Cognitive Training to Improve Mobility in Middle-aged and Older Adults
NCT05418998, Not applicable, Completed, Concordia University, Montreal
Trial 10
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
| Field | Value | Source |
|---|---|---|
| Title | Cognitive Training to Improve Mobility in Middle-aged and Older Adults | ClinicalTrials.gov |
| NCT number | NCT05418998 | ClinicalTrials.gov |
| Status | Completed | ClinicalTrials.gov |
| Phases | Not applicable | ClinicalTrials.gov |
| Enrollment | 63 participants, actual | ClinicalTrials.gov |
| Lead sponsor | Concordia University, Montreal | ClinicalTrials.gov |
| Conditions | Aging, Age Related Hearing Loss | ClinicalTrials.gov |
| Interventions | Executive function (EF) training | ClinicalTrials.gov |
| First posted | 2022-06-15 | ClinicalTrials.gov |
| Last updated | 2025-03-14 | ClinicalTrials.gov |
Registered outcomes 36
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description | Source |
|---|---|---|---|---|
| Primary | Pre-training Change in auditory 2-back accuracy | 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. | ClinicalTrials.gov |
| Primary | Post-training Change in auditory 2-back accuracy | 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. | ClinicalTrials.gov |
| Primary | Pre-training Change in auditory 2-back reaction time | 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. | ClinicalTrials.gov |
| Primary | Post-training Change in auditory 2-back reaction time | 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. | ClinicalTrials.gov |
| Primary | Pre-training Multi-Talker word perception (accuracy) | 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. | ClinicalTrials.gov |
| Primary | Post-training Multi-Talker word perception (accuracy) | 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. | ClinicalTrials.gov |
| Primary | Pre-training Change in stride time (mean, standard deviation [SD] of stride time) | 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. | ClinicalTrials.gov |
| Primary | Post-training Change in stride time (mean, standard deviation [SD] of stride time) | 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. | ClinicalTrials.gov |
| Primary | Pre-training Change in stride time variability (mean, standard deviation [SD] of stride time) | 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. | ClinicalTrials.gov |
| Primary | Post-training Change in stride time variability (mean, standard deviation [SD] of stride time) | 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. | ClinicalTrials.gov |
| Secondary | Pre-training Montreal Cognitive Assessment (MoCA) | 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) | ClinicalTrials.gov |
| Secondary | Post-training Montreal Cognitive Assessment (MoCA) | 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) | ClinicalTrials.gov |
| Secondary | Pre-training WAIS-IV Digit Symbol Coding | 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. | ClinicalTrials.gov |
| Secondary | Post-training WAIS-IV Digit Symbol Coding | 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. | ClinicalTrials.gov |
| Secondary | Pre-training Trail Making Test | 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. | ClinicalTrials.gov |
| Secondary | Post-training Trail Making Test | 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. | ClinicalTrials.gov |
| Secondary | Pre-training D-KEFS Stroop | 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. | ClinicalTrials.gov |
| Secondary | Post-training D-KEFS Stroop | 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. | ClinicalTrials.gov |
| Secondary | Pre-training Rey Auditory Verbal Learning Test | 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. | ClinicalTrials.gov |
| Secondary | Post-training Rey Auditory Verbal Learning Test | 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. | ClinicalTrials.gov |
Outcomes 0
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as | Source |
|---|
Results by group 0
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units | Source |
|---|
Participant flow 0
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted | Source |
|---|
Adverse events 0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events | Source |
|---|
Adverse event totals 0
The totals the trial posted for each group.
| Total | Group | Affected | At risk | Source |
|---|
Papers 2
The papers the trial lists on ClinicalTrials.gov.
Grants 0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
| Project | Title | Principal investigators | Organization | Funder | Fiscal years | Source |
|---|
Trial comparisons 0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|
Tests 7
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
| Test | Named as | Source |
|---|---|---|
| 2-Back Task | Primary outcome | ConductCognition |
| Digit Span Test | Secondary outcome | ConductCognition |
| Stroop Color-Word Test | Secondary outcome | ConductCognition |
| Symbol Coding | Secondary outcome | ConductCognition |
| Trail Making Test A | Secondary outcome | ConductCognition |
| Trail Making Test B | Secondary outcome | ConductCognition |
| Verbal Learning | Secondary outcome | ConductCognition |
Source 5
| Field | Value | Source |
|---|---|---|
| Release | trials-2026-11-12-0.4.0 | ClinicalTrials.gov |
| Release manifest SHA-256 | 0f4a8d8c48aee2a7573ae0fa94ecbeab70c1adbe449bbc95c424bc7d3e97b9d4 | ClinicalTrials.gov |
| Registry capture | 2026-11-12 | ClinicalTrials.gov |
| Results copy, AACT | 2026-03-23 | ClinicalTrials.gov |
| NIH clinical studies file | 2026-11-13 | ClinicalTrials.gov |
Release trials-2026-11-12-0.4.0
ClinicalTrials.gov's posted results, through CTTI's AACT: ClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299 ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
ClinicalTrials.gov: none stated ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
NIH RePORTER's clinical studies and project files: Public domain (NIH RePORTER)