Exer-game Balance Training on Dementia

NCT05158595 | Completed DMC

• 1 other identifier: REC/01032/Sehar
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Mild Cognitive Impairment

Outcome Measures

Primary Outcomes (3)

• DEMENTIA QUALITY OF LIFE QUESTIONAIRRE (DEMQOL)

  it has 29 statements with five scales and each scale score is measured by taking mean of the individual items. Every item have a 5-point scale response format on enjoyment (not at all, a lot) and frequency (never, very often).

  week 8

• General Self Efficacy scale

  This tool tells human behavior and coping outcomes. It's very useful with studying behaviour of people who are living with any illness. This scale have 10-items and possible responses are "not at all ,all true"1=hardly true, 2=moderately true,3= exactly true,4=total score between 10 and 40

  week 8

• 2 Minute Walk test (2MWT)

  is a reliable and valid tool for accessing balance in older adults. Instructions given to the participants are that you have to "walk at your comfortable zone. The assessor will be half a meter behind the participant to ensure his/her safety. No encouragement or feedback is given during the whole test. Two practice trials and one final trial for record are performed. The participants are given at least 10 min rest between trials. The distance covered in the 2 min is recorded as the 2MWT

  week 8

Study Arms (4)

low intensity group

EXPERIMENTAL

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

Other: Exergaming low intensity group

moderate intensity group

EXPERIMENTAL

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

Other: Exergaming moderate intensity group

high intensity group

EXPERIMENTAL

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

Other: Exergaming high intensity group

control group

ACTIVE COMPARATOR

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

Other: control group exergaming

Interventions

Exergaming low intensity group 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.

low intensity group

Exergaming moderate intensity group 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.

moderate intensity group

Exergaming high intensity group 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.

high intensity group

control group exergaming 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.

control group

Eligibility Criteria

• Age: 55 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Riphah International University: lead

Study Sites (1)

Railway General Hospital

Rawalpindi, Punjab Province, Pakistan

Location

Related Publications (10)

• 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.

  PMID: 31993915 BACKGROUND

• 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.

  PMID: 32308666 BACKGROUND

• 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.

  PMID: 31534026 BACKGROUND

• 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.

  PMID: 30336988 BACKGROUND

• 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.

  PMID: 17851192 BACKGROUND

• 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.

  PMID: 29706986 BACKGROUND

• 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.

  PMID: 22719745 BACKGROUND

• 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.

  PMID: 30898818 BACKGROUND

• 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.

  PMID: 23207978 BACKGROUND

• 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.

  PMID: 31913961 BACKGROUND

MeSH Terms

Conditions

Cognitive Dysfunction

Condition Hierarchy (Ancestors)

Cognition Disorders; Neurocognitive Disorders; Mental Disorders

Study Officials

• Arshad Malik, PhD

  Riphah International University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 27, 2021
• First Posted: December 15, 2021
• Study Start: August 15, 2021
• Primary Completion: August 20, 2022
• Study Completion: August 20, 2022
• Last Updated: February 24, 2023

Record last verified: 2023-02

Data Sharing

• IPD Sharing: Will not share

Locations

PA (1)