Cognitive Training to Improve Mobility in Middle-aged and Older Adults

NCT05418998 | Completed

• 1 other identifier: 30011799
• Study Type: interventional
• Target: 63
• Locations: 1 country
• Sites: 1

Brief Summary

The proposed study is designed to evaluate the effect of at-home executive function training on cognition and mobility in older adults with age-related hearing loss (ARHL), older adults with normal hearing, and middle-aged adults.

Conditions

Aging; Age Related Hearing Loss

Keywords

Cognitive training; Executive function; Aging; Dual-task walking; Near-infrared spectroscopy; Hearing loss; Middle age; Mobility

Outcome Measures

Primary Outcomes (10)

• Pre-training Change in auditory 2-back accuracy

  Auditory 2-back performance will be assessed under single- and dual-task conditions (i.e., while the participant is standing or simultaneously walking on a treadmill at a self-selected pace). The numbers for the task will be played through binaural speakers, and the decibel level will be individualized for each participant depending on hearing ability. Participants will be required to make a button response indicating whether the number they heard was the same or different from the number they heard two previously. Accuracy (percent correct) will be recorded. Half the participants will be given this assessment. See Outcome 5, Multi-talker, for other half.

  baseline

• Post-training Change in auditory 2-back accuracy

  Auditory 2-back performance will be assessed under single- and dual-task conditions (i.e., while the participant is standing or simultaneously walking on a treadmill at a self-selected pace). The numbers for the task will be played through binaural speakers, and the decibel level will be individualized for each participant depending on hearing ability. Participants will be required to make a button response indicating whether the number they heard was the same or different from the number they heard two previously. Accuracy (percent correct) will be recorded. Half the participants will be given this assessment. See Outcome 6, Multi-talker, for other half.

  after 12 weeks

• Pre-training Change in auditory 2-back reaction time

  Auditory 2-back performance will be assessed under single- and dual-task conditions (i.e., while the participant is standing or simultaneously walking on a treadmill at a self-selected pace). The numbers for the task will be played through binaural speakers, and the decibel level will be individualized for each participant depending on hearing ability. Participants will be required to make a button response indicating whether the number they heard was the same or different from the number they heard two previously. Reaction time (msec) will be recorded. Half the participants will be given this assessment. See Outcome 5, Multi-talker, for other half.

  baseline

• Post-training Change in auditory 2-back reaction time

  Auditory 2-back performance will be assessed under single- and dual-task conditions (i.e., while the participant is standing or simultaneously walking on a treadmill at a self-selected pace). The numbers for the task will be played through binaural speakers, and the decibel level will be individualized for each participant depending on hearing ability. Participants will be required to make a button response indicating whether the number they heard was the same or different from the number they heard two previously. Reaction time (msec) will be recorded. Half the participants will be given this assessment. See Outcome 6, Multi-talker, for other half.

  after 12 weeks

• Pre-training Multi-Talker word perception (accuracy)

  We will use the multi-talker spatial listening task for the other half of the participants, in which a presented text cue indicates which of three simultaneously presented, but spatially distributed spoken sentences to report. Traffic noise will be included to more closely simulate real- world conditions. The signal-to-noise ratio will be held constant across participants, with signal intensity set according to individual average hearing thresholds.

  baseline

• Post-training Multi-Talker word perception (accuracy)

  We will use the multi-talker spatial listening task for the other half of the participants, in which a presented text cue indicates which of three simultaneously presented, but spatially distributed spoken sentences to report. Traffic noise will be included to more closely simulate real- world conditions. The signal-to-noise ratio will be held constant across participants, with signal intensity set according to individual average hearing thresholds.

  after 12 weeks

• Pre-training Change in stride time (mean, standard deviation [SD] of stride time)

  Stride time will be assessed under single- and dual-task conditions (i.e., walking on a treadmill at a self-selected pace or while simultaneously completing the auditory 2-back task). The spatio-temporal characteristics of gait will be measured by foot pressure sensors worn on the base of the participants' shoes, with one sensor placed beneath the heel and the second sensor placed beneath the toe. The time between successive toe or heel strikes will be recorded (sec) and averaged across the trials. Those participants being assessed with Outcome 5 will perform the same walking task but in a simulated street-crossing environment.

  baseline

• Post-training Change in stride time (mean, standard deviation [SD] of stride time)

  Stride time will be assessed under single- and dual-task conditions (i.e., walking on a treadmill at a self-selected pace or while simultaneously completing the auditory 2-back task). The spatio-temporal characteristics of gait will be measured by foot pressure sensors worn on the base of the participants' shoes, with one sensor placed beneath the heel and the second sensor placed beneath the toe. The time between successive toe or heel strikes will be recorded (sec) and averaged across the trials. Those participants being assessed with Outcome 6 will perform the same walking task but in a simulated street-crossing environment.

  after 12 weeks

• Pre-training Change in stride time variability (mean, standard deviation [SD] of stride time)

  Stride time variability will be assessed under single- and dual-task conditions (i.e., walking on a treadmill at a self-selected pace or while simultaneously completing the auditory 2-back task). The spatio-temporal characteristics of gait will be measured by foot pressure sensors worn on the base of the participants' shoes, with one sensor placed beneath the heel and the second sensor placed beneath the toe. The time between successive toe or heel strikes will be recorded (sec) and the standard deviation will be taken to derive a measure of stride time variability. Those participants being assessed with Outcome 5 will perform the same walking task but in a simulated street-crossing environment.

  baseline

• Post-training Change in stride time variability (mean, standard deviation [SD] of stride time)

  Stride time variability will be assessed under single- and dual-task conditions (i.e., walking on a treadmill at a self-selected pace or while simultaneously completing the auditory 2-back task). The spatio-temporal characteristics of gait will be measured by foot pressure sensors worn on the base of the participants' shoes, with one sensor placed beneath the heel and the second sensor placed beneath the toe. The time between successive toe or heel strikes will be recorded (sec) and the standard deviation will be taken to derive a measure of stride time variability. Those participants being assessed with Outcome 6 will perform the same walking task but in a simulated street-crossing environment.

  after 12 weeks

Secondary Outcomes (26)

• Pre-training Montreal Cognitive Assessment (MoCA)

  baseline

• Post-training Montreal Cognitive Assessment (MoCA)

  after 12 weeks

• Pre-training WAIS-IV Digit Symbol Coding

  baseline

• Post-training WAIS-IV Digit Symbol Coding

  after 12 weeks

• Pre-training Trail Making Test

  baseline

Study Arms (2)

Executive function (EF) training

EXPERIMENTAL

12 weeks of at-home EF training on a computer or iPad

Behavioral: Executive function (EF) training

Wait-list control

NO INTERVENTION

This will be a comparator arm with no cognitive training. Participants will be given access to the same training program following the conclusion of the study, but no further assessment is planned.

Interventions

Executive function (EF) training BEHAVIORAL

EF training will involve at-home computer- or tablet based training to improve several EF processes, including divided attention, response inhibition, switching, and working memory updating. Training session duration = 30 min x 3 session/week.

Executive function (EF) training

Eligibility Criteria

• Age: 45 Years - 80 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Proficient in English (learned before age 5), can ambulate ≥ 10 meters independently, absence of cognitive impairment (neuropsychological test results in the average range compared to age norms), normal or corrected-to-normal visual acuity (ETDRS), availability of a home computer or tablet with internet connection.

You may not qualify if:

• Reported major depression, substance abuse or significant psychiatric disorder, uncorrected visual impairment, vestibular impairment, Parkinson's disease or other neurological disorder or sequelae, clinically significant musculoskeletal disorders, diseases affecting the ear, or damage to the ear (e.g., occupational noise), onset of hearing loss prior to adulthood.

Sponsors & Collaborators

• Concordia University, Montreal: lead
• Canadian Institutes of Health Research (CIHR): collaborator

Study Sites (1)

Concordia University

Montreal, Quebec, H3G 1M8, Canada

Location

Related Publications (1)

• Downey R, Gagne N, Mohanathas N, Campos JL, Pichora-Fuller KM, Bherer L, Lussier M, Phillips NA, Wittich W, St-Onge N, Gagne JP, Li K. At-home computerized executive-function training to improve cognition and mobility in normal-hearing adults and older hearing aid users: a multi-centre, single-blinded randomized controlled trial. BMC Neurol. 2023 Oct 20;23(1):378. doi: 10.1186/s12883-023-03405-1.

  PMID: 37864139 DERIVED

MeSH Terms

Conditions

Presbycusis; Hearing Loss

Condition Hierarchy (Ancestors)

Hearing Loss, Sensorineural; Hearing Disorders; Ear Diseases; Otorhinolaryngologic Diseases; Sensation Disorders; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Masking Details: The investigator will be blinded to group assignment.
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: May 26, 2022
• First Posted: June 15, 2022
• Study Start: August 30, 2020
• Primary Completion: August 15, 2023
• Study Completion: August 15, 2024
• Last Updated: March 14, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will share

Locations

CA (1)