- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05418998
Cognitive Training to Improve Mobility in Middle-aged and Older Adults (HnW)
September 21, 2023 updated by: Karen Li, Concordia University, Montreal
Training Cognition to Improve Mobility and Listening in Older Adults With Hearing Loss: Moving From Lab to Life
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.
Study Overview
Status
Recruiting
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Estimated)
120
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Karen ZH Li, PhD
- Phone Number: 7542 1-514-848-2424
- Email: karen.li@concordia.ca
Study Contact Backup
- Name: Monica Toca
- Phone Number: 2425 1-514-848-2424
- Email: monica.toca@concordia.ca
Study Locations
-
-
Quebec
-
Montreal, Quebec, Canada, H3G 1M8
- Recruiting
- Concordia University
-
Contact:
- Monica Toca
- Phone Number: 2425 1-514-848-2424
- Email: monica.toca@concordia.ca
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
45 years to 80 years (Adult, Older Adult)
Accepts Healthy Volunteers
Yes
Description
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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Executive function (EF) training
12 weeks of at-home EF training on a computer or iPad
|
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.
|
No Intervention: Wait-list control
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
|
baseline
|
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.
|
after 12 weeks
|
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.
|
baseline
|
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.
|
after 12 weeks
|
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.
|
baseline
|
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.
|
after 12 weeks
|
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.
|
baseline
|
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.
|
after 12 weeks
|
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.
|
baseline
|
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.
|
after 12 weeks
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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)
|
baseline
|
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)
|
after 12 weeks
|
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.
|
baseline
|
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.
|
after 12 weeks
|
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.
|
baseline
|
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.
|
after 12 weeks
|
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.
|
baseline
|
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.
|
after 12 weeks
|
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.
|
baseline
|
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.
|
after 12 weeks
|
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.
|
baseline
|
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.
|
after 12 weeks
|
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).
|
baseline
|
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).
|
after 12 weeks
|
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.
|
baseline
|
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.
|
after 12 weeks
|
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).
|
baseline
|
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).
|
after 12 weeks
|
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.
|
baseline
|
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.
|
after 12 weeks
|
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.
|
baseline
|
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.
|
baseline
|
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.
|
baseline
|
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.
|
after 12 weeks
|
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.
|
after 12 weeks
|
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.
|
after 12 weeks
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
August 30, 2020
Primary Completion (Estimated)
August 15, 2024
Study Completion (Estimated)
August 15, 2024
Study Registration Dates
First Submitted
May 26, 2022
First Submitted That Met QC Criteria
June 9, 2022
First Posted (Actual)
June 15, 2022
Study Record Updates
Last Update Posted (Actual)
September 25, 2023
Last Update Submitted That Met QC Criteria
September 21, 2023
Last Verified
September 1, 2023
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 30011799
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
YES
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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