8 weeks.

Intervention Type OTHER

Exergaming high intensity group

Wobble board-based Exer- game balance training, the game intensity will be moderate for this group (size of goal will be kept high).for 3 times a week, 30 minutes per day for 8 weeks.

Intervention Type OTHER

control group exergaming

Exer games training with soccer heading and penguin slide games(Wii Fitt balance games) for 3 times a week, 30 minutes per day for 8 weeks.

Intervention Type OTHER

Eligibility Criteria

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

Inclusion Criteria

* Individuals \>55 years of age.
* Patients meeting mild cognitive impairment (MCI), The Montreal Cognitive Assessment (MoCA) 20-24.
* clinical dementia rating scale (CDR) ≤ 1.0
* No unstable disease precluding the planned exercise
* Able to see and hear sufficiently to participate in planned physical and computer-based cognitive training

Exclusion Criteria

* 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, that would interfere with the ability to participate in the study
* Severe visual impairment
* Unwillingness to participate
Minimum Eligible Age

55 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.

Arshad Malik, PhD

Role: PRINCIPAL_INVESTIGATOR

Riphah International University

Locations

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

Railway General Hospital

Rawalpindi, Punjab Province, 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.

Hussenoeder FS, Conrad I, Roehr S, Fuchs A, Pentzek M, Bickel H, Moesch E, Weyerer S, Werle J, Wiese B, Mamone S, Brettschneider C, Heser K, Kleineidam L, Kaduszkiewicz H, Eisele M, Maier W, Wagner M, Scherer M, Konig HH, Riedel-Heller SG. Mild cognitive impairment and quality of life in the oldest old: a closer look. Qual Life Res. 2020 Jun;29(6):1675-1683. doi: 10.1007/s11136-020-02425-5. Epub 2020 Jan 28.

Reference Type BACKGROUND
PMID: 31993915 (View on PubMed)

Griffiths J, Thaikruea L, Wongpakaran N, Munkhetvit P. Prevalence of Mild Cognitive Impairment in Rural Thai Older People, Associated Risk Factors and their Cognitive Characteristics. Dement Geriatr Cogn Dis Extra. 2020 Mar 26;10(1):38-45. doi: 10.1159/000506279. eCollection 2020 Jan-Apr.

Reference Type BACKGROUND
PMID: 32308666 (View on PubMed)

Foster NL, Bondi MW, Das R, Foss M, Hershey LA, Koh S, Logan R, Poole C, Shega JW, Sood A, Thothala N, Wicklund M, Yu M, Bennett A, Wang D. Quality improvement in neurology: Mild cognitive impairment quality measurement set. Neurology. 2019 Oct 15;93(16):705-713. doi: 10.1212/WNL.0000000000008259. Epub 2019 Sep 18. No abstract available.

Reference Type BACKGROUND
PMID: 31534026 (View on PubMed)

Tangalos EG, Petersen RC. Mild Cognitive Impairment in Geriatrics. Clin Geriatr Med. 2018 Nov;34(4):563-589. doi: 10.1016/j.cger.2018.06.005. Epub 2018 Aug 21.

Reference Type BACKGROUND
PMID: 30336988 (View on PubMed)

Mariani E, Monastero R, Mecocci P. Mild cognitive impairment: a systematic review. J Alzheimers Dis. 2007 Aug;12(1):23-35. doi: 10.3233/jad-2007-12104.

Reference Type BACKGROUND
PMID: 17851192 (View on PubMed)

Alkhunizan M, Alkhenizan A, Basudan L. Prevalence of Mild Cognitive Impairment and Dementia in Saudi Arabia: A Community-Based Study. Dement Geriatr Cogn Dis Extra. 2018 Mar 20;8(1):98-103. doi: 10.1159/000487231. eCollection 2018 Jan-Apr.

Reference Type BACKGROUND
PMID: 29706986 (View on PubMed)

Wada-Isoe K, Uemura Y, Nakashita S, Yamawaki M, Tanaka K, Yamamoto M, Shimokata H, Nakashima K. Prevalence of Dementia and Mild Cognitive Impairment in the Rural Island Town of Ama-cho, Japan. Dement Geriatr Cogn Dis Extra. 2012 Jan;2(1):190-9. doi: 10.1159/000338244. Epub 2012 Apr 24.

Reference Type BACKGROUND
PMID: 22719745 (View on PubMed)

Mohan D, Iype T, Varghese S, Usha A, Mohan M. A cross-sectional study to assess prevalence and factors associated with mild cognitive impairment among older adults in an urban area of Kerala, South India. BMJ Open. 2019 Mar 20;9(3):e025473. doi: 10.1136/bmjopen-2018-025473.

Reference Type BACKGROUND
PMID: 30898818 (View on PubMed)

Juarez-Cedillo T, Sanchez-Arenas R, Sanchez-Garcia S, Garcia-Pena C, Hsiung GY, Sepehry AA, Beattie BL, Jacova C. Prevalence of mild cognitive impairment and its subtypes in the Mexican population. Dement Geriatr Cogn Disord. 2012;34(5-6):271-81. doi: 10.1159/000345251. Epub 2012 Nov 29.

Reference Type BACKGROUND
PMID: 23207978 (View on PubMed)

Vlachos GS, Kosmidis MH, Yannakoulia M, Dardiotis E, Hadjigeorgiou G, Sakka P, Ntanasi E, Stefanis L, Scarmeas N. Prevalence of Mild Cognitive Impairment in the Elderly Population in Greece: Results From the HELIAD Study. Alzheimer Dis Assoc Disord. 2020 Apr-Jun;34(2):156-162. doi: 10.1097/WAD.0000000000000361.

Reference Type BACKGROUND
PMID: 31913961 (View on PubMed)

Other Identifiers

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

REC/01032/Sehar

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

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