Geriatric PopulationNCT06047769
Effects of Board Games on Balance in Association With Cognition in Community-Dwelling Elderly.
A study testing Board Games in people with Geriatric Population, run by Riphah International University at 1 site in Pakistan.
Trial summary
As age progress incidence of fall increases. Cognitively impaired patients have poor balance and they are more prone to falls. Balance and cognitive functions are co-related in middle-aged and community-dwelling elderly. In fact age-related cognitive decline as the brain ages it has exceptional neuroplasticity. Read more about this study
- Who is it for?
- Ages 60 years and olderHealthy volunteers can take part
- Conditions the study is for
- Geriatric Population
- What is being tested?
- Board Games
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 64 participants
- Where
- 1 sitePakistan
- Study dates
- 22 Sep 2023to 30 Jan 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 60 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Males and Female participants aged 60 years or older.
- Score of 26 or more on the Mini-Mental State Examination (MMSE)
- At least one self-reported fall within the last 2 years or (BBS) score less than 52 and more than 41.
- Subjects who are willing to commit to the time commitments required by the program.
Who cannot join
- Those who will not meet the inclusion criteria.
- Presence of any physical limitation that may limit hand movement.
- Presence of a severe walking or balance impairment For Example; (Amputation, or Fracture at that time.)
- Self-reported presence of vertigo
- Any visual disease
- Currently using psychotropic medications.
- Presence of any neurological disorder
Trial locations and contacts
1 site in 1 country.
About this study
As age progress incidence of fall increases. Cognitively impaired patients have poor balance and they are more prone to falls. Balance and cognitive functions are co-related in middle-aged and community-dwelling elderly. In fact age-related cognitive decline as the brain ages it has exceptional neuroplasticity. To maintain balance and prevent falls various cognitive processes are required. Board games can be used as tools for cognitive training as they have the means to restore and form motor skills, cognitive functioning, and logical and spatial thinking. Cognitive training using simple games might improve the elements of balance and gait, and prevent falls.
Read the detailed description
In fact age-related cognitive decline, as the brain ages, it has exceptional neuroplasticity. This can be achieved by cognitive training which consists of domain-specific task completion or exercises to promote neurogenesis in that domain. Cognitive training is an approach towards enhancing neural plasticity by focusing on and training cognitive domains for balance improvement. Board games can be used as tools for cognitive training as they have the means to restore and form motor skills, cognitive functioning, and logical and spatial thinking. A board game is a generic term for a game played by placing, moving or removing pieces on a board and that utilizes a game format in which pieces are moved in particular ways on a board marked with a pattern. As a tool, board games can improve comprehension and cognitive functioning among participants.
As per a study, computer-based cognitive training by simple games such as Road Tour, Jewel Diver, and Sweep Seeker improved visuospatial memory, speed of processing and inhibition which in turn improved balance and gait, and prevented falls in community-dwelling elderly but as per the author's access, there's lack of standardization in terms of types of cognitive training program intended to improve balance in the elderly population by using simple board games. Hence, the author established the research question of whether is this technique effective in the elderly population in terms of its effects on cognition and balance to prevent falls. This study will provide insight to the clinician on whether board games-based cognitive training improves balance and prevents fall risk in the elderly population.
- Conditions
- Geriatric Population
- Being tested
- Board Games
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Board GamesOther
Participants will receive cognitive training in board games including Ludo, Chutes \& Ladder and Chess with both single and multiplayer modes. After 1 week of training, participants will receive intervention of 1 hour per day, three days a week for 8 weeks completing a total of 1440 minutes. With this technique, we will target the cognitive process of information processing, speed and executive function of the patient.
| Study group | Role | What they receive |
|---|---|---|
| Interventional Group | Experimental | Participants will receive cognitive training in board games including Ludo, Chutes \& Ladder and Chess with both single and multiplayer modes. After 1 week of training, participants will receive intervention of 1 hour per day, three days a week for 8 weeks completing a total of 1440 minutes. With this technique, we will target the cognitive process of information processing, speed and executive function of the patient. Receives: Other: Board Games |
| Control group | No intervention | Participants will receive no intervention and will be observed for 8 weeks. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Berg Balance Scale (BBS)
A testing tool with high validity ( 0.93) and reliability (0.98) was used to measure balance in the elderly. The Berg Balance Scale (BBS) is a valid tool. The total score for the BBS is 56 and a higher score means good balance. It will be measured at baseline, 4th week and 8th week.
Measured: Baseline
Berg Balance Scale (BBS)
A testing tool with high validity ( 0.93) and reliability (0.98) was used to measure balance in the elderly. The Berg Balance Scale (BBS) is a valid tool. The total score for the BBS is 56 and a higher score means good balance. It will be measured at baseline, 4th week and 8th week.
Measured: After 4 weeks
Berg Balance Scale (BBS)
A testing tool with high validity ( 0.93) and reliability (0.98) was used to measure balance in the elderly. The Berg Balance Scale (BBS) is a valid tool. The total score for the BBS is 56 and a higher score means good balance. It will be measured at baseline, 4th week and 8th week.
Measured: After 8 weeks
Mini-Mental State Exam (MMSE)
A set of 11 questions that doctors and other healthcare professionals commonly use to check for cognitive impairment (problems with thinking, communication, understanding and memory) with reliability of (0.98) and reliability (0.77). The Mini-Mental State Exam (MMSE) is a valid tool. It will be measured at baseline, 4th week and 8th week. The total score for the MMSE is 30 and a higher score means good cognition.
Measured: Baseline
Mini-Mental State Exam (MMSE)
A set of 11 questions that doctors and other healthcare professionals commonly use to check for cognitive impairment (problems with thinking, communication, understanding and memory) with reliability of (0.98) and reliability (0.77). The Mini-Mental State Exam (MMSE) is a valid tool. It will be measured at baseline, 4th week and 8th week. The total score for the MMSE is 30 and a higher score means good cognition.
Measured: After 4 weeks
Mini-Mental State Exam (MMSE)
A set of 11 questions that doctors and other healthcare professionals commonly use to check for cognitive impairment (problems with thinking, communication, understanding and memory) with reliability of (0.98) and reliability (0.77). The Mini-Mental State Exam (MMSE) is a valid tool. It will be measured at baseline, 4th week and 8th week. The total score for the MMSE is 30 and a higher score means good cognition.
Measured: After 8 weeks
Secondary outcomes (6)
Dynamic Gait Index (DGI)
A clinical tool to assess gait, balance and fall risk with reliability of (0.98). The Dynamic Gait Index (DGI) is a valid tool. It will be measured at baseline, 4th week and 8th week. The total possible score is 24. A lower score indicates greater impairment or a higher risk of falls.
Measured: Baseline
Dynamic Gait Index (DGI)
A clinical tool to assess gait, balance and fall risk with reliability of (0.98). The Dynamic Gait Index (DGI) is a valid tool. It will be measured at baseline, 4th week and 8th week. The total possible score is 24. A lower score indicates greater impairment or a higher risk of falls.
Measured: After 4 weeks
Dynamic Gait Index (DGI)
A clinical tool to assess gait, balance and fall risk with reliability of (0.98). The Dynamic Gait Index (DGI) is a valid tool. It will be measured at baseline, 4th week and 8th week. The total possible score is 24. A lower score indicates greater impairment or a higher risk of falls.
Measured: After 8 weeks
Timed Up & Go test (TUG)
It is a quick and widely used clinical performance-based measure of lower extremity function, mobility and fall risk with a specificity of 0.70 sensitivity of 0.57(17) and reliability of (0.98). The Timed Up \& Go test (TUG) test is a valid tool. The TUG is timed. The score is the time (in seconds) it takes the person to complete the task, starting from the command "Go" and stopping when the person is seated back in the chair. Times greater than 13.5 seconds are often associated with a higher risk of falls. It will be measured at baseline, 4th week and 8th week.
Measured: Baseline
Timed Up & Go test (TUG)
It is a quick and widely used clinical performance-based measure of lower extremity function, mobility and fall risk with a specificity of 0.70 sensitivity of 0.57(17) and reliability of (0.98). The Timed Up \& Go test (TUG) test is a valid tool. The TUG is timed. The score is the time (in seconds) it takes the person to complete the task, starting from the command "Go" and stopping when the person is seated back in the chair. Times greater than 13.5 seconds are often associated with a higher risk of falls. It will be measured at baseline, 4th week and 8th week.
Measured: After 4 weeks
Timed Up & Go test (TUG)
It is a quick and widely used clinical performance-based measure of lower extremity function, mobility and fall risk with a specificity of 0.70 sensitivity of 0.57(17) and reliability of (0.98). The Timed Up \& Go test (TUG) test is a valid tool. The TUG is timed. The score is the time (in seconds) it takes the person to complete the task, starting from the command "Go" and stopping when the person is seated back in the chair. Times greater than 13.5 seconds are often associated with a higher risk of falls. It will be measured at baseline, 4th week and 8th week.
Measured: After 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Sep 2023
- Study start22 Sep 2023
- Primary completion31 Dec 2023
- Study completion30 Jan 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Geriatric PopulationStudies of the same condition, open and under way.
- More trials run by Riphah International UniversityThe sponsor's other registered studies.
- 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, Care provider, Outcomes assessor
- Enrolment
- 64 participants (actual)
Sponsor and investigators
- Lead sponsor
- Riphah International University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Imran Amjad, PhD, Principal investigator, Riphah International University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06047769
- Sponsor's protocol ID
- REC01539 Muhammad Ammar
- Status last verified
- May 2024
- First submitted
- 14 Sep 2023
- Last updated
- 21 May 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Smith-Ray RL, Hughes SL, Prohaska TR, Little DM, Jurivich DA, Hedeker D. Impact of Cognitive Training on Balance and Gait in Older Adults. J Gerontol B Psychol Sci Soc Sci. 2015 May;70(3):357-66. doi: 10.1093/geronb/gbt097. Epub 2013 Nov 5.
PubMed 24192586Smith-Ray RL, Makowski-Woidan B, Hughes SL. A randomized trial to measure the impact of a community-based cognitive training intervention on balance and gait in cognitively intact Black older adults. Health Educ Behav. 2014 Oct;41(1 Suppl):62S-9S. doi: 10.1177/1090198114537068.
PubMed 25274713Willis SL, Tennstedt SL, Marsiske M, Ball K, Elias J, Koepke KM, Morris JN, Rebok GW, Unverzagt FW, Stoddard AM, Wright E; ACTIVE Study Group. Long-term effects of cognitive training on everyday functional outcomes in older adults. JAMA. 2006 Dec 20;296(23):2805-14. doi: 10.1001/jama.296.23.2805.
PubMed 17179457Noda S, Shirotsuki K, Nakao M. The effectiveness of intervention with board games: a systematic review. Biopsychosoc Med. 2019 Oct 21;13:22. doi: 10.1186/s13030-019-0164-1. eCollection 2019.
PubMed 31641371Smith GE, Housen P, Yaffe K, Ruff R, Kennison RF, Mahncke HW, Zelinski EM. A cognitive training program based on principles of brain plasticity: results from the Improvement in Memory with Plasticity-based Adaptive Cognitive Training (IMPACT) study. J Am Geriatr Soc. 2009 Apr;57(4):594-603. doi: 10.1111/j.1532-5415.2008.02167.x. Epub 2009 Feb 9.
PubMed 19220558
Study at a glance
From the registry record, last updated by the sponsor on 21 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Board Games on Balance in Association With Cognition in Community-Dwelling Elderly.
- ClinicalTrials.gov ID
- NCT06047769
- Acronym / sponsor ID
- REC01539 Muhammad Ammar
- Conditions
- Geriatric Population
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 64 participants (actual)
- Lead sponsor
- Riphah International UniversityUniversity, hospital or other
- Study start
- 22 Sep 2023 (actual)
- Primary completion
- 31 Dec 2023 (actual)
- Study completion
- 30 Jan 2024 (actual)
- First posted
- 21 Sep 2023 (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.
As age progress incidence of fall increases. Cognitively impaired patients have poor balance and they are more prone to falls. Balance and cognitive functions are co-related in middle-aged and community-dwelling elderly. In fact age-related cognitive decline as the brain ages it has exceptional neuroplasticity. To maintain balance and prevent falls various cognitive processes are required. Board games can be used as tools for cognitive training as they have the means to restore and form motor skills, cognitive functioning, and logical and spatial thinking. Cognitive training using simple games might improve the elements of balance and gait, and prevent falls.
Detailed description
In fact age-related cognitive decline, as the brain ages, it has exceptional neuroplasticity. This can be achieved by cognitive training which consists of domain-specific task completion or exercises to promote neurogenesis in that domain. Cognitive training is an approach towards enhancing neural plasticity by focusing on and training cognitive domains for balance improvement. Board games can be used as tools for cognitive training as they have the means to restore and form motor skills, cognitive functioning, and logical and spatial thinking. A board game is a generic term for a game played by placing, moving or removing pieces on a board and that utilizes a game format in which pieces are moved in particular ways on a board marked with a pattern. As a tool, board games can improve comprehension and cognitive functioning among participants.
As per a study, computer-based cognitive training by simple games such as Road Tour, Jewel Diver, and Sweep Seeker improved visuospatial memory, speed of processing and inhibition which in turn improved balance and gait, and prevented falls in community-dwelling elderly but as per the author's access, there's lack of standardization in terms of types of cognitive training program intended to improve balance in the elderly population by using simple board games. Hence, the author established the research question of whether is this technique effective in the elderly population in terms of its effects on cognition and balance to prevent falls. This study will provide insight to the clinician on whether board games-based cognitive training improves balance and prevents fall risk in the elderly population.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Interventional Group | Experimental | Other: Board GamesParticipants will receive cognitive training in board games including Ludo, Chutes \& Ladder and Chess with both single and multiplayer modes. After 1 week of training, participants will receive intervention of 1 hour per day, three days a week for 8 weeks completing a total of 1440 minutes. With this technique, we will target the cognitive process of information processing, speed and executive function of the patient. |
| Control group | No intervention | –Participants will receive no intervention and will be observed for 8 weeks. |
Who may qualify
- Ages
- 60 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Males and Female participants aged 60 years or older.
- Score of 26 or more on the Mini-Mental State Examination (MMSE)
- At least one self-reported fall within the last 2 years or (BBS) score less than 52 and more than 41.
- Subjects who are willing to commit to the time commitments required by the program.
Key exclusion criteria (7 listed)
- Those who will not meet the inclusion criteria.
- Presence of any physical limitation that may limit hand movement.
- Presence of a severe walking or balance impairment For Example; (Amputation, or Fracture at that time.)
- Self-reported presence of vertigo
- Any visual disease
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 |
|---|---|---|
| Board GamesParticipants will receive cognitive training in board games including Ludo, Chutes \& Ladder and Chess with both single and multiplayer modes. After 1 week of training, participants will receive intervention of 1 hour per day, three days a week for 8 weeks completing a total of 1440 minutes. With this technique, we will target the cognitive process of information processing, speed and executive function of the patient. | Other | Interventional Group |
Primary outcome
Berg Balance Scale (BBS)
Time frame: Baseline
A testing tool with high validity ( 0.93) and reliability (0.98) was used to measure balance in the elderly. The Berg Balance Scale (BBS) is a valid tool. The total score for the BBS is 56 and a higher score means good balance. It will be measured at baseline, 4th week and 8th week.
Berg Balance Scale (BBS)
Time frame: After 4 weeks
A testing tool with high validity ( 0.93) and reliability (0.98) was used to measure balance in the elderly. The Berg Balance Scale (BBS) is a valid tool. The total score for the BBS is 56 and a higher score means good balance. It will be measured at baseline, 4th week and 8th week.
Berg Balance Scale (BBS)
Time frame: After 8 weeks
A testing tool with high validity ( 0.93) and reliability (0.98) was used to measure balance in the elderly. The Berg Balance Scale (BBS) is a valid tool. The total score for the BBS is 56 and a higher score means good balance. It will be measured at baseline, 4th week and 8th week.
Mini-Mental State Exam (MMSE)
Time frame: Baseline
A set of 11 questions that doctors and other healthcare professionals commonly use to check for cognitive impairment (problems with thinking, communication, understanding and memory) with reliability of (0.98) and reliability (0.77). The Mini-Mental State Exam (MMSE) is a valid tool. It will be measured at baseline, 4th week and 8th week. The total score for the MMSE is 30 and a higher score means good cognition.
Mini-Mental State Exam (MMSE)
Time frame: After 4 weeks
A set of 11 questions that doctors and other healthcare professionals commonly use to check for cognitive impairment (problems with thinking, communication, understanding and memory) with reliability of (0.98) and reliability (0.77). The Mini-Mental State Exam (MMSE) is a valid tool. It will be measured at baseline, 4th week and 8th week. The total score for the MMSE is 30 and a higher score means good cognition.
Mini-Mental State Exam (MMSE)
Time frame: After 8 weeks
A set of 11 questions that doctors and other healthcare professionals commonly use to check for cognitive impairment (problems with thinking, communication, understanding and memory) with reliability of (0.98) and reliability (0.77). The Mini-Mental State Exam (MMSE) is a valid tool. It will be measured at baseline, 4th week and 8th week. The total score for the MMSE is 30 and a higher score means good cognition.
6 secondary outcomes
Dynamic Gait Index (DGI)
Time frame: Baseline
Dynamic Gait Index (DGI)
Time frame: After 4 weeks
Dynamic Gait Index (DGI)
Time frame: After 8 weeks
Timed Up & Go test (TUG)
Time frame: Baseline
Timed Up & Go test (TUG)
Time frame: After 4 weeks
Timed Up & Go test (TUG)
Time frame: After 8 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 May 2024.
- Background: PubMed 24192586Smith-Ray RL, Hughes SL, Prohaska TR, Little DM, Jurivich DA, Hedeker D. Impact of Cognitive Training on Balance and Gait in Older Adults. J Gerontol B Psychol Sci Soc Sci. 2015 May;70(3):357-66. doi: 10.1093/geronb/gbt097. Epub 2013 Nov 5.
- Background: PubMed 25274713Smith-Ray RL, Makowski-Woidan B, Hughes SL. A randomized trial to measure the impact of a community-based cognitive training intervention on balance and gait in cognitively intact Black older adults. Health Educ Behav. 2014 Oct;41(1 Suppl):62S-9S. doi: 10.1177/1090198114537068.
- Background: PubMed 17179457Willis SL, Tennstedt SL, Marsiske M, Ball K, Elias J, Koepke KM, Morris JN, Rebok GW, Unverzagt FW, Stoddard AM, Wright E; ACTIVE Study Group. Long-term effects of cognitive training on everyday functional outcomes in older adults. JAMA. 2006 Dec 20;296(23):2805-14. doi: 10.1001/jama.296.23.2805.
- Background: PubMed 31641371Noda S, Shirotsuki K, Nakao M. The effectiveness of intervention with board games: a systematic review. Biopsychosoc Med. 2019 Oct 21;13:22. doi: 10.1186/s13030-019-0164-1. eCollection 2019.
- Background: PubMed 19220558Smith GE, Housen P, Yaffe K, Ruff R, Kennison RF, Mahncke HW, Zelinski EM. A cognitive training program based on principles of brain plasticity: results from the Improvement in Memory with Plasticity-based Adaptive Cognitive Training (IMPACT) study. J Am Geriatr Soc. 2009 Apr;57(4):594-603. doi: 10.1111/j.1532-5415.2008.02167.x. Epub 2009 Feb 9.
- Individual participant dataSharing planned: No
Related trials for Geriatric Population
RecruitingPhase 3
A Study to Investigate the Efficacy and Safety of Belumosudil Compared With Best Available Therapy in Participants Aged 12 Years or Older With Chronic Graft-versus-host Disease
Chronic Graft Versus Host Disease
RecruitingPhase 3
A Trial to See if Daridorexant Can Help Adults and Elderly People With Insomnia Sleep Better During the Night and Function Better During the Day
Insomia Disorder
Active, not recruitingPhase 3
A Phase III Control Study of the Safety and Immunogenicity of vYF in Pediatric Population
Yellow Fever Immunization
Not yet recruitingObservational study
Vascular Aging and Microcirculation: Physiological Aspects of Vascular Aging in the Elderly Population (VAMP-Aging)
Aging Problems
Recruiting
Effects of Breathing Exercises on Cognition in Older Adults
Older Adults (65 Years and Older), Cognition
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.
Imran Amjad, PhD principal investigator
Riphah International University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Board Games in people with Geriatric Population, 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 4 inclusion and 7 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: finished, as of the sponsor's last update on 21 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Berg Balance Scale (BBS) (time frame: Baseline). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06047769, which also lists 5 linked publications.
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 21 May 2024.