- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06437704
Effects of Brain Training Games on Cognitive Function and Quality of Life in MCI
May 30, 2024 updated by: Riphah International University
The Effects of Brain Training Games on Cognitive Function and Quality of Life Among Older Adults With Mild Cognitive Impairment
The study aims to determine the effects of brain training games on cognitive function and Quality of life among older adults with MCI.
Study Overview
Status
Recruiting
Conditions
Intervention / Treatment
Detailed Description
The study aims to determine the effects of brain training games on cognitive function and Quality of life among older adults with MCI.This study will assess the efficacy of Brain training games.
Lumosity on the cognitive function and Quality of life among older adults with MCI .Beyond cognitive rehabilitation, this intervention holds promise as a cost-effective approach to delay, maintain, or even improve cognitive decline associated with the aging process.
Study Type
Interventional
Enrollment (Estimated)
44
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 Contact
- Name: Arshad Nawaz Malik, PhD
- Phone Number: 03334503754
- Email: arshad.nawaz@riphah.edu.pk
Study Locations
-
-
Punjab
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Islamabad, Punjab, Pakistan
- Recruiting
- Riphah International University, Gulberg Green Campus
-
Contact:
- Arshad Nawaz Malik, PhD
- Phone Number: 03334503754
- Email: arshad.nawaz@riphah.edu.pk
-
Contact:
- Lylas Ali, MS-NMPT*
- Phone Number: 03045195505
- Email: lylasali.61@gmail.com
-
Principal Investigator:
- Lylas Ali, MS-NMPT*
-
-
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
- Adult
- Older Adult
Accepts Healthy Volunteers
No
Description
Inclusion Criteria:
- Older adults of age >50 years and above
- Both male and female
- Education level matriculation at least
- Mild cognitive impairment ( MOCA score of 18-25)
- Active independent individuals with normal hearing and normal or corrected-to-normal vision.
Exclusion Criteria:
- Moderate to severe cognitive impairment
- Diagnosed case of dementia, depression or other mental issues.
- Current plans to move to another city.
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: Triple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Experimental
Brain training game (Lumosity)
|
. Group A, the experimental group will be trained using five selected games i.e.
Speed Match, Memory Matrix, Tidal treasure, Ebb and Flow and Lost in Migration from Lumosity for a period of 30 sessions , 30 min/ day over the span of 6 weeks.
|
|
Active Comparator: Control
Simulation game (Simcity buildit)
|
Group B, the active control will be trained for the same number of sessions using a simulation game, SimCity Build it, for a period of 30 sessions , 30 min/ day over the span of 6 weeks.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Montreal Cognitive Assessment Scale
Time Frame: 6 weeks
|
Brief cognitive function assessment is done using MoCA Questionnaire which consist of 12 items, that is to say visuospatial, executive functioning, short-term memory, attention or concentration, working memory, language, and lastly orientation.
The total score of this Questionnaire is 30.
As per grading system, the score of 26 to 30 represent normal cognition, score of 18 to 25 denotes mild cognitive impairment and score of 10-17 signifies moderate cognitive impairment.
Lastly, score of less than 10 embodies severe cognitive impairment.
The inter-rater reliability or ICC value is 0.96 (95% CI: 0.91-0.98).
Cronbach's alpha is 0.79 and AUC of 0.89 (95% CI: 0.83-0.95).
|
6 weeks
|
|
Trail Making Test A and B
Time Frame: 6 weeks
|
Trail making test is a brief paper and pencil test used to screen for any cognitive impairment with the test scored by how long does it takes for a person to complete it.
In part A of the test, the patient draw lines to join numbered circles from 1-to 25, connecting them in ascending order.
The average score for completing this test is 29 seconds, whereas the rule of thumb suggests a typical score of 90 seconds.
A score of greater than 78 seconds indicates deficiency.
In part B of the test, the patient connect the circles alternating between numbers from 1 to 13 and letters from A to L. The average score is 75 seconds, with score of greater than 273 seconds representing deficiency.
The rule of thumb for this test is a typical score of 3 minutes.
The retest reliability for part A is between 0.76 and 0.89 and for part B it lies between 0.86 and 0.94.
The Cronbach's alpha for this neuropsychological test is 0.90.
|
6 weeks
|
|
World Health Organization Quality of Life Brief Version (WHO-QOL BREF) Questionnaire:
Time Frame: 6 weeks
|
WHO-QOL BREIF questionnaire is a 26 items tool for measuring quality of life.
It address four domains of quality of life which includes physical health comprising of 7 items, psychological health having 6 items, social relationships 3 items, and environmental health encompassing 8 items; it also contains QOL and general health items.
Each item in the questionnaire is scored on a 5 point ordinal scale; from 1 to 5.The scores are then transformed linearly to a 0 to 100 scale where 0 score represents the worst of health and maximum score of 100 indicates best possible state of health.
The Cronbach's alpha coefficient for this questionnaire is 0.86 and the ICC value is 0.74.
The CVI score is within the range of 0.78 to 1.00
|
6 weeks
|
|
International Physical Activity Questionnaire (IPAQ);
Time Frame: 6 weeks
|
IPAQ is a self-reported tool for the assessment of level of physical activity.
It evaluates the duration of physical activity in the last 7 days in the domains of job related physical activity, transportation , house chores and house maintenance, caring for family, recreational activities, sport, and leisure-time physical activity as well as time spent sitting.
The score is recorded in the form of MET minutes.
The total minutes per week spent on each activity type, that is walking (3.3 METs), doing moderate (4.0 METs) or vigorous physical activity (8.0 METs) are calculated and converted into MET-minutes.
The sum of total MET-minutes for each activity determine the level of total physical activity.
The questionnaire has an excellent test-retest reliability for physical activity (ICC = 0.84-1.00)
as well as an exceptional concurrent validity: ρ = 0.71
|
6 weeks
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Arshad Nawaz Malik, PhD, Riphah International University Islamabad
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)
May 16, 2024
Primary Completion (Estimated)
October 16, 2024
Study Completion (Estimated)
October 16, 2024
Study Registration Dates
First Submitted
May 26, 2024
First Submitted That Met QC Criteria
May 30, 2024
First Posted (Actual)
May 31, 2024
Study Record Updates
Last Update Posted (Actual)
May 31, 2024
Last Update Submitted That Met QC Criteria
May 30, 2024
Last Verified
May 1, 2024
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- Lylas Ali
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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