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Completed

NCT Number: NCT05418998

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

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.

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Key information

Age range

45 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Concordia University

Montreal, Quebec, H3G 1M8, Canada

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

  • 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.

Treatment and study plan

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.

Primary outcomes

  1. Pre-training Change in auditory 2-back accuracy

    Time frame: baseline

    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.

  2. Post-training Change in auditory 2-back accuracy

    Time frame: after 12 weeks

    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.

  3. Pre-training Change in auditory 2-back reaction time

    Time frame: baseline

    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.

  4. Post-training Change in auditory 2-back reaction time

    Time frame: after 12 weeks

    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.

  5. Pre-training Multi-Talker word perception (accuracy)

    Time frame: baseline

    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.

  6. Post-training Multi-Talker word perception (accuracy)

    Time frame: after 12 weeks

    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.

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

    Time frame: baseline

    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.

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

    Time frame: after 12 weeks

    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.

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

    Time frame: baseline

    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.

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

    Time frame: after 12 weeks

    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.

Secondary outcomes

  1. Pre-training Montreal Cognitive Assessment (MoCA)

    Time frame: baseline

    Neuropsychological test to evaluate global cognitive status. Scored on 30, a score of 26 or higher is used to identify Mild Cognitive Impairment (MCI) however a score of 23 or higher is used in this study as this cut-off has been shown to lower false positivity. (Nasreddine et al., 2005)

  2. Post-training Montreal Cognitive Assessment (MoCA)

    Time frame: after 12 weeks

    Neuropsychological test to evaluate global cognitive status. Scored on 30, a score of 26 or higher is used to identify Mild Cognitive Impairment (MCI) however a score of 23 or higher is used in this study as this cut-off has been shown to lower false positivity. (Nasreddine et al., 2005)

  3. Pre-training WAIS-IV Digit Symbol Coding

    Time frame: baseline

    Neuropsychological test to evaluate processing speed. Subtest of the Wechsler Adult Intelligence Scale IV (WAIS; Wechsler, 2008). Scored based on correct number of symbols completed in 120 seconds.

  4. Post-training WAIS-IV Digit Symbol Coding

    Time frame: after 12 weeks

    Neuropsychological test to evaluate processing speed. Subtest of the Wechsler Adult Intelligence Scale IV (WAIS; Wechsler, 2008). Scored based on correct number of symbols completed in 120 seconds.

  5. Pre-training Trail Making Test

    Time frame: baseline

    Neuropsychological test to evaluate processing speed and executive functioning (Reitan, 1992). In form A, participants use a pencil to connect circles on a page in ascending numerical order. In form B, participants connect circles, alternating between ascending number and letter series. Time to complete (s) is recorded per form. Difference between Forms B and A completion times provides an index of switching, updating, and is considered a measure of executive function.

  6. Post-training Trail Making Test

    Time frame: after 12 weeks

    Neuropsychological test to evaluate processing speed and executive functioning (Reitan, 1992). In form A, participants use a pencil to connect circles on a page in ascending numerical order. In form B, participants connect circles, alternating between ascending number and letter series. Time to complete (s) is recorded per form. Difference between Forms B and A completion times provides an index of switching, updating, and is considered a measure of executive function.

  7. Pre-training D-KEFS Stroop

    Time frame: baseline

    Delis-Kaplan Executive Function System (D-KEFS) Color-Word Interference Test (CWIT) is a neuropsychological test to evaluate processing speed and executive functioning (adapted from Delis, Kaplan, & Kramer, 2001). A modification of the Stroop task (Stroop, 1935). In the CWIT, participants are asked to complete four conditions: colour naming, reading (both discontinued after 90 seconds), inhibition, and inhibition/switching (both discontinued after 180 seconds). Number correctly completed per condition.

  8. Post-training D-KEFS Stroop

    Time frame: after 12 weeks

    Delis-Kaplan Executive Function System (D-KEFS) Color-Word Interference Test (CWIT) is a neuropsychological test to evaluate processing speed and executive functioning (adapted from Delis, Kaplan, & Kramer, 2001). A modification of the Stroop task (Stroop, 1935). In the CWIT, participants are asked to complete four conditions: colour naming, reading (both discontinued after 90 seconds), inhibition, and inhibition/switching (both discontinued after 180 seconds). Number correctly completed per condition.

  9. Pre-training Rey Auditory Verbal Learning Test

    Time frame: baseline

    Neuropsychological test to evaluate verbal memory (RAVLT; Rey, A. (1941). Scored by: adding up to correctly recalled words for each trial to obtain immediate recall total; how many correctly recalled words after the 30-minute interval to obtain their delayed recall total; divided delayed recall total by the total words correctly recalled on the fifth (last) trial of the initial administration and multiplied by 100 to obtain their percentage retention value.

  10. Post-training Rey Auditory Verbal Learning Test

    Time frame: after 12 weeks

    Neuropsychological test to evaluate verbal memory (RAVLT; Rey, A. (1941). Scored by: adding up to correctly recalled words for each trial to obtain immediate recall total; how many correctly recalled words after the 30-minute interval to obtain their delayed recall total; divided delayed recall total by the total words correctly recalled on the fifth (last) trial of the initial administration and multiplied by 100 to obtain their percentage retention value.

  11. Pre-training WAIS-IV Digit span

    Time frame: baseline

    Neuropsychological test to evaluate short-term memory. Subtest of the Wechsler Adult Intelligence Scale IV (WAIS; Wechsler, 2008). Scored based on highest span length correctly completed.

  12. Post-training WAIS-IV Digit span

    Time frame: after 12 weeks

    Neuropsychological test to evaluate short-term memory. Subtest of the Wechsler Adult Intelligence Scale IV (WAIS; Wechsler, 2008). Scored based on highest span length correctly completed.

  13. Pre-training Subjective listening self efficacy

    Time frame: baseline

    Listening self-efficacy questionnaire (LSEQ: Smith, Pichora-Fuller, Watts, & La More, 2011, Int J Audiol). Asks questions about one's self-rated ability to understand conversation in a variety of contexts, without the use of hearing aids, self-rated self-efficacy (0-100%). Internal consistency (Chronbach's α) = .96 (Smith et al., 2011).

  14. Post-training Subjective listening self efficacy

    Time frame: after 12 weeks

    Listening self-efficacy questionnaire (LSEQ: Smith, Pichora-Fuller, Watts, & La More, 2011, Int J Audiol). Asks questions about one's self-rated ability to understand conversation in a variety of contexts, without the use of hearing aids. Internal consistency (Chronbach's α) = .96 (Smith et al., 2011).

  15. Pre-training Subjective balance confidence

    Time frame: baseline

    ABC Balance Confidence Questionnaire (Powell & Myers, 1995, J Geront: MedSci). Sixteen-item questionnaire concerning self-rated confidence (0-100%) balancing in different physical activities and contexts.

  16. Post-training Subjective balance confidence

    Time frame: after 12 weeks

    ABC Balance Confidence Questionnaire (Powell & Myers, 1995, J Geront: MedSci). Sixteen-item questionnaire concerning self-rated confidence (0-100%) balancing in different physical activities and contexts.

  17. Pre-training Mobility functioning as assessed by the Mini BESTest

    Time frame: baseline

    The Mini BESTest is comprised of four sub-scales to evaluate balance performance, including an anticipatory sub-scale (e.g., sit-to-stand, toe rise), a reactive postural control subscale (measures compensatory stepping when one's centre of balance is displaced in the forward, backward, or lateral position), a sensory orientation subscale (e.g., eyes closed, foam mat), and a gait subscale (e.g., walking over an obstacle).

  18. Post-training Mobility functioning as assessed by the Mini BESTest

    Time frame: after 12 weeks

    The Mini BESTest is comprised of four sub-scales to evaluate balance performance, including an anticipatory sub-scale (e.g., sit-to-stand, toe rise), a reactive postural control subscale (measures compensatory stepping when one's centre of balance is displaced in the forward, backward, or lateral position), a sensory orientation subscale (e.g., eyes closed, foam mat), and a gait subscale (e.g., walking over an obstacle).

  19. Pre-training Functional neuroimaging (fNIRS)

    Time frame: baseline

    Portable functional near infrared spectroscopy (BRITE MKII) will be used to assess prefrontal cortex activity during the single- and dual-task walking conditions. Sixteen detectors will be placed strategically 2.8 cm away from the optodes, eight of them will be dorsal to the optodes, while the other eight will be ventral, so that each probe has four dorsal detectors and four ventral detectors. The two probes will be placed symmetrically over the lateral prefrontal cortex and the most anterior and most ventral pair of optode-detector of each probe will be placed on Fp1/Fp2. The probes were designed based on existing configurations. Of interest are relative changes in concentration of frontal oxy-hemoglobin (HbO2: measured at absorption peak of 850nm) and deoxy-hemoglobin (HbR: measured at absorption peak of 735nm) compared to the baseline rest data.

  20. Post-training Functional neuroimaging (fNIRS)

    Time frame: after 12 weeks

    Portable functional near infrared spectroscopy (BRITE MKII) will be used to assess prefrontal cortex activity during the single- and dual-task walking conditions. Sixteen detectors will be placed strategically 2.8 cm away from the optodes, eight of them will be dorsal to the optodes, while the other eight will be ventral, so that each probe has four dorsal detectors and four ventral detectors. The two probes will be placed symmetrically over the lateral prefrontal cortex and the most anterior and most ventral pair of optode-detector of each probe will be placed on Fp1/Fp2. The probes were designed based on existing configurations. Of interest are relative changes in concentration of frontal oxy-hemoglobin (HbO2: measured at absorption peak of 850nm) and deoxy-hemoglobin (HbR: measured at absorption peak of 735nm) compared to the baseline rest data.

  21. Pre-training Standing Balance (Path length)

    Time frame: baseline

    Postural measures will include spatial measures (centre of pressure path length; cm) in the anterior-posterior (front and back) and medial-lateral (side-to-side) orientations.

  22. Pre-training Standing Balance (Velocity)

    Time frame: baseline

    Postural measures will include temporal measures (velocity; cm/s) in the anterior-posterior (front and back) and medial-lateral (side-to-side) orientations.

  23. Pre-training Standing Balance (Variability)

    Time frame: baseline

    Postural measures will include variability measures (root means square, standard deviation) in the anterior-posterior (front and back) and medial-lateral (side-to-side) orientations.

  24. Post-training Standing Balance (Path length)

    Time frame: after 12 weeks

    Postural measures will include spatial measures (centre of pressure path length; cm) in the anterior-posterior (front and back) and medial-lateral (side-to-side) orientations.

  25. Post-training Standing Balance (Velocity)

    Time frame: after 12 weeks

    Postural measures will include temporal measures (velocity; cm/s) in the anterior-posterior (front and back) and medial-lateral (side-to-side) orientations.

  26. Post-training Standing Balance (Variability)

    Time frame: after 12 weeks

    Postural measures will include variability measures (root means square, standard deviation) in the anterior-posterior (front and back) and medial-lateral (side-to-side) orientations.

Sponsors and collaborators

Lead sponsor

Concordia University, Montreal

Other

Collaborators

  • Canadian Institutes of Health Research (CIHR)

Registry information

Official study title

Training Cognition to Improve Mobility and Listening in Older Adults with Hearing Loss: Moving from Lab to Life

Acronym: HnW

Important dates

Study start
2020
Primary completion
2023
Study completion
2024
First posted
Jun 15, 2022
Registry last updated
Mar 14, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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