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Exer-game Balance Training on Dementia

Primary Purpose

Mild Cognitive Impairment

Status
Completed
Phase
Not Applicable
Locations
Pakistan
Study Type
Interventional
Intervention
Exergaming low intensity group
Exergaming moderate intensity group
Exergaming high intensity group
control group exergaming
Sponsored by
Riphah International University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Mild Cognitive Impairment

Eligibility Criteria

55 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Railway General Hospital

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Experimental

Experimental

Active Comparator

Arm Label

low intensity group

moderate intensity group

high intensity group

control group

Arm Description

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

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

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

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

Outcomes

Primary Outcome Measures

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).
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
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

Secondary Outcome Measures

Full Information

First Posted
August 27, 2021
Last Updated
February 23, 2023
Sponsor
Riphah International University
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1. Study Identification

Unique Protocol Identification Number
NCT05158595
Brief Title
Exer-game Balance Training on Dementia
Official Title
Effects of Exergame Balance Training on Dementia-Related Quality of Life and Self-Efficacy in Patients With Mild Cognitive Impairment
Study Type
Interventional

2. Study Status

Record Verification Date
February 2023
Overall Recruitment Status
Completed
Study Start Date
August 15, 2021 (Actual)
Primary Completion Date
August 20, 2022 (Actual)
Study Completion Date
August 20, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Riphah International University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.
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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Mild Cognitive Impairment

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
40 (Actual)

8. Arms, Groups, and Interventions

Arm Title
low intensity group
Arm Type
Experimental
Arm Description
Will receive wobble board based Exergame balance training, game intensity will be low for this group (Size of goal will be kept large)
Arm Title
moderate intensity group
Arm Type
Experimental
Arm Description
Will receive wobble board based Exergame balance training, game intensity will be low for this group (Size of goal will be kept large)
Arm Title
high intensity group
Arm Type
Experimental
Arm Description
Will receive wobble board-based Exergame balance training, game intensity will be high for this group (Size of goal will be kept small).
Arm Title
control group
Arm Type
Active Comparator
Arm Description
Will receive Exer-game balance training with Wii Fit balance games
Intervention Type
Other
Intervention Name(s)
Exergaming low intensity group
Intervention Description
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
Intervention Name(s)
Exergaming moderate intensity group
Intervention Description
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
Intervention Name(s)
Exergaming high intensity group
Intervention Description
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
Intervention Name(s)
control group exergaming
Intervention Description
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.
Primary Outcome Measure Information:
Title
DEMENTIA QUALITY OF LIFE QUESTIONAIRRE (DEMQOL)
Description
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).
Time Frame
week 8
Title
General Self Efficacy scale
Description
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
Time Frame
week 8
Title
2 Minute Walk test (2MWT)
Description
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
Time Frame
week 8

10. Eligibility

Sex
All
Minimum Age & Unit of Time
55 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Arshad Malik, PhD
Organizational Affiliation
Riphah International University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Railway General Hospital
City
Rawalpindi
State/Province
Punjab
Country
Pakistan

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
31993915
Citation
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.
Results Reference
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32308666
Citation
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.
Results Reference
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PubMed Identifier
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Citation
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Results Reference
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PubMed Identifier
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Citation
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Exer-game Balance Training on Dementia

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