Mild Cognitive ImpairmentNCT06437704
Effects of Brain Training Games on Cognitive Function and Quality of Life in MCI
A study testing Brain training game Lumosity and Simulation game simcity buildit in people with Mild Cognitive Impairment, run by Riphah International University at 1 site in Pakistan.
Trial summary
The study aims to determine the effects of brain training games on cognitive function and Quality of life among older adults with MCI. Read more about this study
- Who is it for?
- Ages 50 to 80 years
- Conditions the study is for
- Mild Cognitive Impairment
- What is being tested?
- Brain training game Lumosity and Simulation game simcity buildit
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 44 participants
- Where
- 1 sitePakistan
- Study dates
- 16 May 2024to 16 Oct 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 50 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- Moderate to severe cognitive impairment
- Diagnosed case of dementia, depression or other mental issues.
- Current plans to move to another city.
Trial locations and contacts
1 site in 1 country.
Pakistan1 site, 1 recruiting
- Recruiting
Riphah International University, Gulberg Green Campus
Islamabad, Punjab Province
Arshad Nawaz Malik, PhD, 03334503754, arshad.nawaz@riphah.edu.pk
Lylas Ali, MS-NMPT*, 03045195505, lylasali.61@gmail.com
About this study
Official title: 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.
Read the 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.
- Conditions
- Mild Cognitive Impairment
- Being tested
- Brain training game Lumosity, Simulation game simcity buildit
- Keywords
- Cognition, Aging, Quality of life, Brain training games
- Medical subject headings
- Cognitive Dysfunction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Brain training game LumosityOther
. 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.
Simulation game simcity builditOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Experimental | Experimental | Brain training game (Lumosity) Receives: Other: Brain training game Lumosity |
| Control | Active comparator | Simulation game (Simcity buildit) Receives: Other: Simulation game simcity buildit |
What is being measured
The primary outcome is the main question the study is designed to answer.
Montreal Cognitive Assessment Scale
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).
Measured: 6 weeks
Trail Making Test A and B
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.
Measured: 6 weeks
World Health Organization Quality of Life Brief Version (WHO-QOL BREF) Questionnaire:
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
Measured: 6 weeks
International Physical Activity Questionnaire (IPAQ);
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
Measured: 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 May 2024
- Study start16 May 2024
- Primary completion16 Oct 2024 (estimated)
- Study completion16 Oct 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Mild Cognitive ImpairmentStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 44 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Riphah International University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Arshad Nawaz Malik, PhD, Principal investigator, Riphah International University Islamabad
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06437704
- Sponsor's protocol ID
- Lylas Ali
- Status last verified
- May 2024
- First submitted
- 26 May 2024
- Last updated
- 31 May 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 31 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effects of Brain Training Games on Cognitive Function and Quality of Life Among Older Adults With Mild Cognitive Impairment
- ClinicalTrials.gov ID
- NCT06437704
- Acronym / sponsor ID
- Lylas Ali
- Conditions
- Mild Cognitive Impairment
- Keywords
- Cognition, Aging, Quality of life, Brain training games
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 44 participants (estimated)
- Lead sponsor
- Riphah International UniversityUniversity, hospital or other
- Study start
- 16 May 2024 (actual)
- Primary completion
- 16 Oct 2024 (estimated)
- Study completion
- 16 Oct 2024 (estimated)
- First posted
- 31 May 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The study aims to determine the effects of brain training games on cognitive function and Quality of life among older adults with MCI.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Experimental | Experimental | Other: Brain training game LumosityBrain training game (Lumosity) |
| Control | Active comparator | Other: Simulation game simcity builditSimulation game (Simcity buildit) |
Who may qualify
- Ages
- 50 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (3 listed)
- Moderate to severe cognitive impairment
- Diagnosed case of dementia, depression or other mental issues.
- Current plans to move to another city.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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. | Other | Experimental |
| Simulation game simcity builditGroup 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. | Other | Control |
Primary outcome
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).
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.
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
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
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 May 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Arshad Nawaz Malik, PhD principal investigator
Riphah International University Islamabad
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Brain training game Lumosity and Simulation game simcity buildit in people with Mild Cognitive Impairment, run by Riphah International University at 1 site in Pakistan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 31 May 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Pakistan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Arshad Nawaz Malik, PhD (03334503754, arshad.nawaz@riphah.edu.pk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Montreal Cognitive Assessment Scale (time frame: 6 weeks). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 May 2024.