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| ID | Type | Description | Link |
|---|---|---|---|
| K01AG049829 | U.S. NIH Grant/Contract | View source | |
| KL2TR001071 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Institute on Aging (NIA) | NIH |
| National Center for Advancing Translational Sciences (NCATS) | NIH |
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The investigators propose a single-blind randomized clinical trial to determine if seniors show improved mobility (walking speed) and cognition following motor imagery (imagined walking) training. They hypothesize that imagined walking can be used as a rehabilitative tool for improving walking speed and cognition in the elderly, because it engages and strengthens similar neural systems as actual walking and cognition.
The proposed research aims to establish the efficacy of an imagined gait protocol for improving gait and cognition in the elderly. This imagined gait protocol involves imagined gait in single (imagined walking; iW) and dual-task (imagined walking while talking; iWWT) situations. A single-blind randomized clinical trial of 58 cognitively-healthy elderly with pre-post measures of gait, cognition, and functional Magnetic Resonance Imaging (fMRI) during imagined gait is proposed. The overall hypothesis is that imagined gait can be used as a rehabilitative tool for improving gait and cognition in the elderly because it engages and strengthens similar neural systems as actual gait and cognition. The first aim of this study is to establish the efficacy of our imagined gait protocol to improve gait and cognition in the elderly. We predict that our imagined gait intervention will improve gait velocity during actual walking and walking-while-talking conditions to a greater extent than the active control (visual imagery) intervention. We also predict that our imagined gait intervention will cognitive performance during dual-task walking conditions. The second aim of this study is to determine neuroplasticity changes in response to our imagined gait protocol. We predict that the neural systems engaged during imagined gait will change following our imagined gait intervention.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Imagined Gait Intervention | Experimental | During the phone-based imagined gait intervention, participants will be called by the experimenter three times a week and be asked to imagine walking, imagine talking and imagine walking-while-talking. They will also be asked to rate their visual and kinesthetic qualities of their images on a 1-5 scale following each trial. |
|
| Visual Imagery Intervention | Active Comparator | During the phone-based visual imagery intervention, participants will be called three times a week by the experimenter and be asked to imagine concrete objects (e.g. octopus, teapot, and shovel). They will also be asked to rate their visual qualities of their images on a 1-5 scale following each trial. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Imagined Gait Intervention | Behavioral | Phone-based imagined gait intervention: participants will be called by the experimenter three times a week and be asked to imagine walking, imagine talking and imagine walking-while-talking. They will also be asked to rate their visual and kinesthetic qualities of their images on a 1-5 scale following each trial. |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Walking Speed During Single and Dual-task Walking Conditions | Change in gait speed (centimeters per second) measured during normal pace walking and walking while talking conditions using an instrumented pathway. A positive mean value is indicative of an improvement (increase) in gait speed post-intervention, whereas a negative mean value is indicative of a decrease in gait speed post-intervention. | Baseline and 3 months |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Cognitive Performance During Walking While Talking | Change in cognitive performance was assessed by the number of correct letters/time (in seconds) generated during walking while talking (WWT). This exercise consists of having the participant walk around a computerized walkway while reciting alternate letters of the alphabet (WWT), starting with the letter "B." A positive mean value reflects an improvement in cognitive performance (increase in the number of correct letters/time generated) post-intervention; whereas, a negative mean value reflects worsening in cognitive performance (decrease in the number of correct letters/time generated) post-intervention. |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Free Cued Serial Recall Test | Changes in free recall performance were based on the free cued serial recall test, a measure of verbal learning and memory. Scores range from 0 to 48. Mean values reflect the change in the number of items recalled pre and post intervention. A positive mean value indicates improved recall performance post intervention whereas a negative mean value reflects decreased performance post intervention. |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Helena M Blumen, Ph.D | Albert Einstein College of Medicine | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Albert Einstein College of Medicine | The Bronx | New York | 10461 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 29165011 | Derived | Blumen HM, Verghese J. Motor imagery of walking and walking while talking: a pilot randomized-controlled trial protocol for older adults. Neurodegener Dis Manag. 2017 Dec;7(6):353-363. doi: 10.2217/nmt-2017-0024. Epub 2017 Nov 22. |
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Randomization goal was 48 but two extra randomization slots were added as a buffer. Once 24 in each condition had been randomized, recruitment stopped, resulting in a total of 49 randomized participants.
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| ID | Title | Description |
|---|---|---|
| FG000 | Imagined Gait Intervention | During the phone-based imagined gait intervention, participants will be called by the experimenter three times a week and be asked to imagine walking, imagine talking and imagine walking-while-talking. They will also be asked to rate their visual and kinesthetic qualities of their images on a 1-5 scale following each trial. Imagined Gait Intervention: Phone-based imagined gait intervention: participants will be called by the experimenter three times a week and be asked to imagine walking, imagine talking and imagine walking-while-talking. They will also be asked to rate their visual and kinesthetic qualities of their images on a 1-5 scale following each trial. |
| FG001 | Visual Imagery Intervention | During the phone-based visual imagery intervention, participants will be called three times a week by the experimenter and be asked to imagine concrete objects (e.g. octopus, teapot, and shovel). They will also be asked to rate their visual qualities of their images on a 1-5 scale following each trial. Visual Imagery Intervention: Phone-based visual imagery intervention: participants will be called three times a week by the experimenter and be asked to imagine concrete objects (e.g. octopus, teapot, and shovel). They will also be asked to rate their visual qualities of their images on a 1-5 scale following each trial. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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| ID | Title | Description |
|---|---|---|
| BG000 | Imagined Gait Intervention | During the phone-based imagined gait intervention, participants will be called by the experimenter three times a week and be asked to imagine walking, imagine talking and imagine walking-while-talking. They will also be asked to rate their visual and kinesthetic qualities of their images on a 1-5 scale following each trial. Imagined Gait Intervention: Phone-based imagined gait intervention: participants will be called by the experimenter three times a week and be asked to imagine walking, imagine talking and imagine walking-while-talking. They will also be asked to rate their visual and kinesthetic qualities of their images on a 1-5 scale following each trial. |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Change in Walking Speed During Single and Dual-task Walking Conditions | Change in gait speed (centimeters per second) measured during normal pace walking and walking while talking conditions using an instrumented pathway. A positive mean value is indicative of an improvement (increase) in gait speed post-intervention, whereas a negative mean value is indicative of a decrease in gait speed post-intervention. | Overall number of participants analyzed includes all randomized participants with baseline measures. Data was unable to be analyzed for 14 participants in the Visual Imagery group due to a protocol deviation (incorrect intervention procedure). | Posted | Mean | Standard Deviation | centimeters per second | Baseline and 3 months |
|
3 months
Participants were queried weekly about falls and any changes to their health.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Imagined Gait Intervention | During the phone-based imagined gait intervention, participants will be called by the experimenter three times a week and be asked to imagine walking, imagine talking and imagine walking-while-talking. They will also be asked to rate their visual and kinesthetic qualities of their images on a 1-5 scale following each trial. Imagined Gait Intervention: Phone-based imagined gait intervention: participants will be called by the experimenter three times a week and be asked to imagine walking, imagine talking and imagine walking-while-talking. They will also be asked to rate their visual and kinesthetic qualities of their images on a 1-5 scale following each trial. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Pneumonia | Infections and infestations | Systematic Assessment | Participant was recruited into the study 06/01/2021 and completed 21 intervention sessions prior to onset. Participant was diagnosed with pneumonia on 8/8/2021 and was hospitalized for treatment. Participant resumed intervention calls on 9/13/21 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anemia | Blood and lymphatic system disorders | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Helena Blumen | Albert Einstein College of Medicine | 7184303810 | helena.blumen@einsteinmed.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Jun 16, 2017 | Mar 22, 2024 | Prot_SAP_000.pdf |
| ICF | No | No | Yes | Informed Consent Form | Sep 15, 2021 | Feb 26, 2024 | ICF_001.pdf |
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| ID | Term |
|---|---|
| D009043 | Motor Activity |
| ID | Term |
|---|---|
| D001519 | Behavior |
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|
| Visual Imagery Intervention | Behavioral | Phone-based visual imagery intervention: participants will be called three times a week by the experimenter and be asked to imagine concrete objects (e.g. octopus, teapot, and shovel). They will also be asked to rate their visual qualities of their images on a 1-5 scale following each trial. |
|
| Baseline and 3 months |
| Change in Blood-oxygen-level-dependent (BOLD) Signal During Dual-task Imagined Walking While Talking (iWWT) Conditions | Change in blood-oxygen-level-dependent (BOLD) signal (neuroplasticity) during imagined walking and walking while talking (iWWT) conditions were measured using functional magnetic resonance imaging (fMRI). The mean values reported are changes in factor scores that reflect the overall change in BOLD signal pre- to post-intervention. Positive values reflect an increase in BOLD signal post-intervention, whereas, negative mean values reflect a decrease in BOLD signal post intervention. There are no minimum or maximum values or ranges or thresholds associated with the BOLD measure. | Baseline and 3 months |
| Change in Trail Making Test Form A | Change in Trail Making Test Form A (TMT-A), is a timed measurement of attention and processing speed. Scoring is based on the time required to complete the task (i.e., drawing a line between 24 consecutive circles randomly arranged on a page) and ranges from 0-300 seconds with shorter time indicating better performance. A negative mean difference reflects an improvement pre to post intervention. The TMT-A uses all numbers (no letters) and includes correction of errors prompted by the examiner. | Baseline and 3 months |
| Change in Trail Making Test Form B | Change in Trail Making Test, Form B (TMT-B), is a timed measurement of attention, processing speed, and set-shifting. Scoring is based on the time required to complete the task (i.e., drawing a line between 24 consecutive circles randomly arranged on a page) and ranges from 0-300 seconds with shorter times indicating better performance. A negative mean difference reflects an improvement pre to post intervention. The TMT-B alternates between numbers and letters requiring the participant to switch between numbers and letters in consecutive order and includes correction of errors prompted by the examiner. | Baseline and 3 months |
| Change in Trail Making Test Form B Minus Form A | Change in Trail Making Test Form B (TMT-B) minus Form A (TMT-A), a timed measure of set-shifting. Scoring is based on the change in time between completing Form B compared to Form A. A negative mean difference reflects an improvement post intervention. | Baseline and 3 months |
| Change in Letter Number Sequencing Task Score | Change in scoring in the letter number sequencing task, a measure of item manipulation, was derived from the letter number sequencing subtest of the working memory domain within the Wechsler Adult Intelligence Scale (WAIS) III battery, a widely used intelligence test for adults. Scoring is based on the number of correctly sequenced letters and numbers with increasing (positive) mean scores indicating an improvement in task performance post intervention. A negative mean score reflects a decrease in task performance post intervention. | Baseline and 3 months |
| Change in Stroop Interference Test: Color-Word Minus Color Score | Change in Stroop Interference Test: Color-Word (incongruent trials) minus Color (congruent trials) scores were determined. It is a measure of response competition and interference. Scoring is based on the time it takes to read (complete) incongruent trials relative to congruent trials. A negative mean value reflects an improvement in performance after the intervention. A positive mean value reflects an decrease in performance after the intervention. | Baseline and 3 months |
| Change in Flanker Interference Task | Change in the Flanker Interference Task measures how much interference is generated by the presentation of adjacent incongruent and congruent visual information. Scoring is based on the difference in reaction time (in milliseconds) between incongruent and congruent trials responded to correctly. A negative mean is indicative of improved interference post intervention and a positive mean value is indicative of worsening interference post intervention. | Baseline and 3 months |
| Change in Stride Length | Change in stride length were collected during walking while talking (WWT) conditions on an instrumented walkway. Stride length was defined as the distance between the heel points of 2 consecutive footfalls of the same foot and measured in centimeters (cm). | Baseline and 3 months |
| Change in Gait Variability | Change in gait variability is collected during walking while talking on an instrumented walkway. Gait variability, defined as the stride-to-stride fluctuations in walking, was measured by the coefficient of variation (CV) of the mean value of stride-to stride time. CV reflects the level of gait rhythmicity, with lower values indicating greater rhythmicity. A negative mean CV reflects improved (less) variability post intervention whereas a positive mean CV value reflects worse (increased) variability. Stride time CV is closely associated with falls | Baseline and 3 months |
| Change in Gait Domains | Change in gait domains (summary measures reported in standard deviation units) derived from factor analysis of quantitative gait variables collected on an instrumented walkway during normal pace walking and walking while talking. Gait domain score is calculated by summing ratings for individual items and dividing by the maximum possible score for the domain, then multiplying by 100. The domain score ranges from 0 to 100, with higher scores reflecting more gait disturbance and lower scores reflecting less gait disturbance. | Baseline and 3 months |
| Baseline and 3 months |
| Change in Delayed Figure Copy Recall on Repeatable Battery for the Assessment of Neuropsychological Status (RBANS) | Change in delayed figure copy recall performance from the RBANS assessment, a measure of spatial learning and memory. Figure copy recall scores range from 0 to 20. A positive mean is indicative of an increase in recall post intervention whereas a negative mean is indicative of a decrease in recall post intervention. | Baseline and 3 months |
| Change in Controlled Oral Word Fluency Test | Change in the number of correct words generated on the controlled oral word fluency test, a measure of language processing. Scores range from 0 to 36. A positive mean reflects an improvement in language processing post intervention whereas a negative mean reflects worsening of language processing post intervention | Baseline and 3 months |
| Change in Semantic Fluency Test | Change in the total number of correct words generated for each category on the semantic fluency test, a measure of language processing. Scores reflect the number of correct items generated in a 60 second window. A positive mean value reflects improved semantic fluency post intervention and a negative mean value reflects worsening of semantic fluency post intervention. | Baseline and 3 months |
| Change in Digit Symbol Substitution | Change in number of correct digit symbols generated on the digit symbol substitution test (DSST), a measure of processing speed, attention and working memory. The number of correct symbols within the allowed time in seconds is measured. A positive mean reflects an improvement in the number of correct digit symbols generated post intervention whereas a negative mean value reflects fewer correct digits generated post intervention. | Baseline and 3 months |
| Modified Short Physical Performance Battery (SPPB) at Baseline | SPPB is a measure of lower extremity function and includes a balance test, a chair stand test and a gait speed test. Because gait speed/velocity was our primary outcome, only administered the balance and chair stand tests were administered. Thus, possible scores range from 0-8 (rather than the typical 0-12) with 0 being worst performance and 8 being best performance. | Baseline |
| Change in Immediate Maze Task Performance | Change in mean immediate maze performance (time in seconds), a measure of spatial navigation and memory, were determined. A negative mean value represents an improvement in immediate maze performance post intervention whereas a positive mean value represents worsening of maze performance post intervention. | Baseline and 3 months |
| Change in Delayed Maze Task Performance | Change in mean delayed maze performance (time in seconds), a measurement of spatial navigation and memory, were determined. A negative mean value represents an improvement in delayed maze performance post intervention, whereas a positive mean performance time represents worsening delayed maze performance post intervention | Baseline and 3 months |
| Change in Errors on Maze Task | The number of errors during maze performance, a measure of spatial navigation and memory, will be assessed. A negative mean result is indicative of an improvement (fewer errors) post intervention whereas a positive mean result is indicative of a reduction in performance (more errors) post intervention. | Baseline and 3 months |
| Change in Geriatric Depression Scale | The Geriatric Depression Scale (GDS) will be used to to determine mean changes in depressive symptoms from baseline. Scores range from 0 to 30. Scores of 0 - 9 are considered normal, 10 - 19 indicate mild depression and 20 30 indicate severe depression. As such, higher scores are indicative of more severe depressive symptoms. A positive mean value reflects an increase in depressive symptoms post-intervention whereas a negative value reflects a decrease in depressive symptoms post intervention. | Baseline and 3 months |
| Change in Beck Anxiety Inventory | Change in symptoms of anxiety. Scores range from 0 to 84 with higher values reflecting more anxiety symptoms. A negative mean reflects a reduction in anxiety symptoms post intervention and a positive mean value reflects an increase in anxiety symptoms post intervention | Baseline and 3 months |
| Change in Gray Matter Cortical Thickness | Change in mean Cortical Thickness obtained from T1-weighted structural images. A positive mean value reflects an increase in cortical thickness post intervention and a negative mean value reflects a decrease in cortical thickness post intervention | Baseline and 3 months |
| Change in White Matter Integrity | Change in White Matter Integrity obtained from diffusion-weighted imaging. Increased white matter integrity is associated with improved cognitive performance whereas decreased white matter integrity is associated with decreased cognitive performance. | Baseline and 3 months |
| Change in White Matter Hyperintensities | Change in White Matter Hyperintensities obtained from Fluid-Attenuated Inversion Recovery imaging. Increased white matter hyperintensities may be indicative of unfavorable outcomes. | Baseline and 3 months |
| BG001 | Visual Imagery Intervention | During the phone-based visual imagery intervention, participants will be called three times a week by the experimenter and be asked to imagine concrete objects (e.g. octopus, teapot, and shovel). They will also be asked to rate their visual qualities of their images on a 1-5 scale following each trial. Visual Imagery Intervention: Phone-based visual imagery intervention: participants will be called three times a week by the experimenter and be asked to imagine concrete objects (e.g. octopus, teapot, and shovel). They will also be asked to rate their visual qualities of their images on a 1-5 scale following each trial. |
| BG002 | Total | Total of all reporting groups |
| years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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| Years of Education | Years of education for one participant in the Visual Imagery (VI) Intervention condition was missing | Mean | Standard Deviation | years |
|
| OG001 | Visual Imagery Intervention | During the phone-based visual imagery intervention, participants will be called three times a week by the experimenter and be asked to imagine concrete objects (e.g. octopus, teapot, and shovel). They will also be asked to rate their visual qualities of their images on a 1-5 scale following each trial. Visual Imagery Intervention: Phone-based visual imagery intervention: participants will be called three times a week by the experimenter and be asked to imagine concrete objects (e.g. octopus, teapot, and shovel). They will also be asked to rate their visual qualities of their images on a 1-5 scale following each trial. |
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| Secondary | Change in Cognitive Performance During Walking While Talking | Change in cognitive performance was assessed by the number of correct letters/time (in seconds) generated during walking while talking (WWT). This exercise consists of having the participant walk around a computerized walkway while reciting alternate letters of the alphabet (WWT), starting with the letter "B." A positive mean value reflects an improvement in cognitive performance (increase in the number of correct letters/time generated) post-intervention; whereas, a negative mean value reflects worsening in cognitive performance (decrease in the number of correct letters/time generated) post-intervention. | Overall number of participants analyzed includes all randomized participants with baseline measures. Data was unable to be analyzed for 14 participants in the Visual Imagery group due to a protocol deviation (incorrect intervention procedure). Data was also unable to be analyzed for 2 participants in the Visual Imagery group and 7 participants in the Imagined Gait group due to missing data. | Posted | Mean | Standard Deviation | correct letters/second | Baseline and 3 months |
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| Secondary | Change in Blood-oxygen-level-dependent (BOLD) Signal During Dual-task Imagined Walking While Talking (iWWT) Conditions | Change in blood-oxygen-level-dependent (BOLD) signal (neuroplasticity) during imagined walking and walking while talking (iWWT) conditions were measured using functional magnetic resonance imaging (fMRI). The mean values reported are changes in factor scores that reflect the overall change in BOLD signal pre- to post-intervention. Positive values reflect an increase in BOLD signal post-intervention, whereas, negative mean values reflect a decrease in BOLD signal post intervention. There are no minimum or maximum values or ranges or thresholds associated with the BOLD measure. | Overall number of participants analyzed includes all randomized participants with baseline measures. Data was unable to be analyzed for 14 participants in the Visual Imagery group due to a protocol deviation (incorrect intervention procedure). Data was also unable to be analyzed for 2 participants in the Visual Imagery group and 2 participants in the Imagined Gait group due to incomplete tasks/sessions or corrupted data files. | Posted | Mean | Standard Deviation | Factor score for BOLD signal | Baseline and 3 months |
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| Secondary | Change in Trail Making Test Form A | Change in Trail Making Test Form A (TMT-A), is a timed measurement of attention and processing speed. Scoring is based on the time required to complete the task (i.e., drawing a line between 24 consecutive circles randomly arranged on a page) and ranges from 0-300 seconds with shorter time indicating better performance. A negative mean difference reflects an improvement pre to post intervention. The TMT-A uses all numbers (no letters) and includes correction of errors prompted by the examiner. | Overall number of participants analyzed includes all randomized participants with baseline measures. Data was unable to be analyzed for 14 participants in the Visual Imagery group due to a protocol deviation (incorrect intervention procedure). | Posted | Mean | Standard Deviation | seconds | Baseline and 3 months |
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| Secondary | Change in Trail Making Test Form B | Change in Trail Making Test, Form B (TMT-B), is a timed measurement of attention, processing speed, and set-shifting. Scoring is based on the time required to complete the task (i.e., drawing a line between 24 consecutive circles randomly arranged on a page) and ranges from 0-300 seconds with shorter times indicating better performance. A negative mean difference reflects an improvement pre to post intervention. The TMT-B alternates between numbers and letters requiring the participant to switch between numbers and letters in consecutive order and includes correction of errors prompted by the examiner. | Overall number of participants analyzed includes all randomized participants with baseline measures. Data was unable to be analyzed for 14 participants in the Visual Imagery group due to a protocol deviation (incorrect intervention procedure). | Posted | Mean | Standard Deviation | seconds | Baseline and 3 months |
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| Secondary | Change in Trail Making Test Form B Minus Form A | Change in Trail Making Test Form B (TMT-B) minus Form A (TMT-A), a timed measure of set-shifting. Scoring is based on the change in time between completing Form B compared to Form A. A negative mean difference reflects an improvement post intervention. | Overall number of participants analyzed includes all randomized participants with baseline measures. Data was unable to be analyzed for 14 participants in the Visual Imagery group due to a protocol deviation (incorrect intervention procedure). | Posted | Mean | Standard Deviation | seconds | Baseline and 3 months |
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| Secondary | Change in Letter Number Sequencing Task Score | Change in scoring in the letter number sequencing task, a measure of item manipulation, was derived from the letter number sequencing subtest of the working memory domain within the Wechsler Adult Intelligence Scale (WAIS) III battery, a widely used intelligence test for adults. Scoring is based on the number of correctly sequenced letters and numbers with increasing (positive) mean scores indicating an improvement in task performance post intervention. A negative mean score reflects a decrease in task performance post intervention. | Overall number of participants analyzed includes all randomized participants with baseline measures. Data was unable to be analyzed for 14 participants in the Visual Imagery group due to a protocol deviation (incorrect intervention procedure). | Posted | Mean | Standard Deviation | Correct sequences | Baseline and 3 months |
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| Secondary | Change in Stroop Interference Test: Color-Word Minus Color Score | Change in Stroop Interference Test: Color-Word (incongruent trials) minus Color (congruent trials) scores were determined. It is a measure of response competition and interference. Scoring is based on the time it takes to read (complete) incongruent trials relative to congruent trials. A negative mean value reflects an improvement in performance after the intervention. A positive mean value reflects an decrease in performance after the intervention. | Overall number of participants analyzed includes all randomized participants with baseline measures. Data was unable to be analyzed for 14 participants in the Visual Imagery group due to a protocol deviation (incorrect intervention procedure) and for 1 participant in the Imagined Gait group due to missing data. | Posted | Mean | Standard Deviation | seconds | Baseline and 3 months |
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| Secondary | Change in Flanker Interference Task | Change in the Flanker Interference Task measures how much interference is generated by the presentation of adjacent incongruent and congruent visual information. Scoring is based on the difference in reaction time (in milliseconds) between incongruent and congruent trials responded to correctly. A negative mean is indicative of improved interference post intervention and a positive mean value is indicative of worsening interference post intervention. | Overall number of participants analyzed includes all randomized participants with baseline measures. Data was unable to be analyzed for 14 participants in the Visual Imagery group due to a protocol deviation (incorrect intervention procedure). Data was also unable to be analyzed for 7 participants in the Visual Imagery Group and 13 participants in the Imagined Gait group due to incomplete tasks/sessions or corrupted data files. | Posted | Mean | Standard Deviation | milliseconds | Baseline and 3 months |
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| Secondary | Change in Stride Length | Change in stride length were collected during walking while talking (WWT) conditions on an instrumented walkway. Stride length was defined as the distance between the heel points of 2 consecutive footfalls of the same foot and measured in centimeters (cm). | Overall number of participants analyzed includes all randomized participants with baseline measures. Data was unable to be analyzed for 14 participants in the Visual Imagery group due to a protocol deviation (incorrect intervention procedure). Data was also unable to be analyzed for 1 participant in the Visual Imagery group and 6 participants in the Imagined Gait group due to missing data or corrupted data files. | Posted | Mean | Standard Deviation | centimeters | Baseline and 3 months |
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| Secondary | Change in Gait Variability | Change in gait variability is collected during walking while talking on an instrumented walkway. Gait variability, defined as the stride-to-stride fluctuations in walking, was measured by the coefficient of variation (CV) of the mean value of stride-to stride time. CV reflects the level of gait rhythmicity, with lower values indicating greater rhythmicity. A negative mean CV reflects improved (less) variability post intervention whereas a positive mean CV value reflects worse (increased) variability. Stride time CV is closely associated with falls | Overall number of participants analyzed includes all randomized participants with baseline measures. Data was unable to be analyzed for 14 participants in the Visual Imagery group due to a protocol deviation (incorrect intervention procedure). Data was also unable to be analyzed for 1 participant in the Visual Imagery group and 6 participants in the Imagined Gait group due to missing data or corrupted data files. | Posted | Mean | Standard Deviation | Coefficient of Variation (CV) | Baseline and 3 months |
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| Secondary | Change in Gait Domains | Change in gait domains (summary measures reported in standard deviation units) derived from factor analysis of quantitative gait variables collected on an instrumented walkway during normal pace walking and walking while talking. Gait domain score is calculated by summing ratings for individual items and dividing by the maximum possible score for the domain, then multiplying by 100. The domain score ranges from 0 to 100, with higher scores reflecting more gait disturbance and lower scores reflecting less gait disturbance. | Data were unable to be accurately computed for Gait Domain outcome measure due to incomplete data collection of the individual gait variable measurements which would have been summed to generate a Gait Domain Score. Since there was not enough data overall for the models to converge Gait Domain data was not able to be collected. | Posted | Baseline and 3 months |
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| Other Pre-specified | Change in Free Cued Serial Recall Test | Changes in free recall performance were based on the free cued serial recall test, a measure of verbal learning and memory. Scores range from 0 to 48. Mean values reflect the change in the number of items recalled pre and post intervention. A positive mean value indicates improved recall performance post intervention whereas a negative mean value reflects decreased performance post intervention. | Overall number of participants analyzed includes all randomized participants with baseline measures. Data was unable to be analyzed for 14 participants in the Visual Imagery group due to a protocol deviation (incorrect intervention procedure). | Posted | Mean | Standard Deviation | correct items recalled | Baseline and 3 months |
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| Other Pre-specified | Change in Delayed Figure Copy Recall on Repeatable Battery for the Assessment of Neuropsychological Status (RBANS) | Change in delayed figure copy recall performance from the RBANS assessment, a measure of spatial learning and memory. Figure copy recall scores range from 0 to 20. A positive mean is indicative of an increase in recall post intervention whereas a negative mean is indicative of a decrease in recall post intervention. | Overall number of participants analyzed includes all randomized participants with baseline measures. Data was unable to be analyzed for 14 participants in the Visual Imagery group due to a protocol deviation (incorrect intervention procedure). | Posted | Mean | Standard Deviation | correct items recalled | Baseline and 3 months |
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| Other Pre-specified | Change in Controlled Oral Word Fluency Test | Change in the number of correct words generated on the controlled oral word fluency test, a measure of language processing. Scores range from 0 to 36. A positive mean reflects an improvement in language processing post intervention whereas a negative mean reflects worsening of language processing post intervention | Overall number of participants analyzed includes all randomized participants with baseline measures. Data was unable to be analyzed for 14 participants in the Visual Imagery group due to a protocol deviation (incorrect intervention procedure). | Posted | Mean | Standard Deviation | correct items generated | Baseline and 3 months |
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| Other Pre-specified | Change in Semantic Fluency Test | Change in the total number of correct words generated for each category on the semantic fluency test, a measure of language processing. Scores reflect the number of correct items generated in a 60 second window. A positive mean value reflects improved semantic fluency post intervention and a negative mean value reflects worsening of semantic fluency post intervention. | Overall number of participants analyzed includes all randomized participants with baseline measures. Data was unable to be analyzed for 14 participants in the Visual Imagery group due to a protocol deviation (incorrect intervention procedure). | Posted | Mean | Standard Deviation | correct words/minute | Baseline and 3 months |
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| Other Pre-specified | Change in Digit Symbol Substitution | Change in number of correct digit symbols generated on the digit symbol substitution test (DSST), a measure of processing speed, attention and working memory. The number of correct symbols within the allowed time in seconds is measured. A positive mean reflects an improvement in the number of correct digit symbols generated post intervention whereas a negative mean value reflects fewer correct digits generated post intervention. | Overall number of participants analyzed includes all randomized participants with baseline measures. Please note that data was unable to be analyzed for 14 participants in the Visual Imagery group due to a protocol deviation (incorrect intervention procedure). Data was also unable to be analyzed for 1 participant in the Imagined Gait group due to missing data. | Posted | Mean | Standard Deviation | correct digit symbols | Baseline and 3 months |
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| Other Pre-specified | Modified Short Physical Performance Battery (SPPB) at Baseline | SPPB is a measure of lower extremity function and includes a balance test, a chair stand test and a gait speed test. Because gait speed/velocity was our primary outcome, only administered the balance and chair stand tests were administered. Thus, possible scores range from 0-8 (rather than the typical 0-12) with 0 being worst performance and 8 being best performance. | SPPB was only administered at baseline (only the balance and chair tests were administered). Change analyses were not performed. | Posted | Mean | Standard Deviation | score on a scale | Baseline |
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| Other Pre-specified | Change in Immediate Maze Task Performance | Change in mean immediate maze performance (time in seconds), a measure of spatial navigation and memory, were determined. A negative mean value represents an improvement in immediate maze performance post intervention whereas a positive mean value represents worsening of maze performance post intervention. | Overall number of participants analyzed includes all randomized participants with baseline measures. Data was unable to be analyzed for 14 participants in the Visual Imagery group due to a protocol deviation (incorrect intervention procedure). Data was also unable to be analyzed for 5 participants in the in the Imagined Gait group due to missing data. | Posted | Mean | Standard Deviation | seconds | Baseline and 3 months |
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| Other Pre-specified | Change in Delayed Maze Task Performance | Change in mean delayed maze performance (time in seconds), a measurement of spatial navigation and memory, were determined. A negative mean value represents an improvement in delayed maze performance post intervention, whereas a positive mean performance time represents worsening delayed maze performance post intervention | Overall number of participants analyzed includes all randomized participants with baseline measures. Data was unable to be analyzed for 14 participants in the Visual Imagery group due to a protocol deviation (incorrect intervention procedure). Data was also unable to be analyzed for 4 participants in the in the Imagined Gait group due to missing data. | Posted | Mean | Standard Deviation | seconds | Baseline and 3 months |
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| Other Pre-specified | Change in Errors on Maze Task | The number of errors during maze performance, a measure of spatial navigation and memory, will be assessed. A negative mean result is indicative of an improvement (fewer errors) post intervention whereas a positive mean result is indicative of a reduction in performance (more errors) post intervention. | Overall number of participants analyzed includes all randomized participants with baseline measures. Data was unable to be analyzed for 14 participants in the Visual Imagery group due to a protocol deviation (incorrect intervention procedure). Data was also unable to be analyzed for 5 participants in the in the Imagined Gait group due to missing data. | Posted | Mean | Standard Deviation | errors | Baseline and 3 months |
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| Other Pre-specified | Change in Geriatric Depression Scale | The Geriatric Depression Scale (GDS) will be used to to determine mean changes in depressive symptoms from baseline. Scores range from 0 to 30. Scores of 0 - 9 are considered normal, 10 - 19 indicate mild depression and 20 30 indicate severe depression. As such, higher scores are indicative of more severe depressive symptoms. A positive mean value reflects an increase in depressive symptoms post-intervention whereas a negative value reflects a decrease in depressive symptoms post intervention. | Overall number of participants analyzed includes all randomized participants with baseline measures. Data was unable to be analyzed for 14 participants in the Visual Imagery group due to a protocol deviation (incorrect intervention procedure). Data was also unable to be analyzed for 3 participants in the in the Imagined Gait group and 2 participants in the in the Visual Imagery group due to missing data. | Posted | Mean | Standard Deviation | score on a scale | Baseline and 3 months |
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| Other Pre-specified | Change in Beck Anxiety Inventory | Change in symptoms of anxiety. Scores range from 0 to 84 with higher values reflecting more anxiety symptoms. A negative mean reflects a reduction in anxiety symptoms post intervention and a positive mean value reflects an increase in anxiety symptoms post intervention | Overall number of participants analyzed includes all randomized participants with baseline measures. Data was unable to be analyzed for 14 participants in the Visual Imagery group due to a protocol deviation (incorrect intervention procedure). Data was also unable to be analyzed for 6 participants in the in the Imagined Gait group and 2 participants in the in the Visual Imagery group due to missing data. | Posted | Mean | Standard Deviation | score on a scale | Baseline and 3 months |
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| Other Pre-specified | Change in Gray Matter Cortical Thickness | Change in mean Cortical Thickness obtained from T1-weighted structural images. A positive mean value reflects an increase in cortical thickness post intervention and a negative mean value reflects a decrease in cortical thickness post intervention | Overall number of participants analyzed includes all randomized participants with baseline measures. Data was unable to be analyzed for 14 participants in the Visual Imagery group due to a protocol deviation (incorrect intervention procedure). Data was also unable to be analyzed for 2 participants in the in the Visual Imagery group due to missing data. | Posted | Mean | Standard Deviation | millimeters | Baseline and 3 months |
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| Other Pre-specified | Change in White Matter Integrity | Change in White Matter Integrity obtained from diffusion-weighted imaging. Increased white matter integrity is associated with improved cognitive performance whereas decreased white matter integrity is associated with decreased cognitive performance. | Results were unable to be computed for White Matter Integrity due to limited data. | Posted | Baseline and 3 months |
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| Other Pre-specified | Change in White Matter Hyperintensities | Change in White Matter Hyperintensities obtained from Fluid-Attenuated Inversion Recovery imaging. Increased white matter hyperintensities may be indicative of unfavorable outcomes. | Results were unable to be computed for White Matter Hyperintensities due to limited data. | Posted | Baseline and 3 months |
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| 0 |
| 25 |
| 0 |
| 25 |
| 5 |
| 25 |
| EG001 | Visual Imagery Intervention | During the phone-based visual imagery intervention, participants will be called three times a week by the experimenter and be asked to imagine concrete objects (e.g. octopus, teapot, and shovel). They will also be asked to rate their visual qualities of their images on a 1-5 scale following each trial. Visual Imagery Intervention: Phone-based visual imagery intervention: participants will be called three times a week by the experimenter and be asked to imagine concrete objects (e.g. octopus, teapot, and shovel). They will also be asked to rate their visual qualities of their images on a 1-5 scale following each trial. | 0 | 24 | 1 | 24 | 11 | 24 |
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| Arthritis | Musculoskeletal and connective tissue disorders | Systematic Assessment |
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| Tinnitus | Ear and labyrinth disorders | Systematic Assessment |
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| Fall | Musculoskeletal and connective tissue disorders | Systematic Assessment |
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| Back/shoulder pain | Musculoskeletal and connective tissue disorders | Systematic Assessment |
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| Pain in lower extremities | Musculoskeletal and connective tissue disorders | Systematic Assessment |
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| Pain in upper extremities | Musculoskeletal and connective tissue disorders | Systematic Assessment |
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| Enlarged prostate | Reproductive system and breast disorders | Systematic Assessment |
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| Dizziness | Ear and labyrinth disorders | Systematic Assessment |
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Not provided
Not provided
Not provided
| Unknown or Not Reported |
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| Native Hawaiian or Other Pacific Islander |
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| Black or African American |
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| White |
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| More than one race |
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| Unknown or Not Reported |
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