Exer-game Balance Training on Dementia

February 23, 2023 updated by: Riphah International University

Effects of Exergame Balance Training on Dementia-Related Quality of Life and Self-Efficacy in Patients With Mild Cognitive Impairment

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

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

Study Type

Interventional

Enrollment (Actual)

40

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Pakistan
    • Punjab
      • Rawalpindi, Punjab, Pakistan
        • Railway General Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

55 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 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)
Other: 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.
Experimental: 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)
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.
Experimental: 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).
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.
Active Comparator: control group
Will receive Exer-game balance training with Wii Fit balance games
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
DEMENTIA QUALITY OF LIFE QUESTIONAIRRE (DEMQOL)
Time Frame: week 8
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
Time Frame: week 8
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)
Time Frame: week 8
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Riphah International University

Investigators

  • Principal Investigator: arshad Malik, Phd, Riphah International University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 15, 2021

Primary Completion (Actual)

August 20, 2022

Study Completion (Actual)

August 20, 2022

Study Registration Dates

First Submitted

August 27, 2021

First Submitted That Met QC Criteria

December 13, 2021

First Posted (Actual)

December 15, 2021

Study Record Updates

Last Update Posted (Actual)

February 24, 2023

Last Update Submitted That Met QC Criteria

February 23, 2023

Last Verified

February 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • REC/01032/Sehar

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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