ElderlyNCT07110870
Binaural Beats and Cognitive Physical Dual-task Training for Enhancing Cognitive Function in Older Adults With Mild Cognitive Impairment
A study testing Cognitive Physical Dual task training and Binaural Beats and Cognitive physical dual task training in people with Elderly and Mild Cognitive Impairment, run by Foundation University Islamabad at 1 site in Pakistan.
Trial summary
Mild cognitive impairment is a typical trasnitional stage betweeen the normal aging process and the onset of dementia. Mental exercises and aerobic exercises can shield brain from cognitive decline in elderly. Read more about this study
- Who is it for?
- Ages 55 years and older
- Conditions the study is for
- Elderly, Mild Cognitive Impairment
- What is being tested?
- Cognitive Physical Dual task training and Binaural Beats and Cognitive physical dual task training
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 38 participants
- Where
- 1 sitePakistan
- Study dates
- 20 Jun 2024to 20 Dec 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 55 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age group: 55 and above older adults.
- Both male and female.
- Ability to understand simple instructions.
- Montreal Cognitive Assessment score from 19-25.
Who cannot join
- Diagnosed neurological, musculoskeletal, and psychiatric disorders.
- Participants with diagnosed hearing or vision problems.
- Participants who take ≥12 seconds to complete the TUG test
Trial locations and contacts
1 site in 1 country.
Pakistan1 site
Foundation University College of Physical Therapy
Islamabad, 44000
About this study
Mild cognitive impairment is a typical trasnitional stage betweeen the normal aging process and the onset of dementia. Mental exercises and aerobic exercises can shield brain from cognitive decline in elderly. Cognitive physical dual task training is defined as participation in an activity that requires the person to engage physically and cognitively at the same time. Another approach that can improve cognitive functiom in older adults is binaural beats that can be defined as when two different tones are played into two ears, leading to the perception of a beat at frequency equal to the difference between the two tones.Elderly participants with MCI who meet the inclusion criteria will be selected. The Subjects will be randomly allocated into two groups. One group will receive BB in combination with physical dual-task training while the other group will receive cognitive physical dual-task training only for 8 weeks.
Read the detailed description
OBJECTIVES:
The objectives of this study are:
- To compare the effects of binaural beats in addition to cognitive-physical dual-task training on working memory in older adults with mild cognitive impairment.
- To compare the effects of binaural beats in addition to congitive-physical dual-task training on attention in older adults.
- To compare the effects of binaural beats in addition to cognitive-physical dual-task training executive function in older adults.
HYPOTHESIS:
Alternate Hypothesis:
- There is statistically significant difference between the group recieving binaural beats combined with cognitive-physical dual-task on working memory capacity compared to the group recieving cognitive-physical dual-task in older adults with MCI.
- There is statistically significant difference between the group recieving binural beats combined with cognitive-physical dual-task on attention compared to the group recieving cognitive-physical dual-task in older adults with MCI.
- There is statistically significant difference between the group recieving binural beats combined with cognitive-physical dual-task on executive function compared to the group recieving cognitive-physical dual-task in older adults with MCI.
Null Hypothesis:
- There is no statistically significant difference between the group recieving binaural beats combined with cognitive-physical dual-task on working memory capacity compared to the group recieving cognitive physical dual-task in older adults with MCI.
- There is no statistically significant difference between the group recieving binural beats combined with cognitive physical dual-task on attention compared to the group recieving cognitive-physical dual-task in older adults with MCI.
- There is no statistically significant difference between the group recieving binural beats combined with cognitive physical dual-task on executive function compared to the group recieving cognitive-physical dual-task in older adults with MCI.
Research Design: Experimental study. Randomized Control Trial
Clinical setting: Multidisciplinary Lab in FUCP. Study duration: 1 year
Selection Criteria:
Inclusion Criteria
- Age 55 years and above
- Male and female both
- Ability to understand simple instructions.
- Montreal Cognitive Assessment score from 19-25.
Exclusion Criteria
- Diagnosed neurological, musculoskeletal, and psychiatric disorders.
- Participants with diagnosed hearing or vision problems.
- Participants who take 12 seconds to compelete TUG test.
Technique: Non probability Purposive Sampling
Outcome Measures:
Data will be collected on Demographics and general information. Data will be collected using MOCA, Trail making Test A and B and Digit span test.
Experimental Group (A) = This group will receive Cognitive Physical dual-task training . Their outcomes will be measured at baseline, on 4th,and at 8th week of treatment.
Expermental Group (B) =This group will recive Binural Beats with Cognitive Physical dual-task training outcomes will be measured at baseline, on 4th, and at 8th week of treatment.
Data analysis techniques:
The data will be analyzed through SPSS 21 and Data would be analyzed based on the study design chosen that is random control experimental study within the community.
A printed questionnaire will be provided to the patients after obtaining written consent and providing adequate explanation regarding the study, after which the data will be presented in the form of graphs or tables.
Significance of the study:
- While existing literature lacks conclusive evidence of the effectivenss of binaural beats in combination with cognitive- physical dual-task training in older adults with mild cognitive impairment,it is only focused on a single cognitive function rather than a wide range.
- Furthure past studies have primarily focussed on healthy young adults without any specific condition and potential benefits of binaural beats for this specific population remain largely unexplored.
- Our study addresses this critical gap in the literature and will provide scientific evidence supporting the efficacy of binural beats in combination with cognitive-physcial dual-task training in older adults with mild cognitive impairmment and their effects on a wider range of cognitive functions.
- Conditions
- Elderly, Mild Cognitive Impairment
- Being tested
- Cognitive Physical Dual task training, Binaural Beats and Cognitive physical dual task training
- Keywords
- Mid Cognitive Impairment, Elderly
- Medical subject headings
- Cognitive Dysfunction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cognitive Physical Dual task trainingProcedure or surgery
Randomized Control Group (A)/ Cognitive Physical Dual Task Training Participants in control group will perform cognitive physical dual task training to improve working memory, attention and executive function in elderly with mild cognitive impairment. Dual-task training involved eight programs consist from simple dual-task to more complex dual-task tasks.
Cognitive task involves verbal fluency, attention, Forward digit span task, backward digit span task, calculation tasks and memory, aerobic exercise including performing actions like dragging the foot and placing it on floor markers (Marked from 1 to 5), Drawing any letters with their feet while seated, range of motion exercise while standing, forward walking, backward walking, tandem walking and stair climbing and strengthening exercise consisting of Thera-band with low intensity training by arms and by legs and passing/throwing a ball (0.1kg, 0.4kg) will be used for physical tasks. Eight programs will be repeated thrice, resultin
Binaural Beats and Cognitive physical dual task trainingProcedure or surgery
In experimental group, Binaural beats will be given 03 min before performing a dual task.
Participants will be in a quiet room and two tones of different frequencies will be generated through the Audacity Program (Version 3.4.2) via stereo headphones presenting a different tone to each ear.
Phase-I: A warm-up at the beginning of each session (05 min) with supervised walking exercises on a flat surface.
Phase II: Binaural beats will be induced thrice a week, for 08 weeks. Alpha, and gamma waves, over 30 min, split into two sub-sessions lasting 12 min each. Participants will be allowed to take a 6-minute rest between sub-sessions. Alpha BB (10 Hz), (R: 410 Hz, L: 400 Hz) and gamma BB (30 Hz) (R: 430 Hz, L: 400 Hz) will be provided.
Phase-III: Return to calm (05 min) with relaxation and breathing exercises, lying on the floor.
The stimulus volume, played through stereo headphones will be set by the participants at the start of the session to a comfortably loud level.
| Study group | Role | What they receive |
|---|---|---|
| Binaural Beats with Cognitive Physical Dual task training group | Experimental | It includes participants receiving Binural beats with cognitive-physical dual task training for 08 weeks treatment. Receives: Procedure: Binaural Beats and Cognitive physical dual task training |
| Cognitive Physical dual task training group | Experimental | This group involves participants receiving cognitive physical dual task training for a period of 08 weeks. Receives: Procedure: Cognitive Physical Dual task training |
What is being measured
The primary outcome is the main question the study is designed to answer.
Working Memory
The Digit Span test is one of the most commonly used measures of immediate working memory. The testing procedure for the Digit Span task will be done according to the standard administration, that is, strings of digits are read to subjects at a rate of 1 per second and the subject is asked to repeat them orally in the correct sequence (either forward or backward). The test is discontinued if the subject fails two consecutive trials. The total score corresponds to the maximum number of digits the subject can repeat correctly.
Measured: 8 weeks
Attention
Montreal cognitive assessment will be used. MoCA is a brief 30-question test that takes around 10-12 minutes to complete. A normal score is regarded to be 26 or higher. A score of 18 to 25 is an indicator of mild cognitive impairment (MCI).
Measured: 8 weeks
Executive function
Trail Making Test (TMT) A and B is a test that measures executive function. TMT is broken into two parts: TMT-A (WM) and TMT-B (EF). Each of the two parts consists of 25 circles scattered across a sheet of paper. Part A contains circles numbered from 1-25, and the individual should connect the numbers by drawing lines in ascending order. Part B contains circles with both numbers (1-13) and letters (A-L); the individual must draw lines to connect the circles in ascending order, with the added challenge of alternating between the numbers and letters (for example, 1-A-2-B-3-C, etc.). Individuals must be encouraged to connect the circles as rapid
Measured: 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Aug 2025
- Study start20 Jun 2024
- Primary completion15 Nov 2024
- Study completion20 Dec 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ElderlyStudies of the same condition, open and under way.
- More trials run by Foundation University IslamabadThe 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
- None (open label)
- Enrolment
- 38 participants (actual)
Sponsor and investigators
- Lead sponsor
- Foundation University Islamabad
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07110870
- Sponsor's protocol ID
- FUI/CTR/2024/46
- Status last verified
- Aug 2025
- First submitted
- 29 Apr 2025
- Last updated
- 8 Aug 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Binaural Beats and Cognitive Physical Dual-task Training for Enhancing Cognitive Function in Older Adults With Mild Cognitive Impairment
- ClinicalTrials.gov ID
- NCT07110870
- Acronym / sponsor ID
- FUI/CTR/2024/46
- Conditions
- Elderly, Mild Cognitive Impairment
- Keywords
- Mid Cognitive Impairment, Elderly
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 38 participants (actual)
- Lead sponsor
- Foundation University IslamabadUniversity, hospital or other
- Study start
- 20 Jun 2024 (actual)
- Primary completion
- 15 Nov 2024 (actual)
- Study completion
- 20 Dec 2024 (actual)
- First posted
- 8 Aug 2025 (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.
Mild cognitive impairment is a typical trasnitional stage betweeen the normal aging process and the onset of dementia. Mental exercises and aerobic exercises can shield brain from cognitive decline in elderly. Cognitive physical dual task training is defined as participation in an activity that requires the person to engage physically and cognitively at the same time. Another approach that can improve cognitive functiom in older adults is binaural beats that can be defined as when two different tones are played into two ears, leading to the perception of a beat at frequency equal to the difference between the two tones.Elderly participants with MCI who meet the inclusion criteria will be selected. The Subjects will be randomly allocated into two groups. One group will receive BB in combination with physical dual-task training while the other group will receive cognitive physical dual-task training only for 8 weeks.
Detailed description
OBJECTIVES:
The objectives of this study are:
- To compare the effects of binaural beats in addition to cognitive-physical dual-task training on working memory in older adults with mild cognitive impairment.
- To compare the effects of binaural beats in addition to congitive-physical dual-task training on attention in older adults.
- To compare the effects of binaural beats in addition to cognitive-physical dual-task training executive function in older adults.
HYPOTHESIS:
Alternate Hypothesis:
- There is statistically significant difference between the group recieving binaural beats combined with cognitive-physical dual-task on working memory capacity compared to the group recieving cognitive-physical dual-task in older adults with MCI.
- There is statistically significant difference between the group recieving binural beats combined with cognitive-physical dual-task on attention compared to the group recieving cognitive-physical dual-task in older adults with MCI.
- There is statistically significant difference between the group recieving binural beats combined with cognitive-physical dual-task on executive function compared to the group recieving cognitive-physical dual-task in older adults with MCI.
Null Hypothesis:
- There is no statistically significant difference between the group recieving binaural beats combined with cognitive-physical dual-task on working memory capacity compared to the group recieving cognitive physical dual-task in older adults with MCI.
- There is no statistically significant difference between the group recieving binural beats combined with cognitive physical dual-task on attention compared to the group recieving cognitive-physical dual-task in older adults with MCI.
- There is no statistically significant difference between the group recieving binural beats combined with cognitive physical dual-task on executive function compared to the group recieving cognitive-physical dual-task in older adults with MCI.
Research Design: Experimental study. Randomized Control Trial
Clinical setting: Multidisciplinary Lab in FUCP. Study duration: 1 year
Selection Criteria:
Inclusion Criteria
- Age 55 years and above
- Male and female both
- Ability to understand simple instructions.
- Montreal Cognitive Assessment score from 19-25.
Exclusion Criteria
- Diagnosed neurological, musculoskeletal, and psychiatric disorders.
- Participants with diagnosed hearing or vision problems.
- Participants who take 12 seconds to compelete TUG test.
Technique: Non probability Purposive Sampling
Outcome Measures:
Data will be collected on Demographics and general information. Data will be collected using MOCA, Trail making Test A and B and Digit span test.
Experimental Group (A) = This group will receive Cognitive Physical dual-task training . Their outcomes will be measured at baseline, on 4th,and at 8th week of treatment.
Expermental Group (B) =This group will recive Binural Beats with Cognitive Physical dual-task training outcomes will be measured at baseline, on 4th, and at 8th week of treatment.
Data analysis techniques:
The data will be analyzed through SPSS 21 and Data would be analyzed based on the study design chosen that is random control experimental study within the community.
A printed questionnaire will be provided to the patients after obtaining written consent and providing adequate explanation regarding the study, after which the data will be presented in the form of graphs or tables.
Significance of the study:
- While existing literature lacks conclusive evidence of the effectivenss of binaural beats in combination with cognitive- physical dual-task training in older adults with mild cognitive impairment,it is only focused on a single cognitive function rather than a wide range.
- Furthure past studies have primarily focussed on healthy young adults without any specific condition and potential benefits of binaural beats for this specific population remain largely unexplored.
- Our study addresses this critical gap in the literature and will provide scientific evidence supporting the efficacy of binural beats in combination with cognitive-physcial dual-task training in older adults with mild cognitive impairmment and their effects on a wider range of cognitive functions.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Binaural Beats with Cognitive Physical Dual task training group | Experimental | Procedure: Binaural Beats and Cognitive physical dual task trainingIt includes participants receiving Binural beats with cognitive-physical dual task training for 08 weeks treatment. |
| Cognitive Physical dual task training group | Experimental | Procedure: Cognitive Physical Dual task trainingThis group involves participants receiving cognitive physical dual task training for a period of 08 weeks. |
Who may qualify
- Ages
- 55 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Age group: 55 and above older adults.
- Both male and female.
- Ability to understand simple instructions.
- Montreal Cognitive Assessment score from 19-25.
Key exclusion criteria (3 listed)
- Diagnosed neurological, musculoskeletal, and psychiatric disorders.
- Participants with diagnosed hearing or vision problems.
- Participants who take ≥12 seconds to complete the TUG test
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 |
|---|---|---|
| Cognitive Physical Dual task trainingRandomized Control Group (A)/ Cognitive Physical Dual Task Training Participants in control group will perform cognitive physical dual task training to improve working memory, attention and executive function in elderly with mild cognitive impairment. Dual-task training involved eight programs consist from simple dual-task to more complex dual-task tasks. Cognitive task involves verbal fluency, attention, Forward digit span task, backward digit span task, calculation tasks and memory, aerobic exercise including performing actions like dragging the foot and placing it on floor markers (Marked from 1 to 5), Drawing any letters with their feet while seated, range of motion exercise while standing, forward walking, backward walking, tandem walking and stair climbing and strengthening exercise consisting of Thera-band with low intensity training by arms and by legs and passing/throwing a ball (0.1kg, 0.4kg) will be used for physical tasks. Eight programs will be repeated thrice, resultin | Procedure or surgery | Cognitive Physical dual task training group |
| Binaural Beats and Cognitive physical dual task trainingIn experimental group, Binaural beats will be given 03 min before performing a dual task. Participants will be in a quiet room and two tones of different frequencies will be generated through the Audacity Program (Version 3.4.2) via stereo headphones presenting a different tone to each ear. Phase-I: A warm-up at the beginning of each session (05 min) with supervised walking exercises on a flat surface. Phase II: Binaural beats will be induced thrice a week, for 08 weeks. Alpha, and gamma waves, over 30 min, split into two sub-sessions lasting 12 min each. Participants will be allowed to take a 6-minute rest between sub-sessions. Alpha BB (10 Hz), (R: 410 Hz, L: 400 Hz) and gamma BB (30 Hz) (R: 430 Hz, L: 400 Hz) will be provided. Phase-III: Return to calm (05 min) with relaxation and breathing exercises, lying on the floor. The stimulus volume, played through stereo headphones will be set by the participants at the start of the session to a comfortably loud level. | Procedure or surgery | Binaural Beats with Cognitive Physical Dual task training group |
Primary outcome
Working Memory
Time frame: 8 weeks
The Digit Span test is one of the most commonly used measures of immediate working memory. The testing procedure for the Digit Span task will be done according to the standard administration, that is, strings of digits are read to subjects at a rate of 1 per second and the subject is asked to repeat them orally in the correct sequence (either forward or backward). The test is discontinued if the subject fails two consecutive trials. The total score corresponds to the maximum number of digits the subject can repeat correctly.
Attention
Time frame: 8 weeks
Montreal cognitive assessment will be used. MoCA is a brief 30-question test that takes around 10-12 minutes to complete. A normal score is regarded to be 26 or higher. A score of 18 to 25 is an indicator of mild cognitive impairment (MCI).
Executive function
Time frame: 8 weeks
Trail Making Test (TMT) A and B is a test that measures executive function. TMT is broken into two parts: TMT-A (WM) and TMT-B (EF). Each of the two parts consists of 25 circles scattered across a sheet of paper. Part A contains circles numbered from 1-25, and the individual should connect the numbers by drawing lines in ascending order. Part B contains circles with both numbers (1-13) and letters (A-L); the individual must draw lines to connect the circles in ascending order, with the added challenge of alternating between the numbers and letters (for example, 1-A-2-B-3-C, etc.). Individuals must be encouraged to connect the circles as rapid
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 8 Aug 2025.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Cognitive Physical Dual task training and Binaural Beats and Cognitive physical dual task training in people with Elderly and Mild Cognitive Impairment, run by Foundation University Islamabad 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 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: finished, as of the sponsor's last update on 8 Aug 2025. 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?
Working Memory (time frame: 8 weeks). The study lists 3 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 8 Aug 2025.