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

NCT07110870 | Completed

• 1 other identifier: FUI/CTR/2024/46
• Study Type: interventional
• Target: 38
• Locations: 1 country
• Sites: 1

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.

Conditions

Elderly; Mild Cognitive Impairment

Keywords

Mid Cognitive Impairment; Elderly

Outcome Measures

Primary Outcomes (3)

• 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.

  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).

  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

  8 weeks

Study Arms (2)

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.

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.

Procedure: Cognitive Physical Dual task training

Interventions

Cognitive Physical Dual task training 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

Cognitive Physical dual task training group

Binaural Beats and Cognitive physical dual task training 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.

Binaural Beats with Cognitive Physical Dual task training group

Eligibility Criteria

• Age: 55 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age group: 55 and above older adults.
• Both male and female.
• Ability to understand simple instructions.
• Montreal Cognitive Assessment score from 19-25.

You may not qualify if:

• Diagnosed neurological, musculoskeletal, and psychiatric disorders.
• Participants with diagnosed hearing or vision problems.
• Participants who take ≥12 seconds to complete the TUG test

Sponsors & Collaborators

• Foundation University Islamabad: lead

Study Sites (1)

Foundation University College of Physical Therapy

Islamabad, 44000, Pakistan

Location

MeSH Terms

Conditions

Cognitive Dysfunction

Condition Hierarchy (Ancestors)

Cognition Disorders; Neurocognitive Disorders; Mental Disorders

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 29, 2025
• First Posted: August 8, 2025
• Study Start: June 20, 2024
• Primary Completion: November 15, 2024
• Study Completion: December 20, 2024
• Last Updated: August 8, 2025

Record last verified: 2025-08

Locations

PA (1)