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

Aging Clinical Trial

— HnW  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05418998
• Other study ID #: 30011799
• Status: Recruiting
• Phase: N/A
• Start date: August 30, 2020
• Est. completion date: August 15, 2024

Study information

• Verified date: September 2023
• Source: Concordia University, Montreal
• Contact: Karen ZH Li, PhD
• Phone: 1-514-848-2424
• Email: karen.li[@]concordia.ca
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 120
• Est. completion date: August 15, 2024
• Est. primary completion date: August 15, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 45 Years to 80 Years

Eligibility

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.

Related Conditions & MeSH terms

• Age Related Hearing Loss
• Aging
• Deafness
• Hearing Loss
• Presbycusis

Intervention

Behavioral:
• Executive function (EF) training
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.

Locations

Country	Name	City	State
Canada	Concordia University	Montreal	Quebec

Sponsors (2)

Lead Sponsor	Collaborator
Concordia University, Montreal	Canadian Institutes of Health Research (CIHR)

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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	Pre-training Montreal Cognitive Assessment (MoCA)	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
Secondary	Post-training Montreal Cognitive Assessment (MoCA)	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
Secondary	Pre-training WAIS-IV Digit Symbol Coding	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
Secondary	Post-training WAIS-IV Digit Symbol Coding	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
Secondary	Pre-training Trail Making Test	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
Secondary	Post-training Trail Making Test	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
Secondary	Pre-training D-KEFS Stroop	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
Secondary	Post-training D-KEFS Stroop	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
Secondary	Pre-training Rey Auditory Verbal Learning Test	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
Secondary	Post-training Rey Auditory Verbal Learning Test	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
Secondary	Pre-training WAIS-IV Digit span	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
Secondary	Post-training WAIS-IV Digit span	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
Secondary	Pre-training Subjective listening self efficacy	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 a) = .96 (Smith et al., 2011).	baseline
Secondary	Post-training Subjective listening self efficacy	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 a) = .96 (Smith et al., 2011).	after 12 weeks
Secondary	Pre-training Subjective balance confidence	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
Secondary	Post-training Subjective balance confidence	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
Secondary	Pre-training Mobility functioning as assessed by the Mini BESTest	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
Secondary	Post-training Mobility functioning as assessed by the Mini BESTest	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
Secondary	Pre-training Functional neuroimaging (fNIRS)	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
Secondary	Post-training Functional neuroimaging (fNIRS)	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
Secondary	Pre-training Standing Balance (Path length)	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
Secondary	Pre-training Standing Balance (Velocity)	Postural measures will include temporal measures (velocity; cm/s) in the anterior-posterior (front and back) and medial-lateral (side-to-side) orientations.	baseline
Secondary	Pre-training Standing Balance (Variability)	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
Secondary	Post-training Standing Balance (Path length)	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
Secondary	Post-training Standing Balance (Velocity)	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
Secondary	Post-training Standing Balance (Variability)	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