Binaural Beats and Cognitive Physical Dual-task Training for Enhancing Cognitive Function in Older Adults With Mild Cognitive Impairment

NCT ID: NCT07110870

Last Updated: 2025-08-08

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 38 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-06-20
• Study Completion Date: 2024-12-20

Brief 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. 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:

1. 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.

2. To compare the effects of binaural beats in addition to congitive-physical dual-task training on attention in older adults.

3. To compare the effects of binaural beats in addition to cognitive-physical dual-task training executive function in older adults.

HYPOTHESIS:

Alternate Hypothesis:

1. 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.

2. 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.

3. 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:

1. 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.

2. 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.

3. 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

1. Age 55 years and above

2. Male and female both

3. Ability to understand simple instructions.

4. Montreal Cognitive Assessment score from 19-25.

Exclusion Criteria

1. Diagnosed neurological, musculoskeletal, and psychiatric disorders.

2. Participants with diagnosed hearing or vision problems.

3. 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:

1. 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.

2. 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.

3. 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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Binaural Beats with Cognitive Physical Dual task training group

It includes participants receiving Binural beats with cognitive-physical dual task training for 08 weeks treatment.

Group Type: EXPERIMENTAL

Binaural Beats and Cognitive physical dual task training

Intervention Type: PROCEDURE

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.

Cognitive Physical dual task training group

This group involves participants receiving cognitive physical dual task training for a period of 08 weeks.

Group Type: EXPERIMENTAL

Cognitive Physical Dual task training

Intervention Type: PROCEDURE

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

Interventions

Cognitive Physical Dual task training

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

Intervention Type: PROCEDURE

Binaural Beats and Cognitive physical dual task training

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.

Intervention Type: PROCEDURE

Eligibility Criteria

Inclusion Criteria

• Age group: 55 and above older adults.
• Both male and female.
• 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 complete the TUG test

• Minimum Eligible Age: 55 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Foundation University Islamabad

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Foundation University College of Physical Therapy

Islamabad, , Pakistan

Countries

Pakistan

Other Identifiers

FUI/CTR/2024/46

Identifier Type: -

Identifier Source: org_study_id