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| ID | Type | Description | Link |
|---|---|---|---|
| R01AG050448-01 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Institute on Aging (NIA) | NIH |
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The investigators propose to conduct a single-blind randomized clinical trial to test the efficacy of a computerized cognitive remediation intervention program on improving locomotion in sedentary seniors, a group at an especially high risk for disability. The hypothesis is that executive functions will respond to the cognitive remediation program and in turn enhance locomotion.
Emerging evidence indicates that Executive Functions play an important role in maintaining locomotion in aging and preventing mobility disabilities. However, use of cognitive training programs to improve executive functions as a strategy to increase mobility has not been explored. Exciting results from the preliminary study support the efficacy and feasibility of the cognitive remediation approach to improve locomotion in older adults.
The premise of this clinical trial is that disability among seniors is a potentially preventable chronic condition rather than an irreversible consequence of aging and disease. The investigators proposed novel approach to locomotion has the potential to shift treatment paradigms in the field of disability by introducing cognitive approaches to mobility that can be applied to prevention and rehabilitation in diverse settings. Through this 'proof of concept' secondary prevention trial the investigators will fill an important gap in knowledge for practicing evidence-based medicine and developing effective interventions for a major health outcome affecting a substantial proportion of the U.S. aging population.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Cognitive Remediation | Experimental | An individualized computerized cognitive remediation program. |
|
| Active control | Active Comparator | Individualized computer based exposure and interactive health education classes. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Cognitive Remediation | Other | This computerized program has successfully been used by seniors in different settings. It trains a number of cognitive processes including attention and Executive Function.The Cognitive Remediation (CREM) training is constructed based on the program's built in baseline cognitive evaluation. |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Walking Speed During Single and Dual-task Conditions. | Between group difference in change per arm of gait speed (centimeters/second) measured during normal pace walking and walking while talking conditions using an instrumented walkway (GAITRite® electronic walkway system). | Baseline and 2 months |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Short Physical Performance Battery (SPPB). | Between group difference in change per arm in mobility measured using the SPPB. The SPPB is comprised of balance, chair rise, and gait speed tests. A score is assigned in each of these three areas (0-4), and summed to obtain an overall summary score (0-12, higher better). | Baseline and 2 months |
| Measure | Description | Time Frame |
|---|---|---|
| The Geriatric Depression Scale (GDS). | Between group difference in change per arm in depressive symptoms assessed using the 30 item GDS, scores range from 0 (not depressed) to 30 (depressed). | Baseline and 2 months |
| Rosenberg Self-Esteem Scale. |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Joe Verghese, MD | Albert Einstein College of Medicine | Principal Investigator |
| Roee Holtzer, PhD | 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 |
|---|---|---|---|
| 20643703 | Result | Verghese J, Mahoney J, Ambrose AF, Wang C, Holtzer R. Effect of cognitive remediation on gait in sedentary seniors. J Gerontol A Biol Sci Med Sci. 2010 Dec;65(12):1338-43. doi: 10.1093/gerona/glq127. Epub 2010 Jul 19. | |
| 34522910 | Derived | Verghese J, Mahoney JR, Ayers E, Ambrose A, Wang C, Holtzer R. Computerised cognitive remediation to enhance mobility in older adults: a single-blind, single-centre, randomised trial. Lancet Healthy Longev. 2021 Sep;2(9):e571-e579. doi: 10.1016/s2666-7568(21)00173-2. Epub 2021 Sep 2. |
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| ID | Title | Description |
|---|---|---|
| FG000 | Cognitive Remediation | An individualized computerized cognitive remediation program. Cognitive Remediation: This computerized program has successfully been used by seniors in different settings. It trains a number of cognitive processes including attention and Executive Function.The Cognitive Remediation (CREM) training is constructed based on the program's built in baseline cognitive evaluation. |
| FG001 | Active Control | Individualized computer based exposure and interactive health education classes. Active Control: Computer, multimedia and group based health education programs. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 9 Weeks |
|
| |||||||||||||||||||||
| 6 Month |
| ||||||||||||||||||||||
| 12 Months |
|
Includes all participants who were randomized. Excludes participants diagnosed with dementia post-hoc (n=6 in Experimental; n=5 in Active Comparator)
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| ID | Title | Description |
|---|---|---|
| BG000 | Cognitive Remediation | An individualized computerized cognitive remediation program. Cognitive Remediation: This computerized program has successfully been used by seniors in different settings. It trains a number of cognitive processes including attention and Executive Function.The Cognitive Remediation (CREM) training is constructed based on the program's built in baseline cognitive evaluation. |
| Units | Counts |
|---|---|
| Participants |
|
| 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 Conditions. | Between group difference in change per arm of gait speed (centimeters/second) measured during normal pace walking and walking while talking conditions using an instrumented walkway (GAITRite® electronic walkway system). | Includes all participants who were randomized. Excludes participants diagnosed with dementia post-hoc (n=6 in Experimental; n=5 in Active Comparator). | Posted | Mean | Standard Error | centimeters per second | Baseline and 2 months |
|
12 months from intervention
Participants were asked if they had any falls or changes in their health at bimonthly phone calls between study visits
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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 | Cognitive Remediation | An individualized computerized cognitive remediation program. Cognitive Remediation: This computerized program has successfully been used by seniors in different settings. It trains a number of cognitive processes including attention and Executive Function.The Cognitive Remediation (CREM) training is constructed based on the program's built in baseline cognitive evaluation. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Chest pain | Cardiac disorders | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Fall | Musculoskeletal and connective tissue disorders | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Joe Verghese | Albert Einstein College of Medicine | 718-430-3877 | joe.verghese@einsteinmed.org |
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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 | Oct 16, 2017 | Feb 3, 2021 | Prot_SAP_000.pdf |
| ICF | No | No | Yes | Informed Consent Form | Feb 27, 2020 | Feb 3, 2021 | ICF_001.pdf |
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| ID | Term |
|---|---|
| D051346 | Mobility Limitation |
| D009043 | Motor Activity |
| ID | Term |
|---|---|
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D001519 | Behavior |
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| ID | Term |
|---|---|
| D000072466 | Cognitive Remediation |
| ID | Term |
|---|---|
| D001521 | Behavior Therapy |
| D011613 | Psychotherapy |
| D004191 | Behavioral Disciplines and Activities |
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|
| Active Control | Other | Computer, multimedia and group based health education programs. |
|
| Stride Length. | Between group difference in change per arm in stride length (cm) collected during normal walking and walking while talking conditions on an instrumented walkway. | Baseline and 2 months |
| Gait Variability. | Between group difference in change per arm in gait stride length variability, measured in standard deviation units, collected during normal walking and walking while talking on an instrumented walkway. Gait variability is defined as differences in length from one stride to the next. | Baseline and 2 months |
| Variability in Gait Domains | Between group difference in change per arm in gait domains (summary measures reported as standard deviation units) derived from factor analysis of quantitative gait variables collected on an instrumented walkway during normal walking and walking while talking. Based on previous findings of gait patterns, pace, rhythm and variation factors are defined (using z-scores based on mean and standard deviation at baseline). Higher values are indicative of better performance for pace and rhythm factors and indicative of worse performance for variation factors. | Baseline and 2 Months |
| Number of Participants With Substantial Gait Speed Change. | Substantial gait speed improvement is defined as change of ≥1 standard deviation units from baseline performance in gait speed measured during normal walking and walking while talking conditions. | Baseline and 2 Months |
| Flanker Task. | Between group difference in change per arm on the Flanker task, a measure of speed of processing, attention and inhibitory control. Scoring is based on reaction time in milliseconds (ms) and calculated as the difference in reaction time that it takes a person, on average, to respond to an incongruent minus congruent stimulus. Lower values reflect better outcome. | Baseline and 2 Months |
| Digit Symbol Substitution Test. | Between group difference in change per arm on the Digit Symbol Substitution Test (a subtest of the Wechsler Adult Intelligence Scale - Revised), a measure of attention, transcription and speed of processing. Scoring is based on the total number of correct responses generated during a 90-sec time interval. Scores range from 0-133 with higher scores indicating better performance. | Baseline and 2 Months |
| Trail Making Test Form A. | Between group difference in change per arm on Trail Making Test form A, a timed measure of attention. Scoring is based on the time required to complete the task and on accuracy. Scores range from 0-300 seconds with longer time indicating worse performance. Scores were log transformed prior to analysis. | Baseline and 2 Months |
| Trail Making Test Form B. | Between group difference in change per arm on Trail Making Test form B, a timed measure of attention, set shifting and processing speed. Scoring is based on the time required to complete the task and on accuracy. Scores range from 0-300 seconds with longer time indicating worse performance. Scores were log transformed prior to analysis. | Baseline and 2 Months |
| Controlled Oral Word Association Test. | Between group difference in change per arm on the Controlled Oral Word Association Test, a verbal fluency test that measures word generation performance under specified timed phonemic and semantic conditions. Performance measured by the total number of correct words as well as the number of errors. Scores range from 25-41 seconds with higher scores indicating better performance. | Baseline and 2 Months |
| Repeatable Battery for the Assessment of Neuropsychological Status. | Between group difference in change on the Repeatable Battery for the Assessment of Neuropsychological Status, a relatively brief battery that assesses overall level of cognitive function This battery consists of 10 neurocognitive tests measuring memory (immediate and delayed), attention, language, visuospatial abilities and executive functions. Performance is converted to standardized scores derived from a normative sample. | Baseline and 2 Months |
| Neuroplasticity. | Changes in prefrontal activation measure using functional near infra-red spectroscopy. | Baseline and 2 Months |
| Durability | Between group difference in change per arm in gait speed during normal pace and walking while talking conditions measured at six months. | Baseline and 6 months |
| Stair Climbing Time. | Between group difference in change per arm in mobility and balance assessed during stair climbing, which provides a valid assessment tool for predicting disability. Scores are measured as time in seconds to climb 3 stairs with longer time indicating worse performance. Scores were log transformed prior to analysis. | Baseline and 2 Months |
| Disability Scale. | Between group difference in change per arm in mobility assessed by activities of daily living tasks on the Activities of Daily Living-Prevention Instrument. Scores range from 0-45 and higher scores indicate poorer function. | Baseline and 2 Months |
Between group difference in change per arm in self-esteem assessed using a ten-item Likert-type scale (higher scores are better).
| Baseline and 2 months |
| Falls Efficacy Scale. | Between group difference in change per arm in self-efficacy scores (range 0-100). Higher scores indicate less confidence. | Baseline and 2 months |
| 12-Item Short Form Health Survey (SF-12). | Between group difference in change per arm in perceptions of health and quality of life in domains that include social, physical, emotional and mental functions. The SF-12 has 12 items; two component scores capturing perceptions of mental and physical function can be derived. The Physical Component Summary (PCS-12) and Mental Component Summary (MCS-12) scores are calculated using 12 questions with a range of 0-100 (zero indicating the poorest level of health measured and 100 indicating the highest). | Baseline and 2 months |
| Falls. | Presence and number of falls over 12 months from baseline. | Baseline and 12 Months |
| Number of Participants With Progression in Cognitive Impairment From Normal Cognitive Function at Baseline to Mild Cognitive Impairment (MCI) | Progression in cognitive impairment from normal cognitive function at baseline to MCI. | Baseline and 2 Months |
| Number of Participants With Progression in Cognitive Impairment From Normal Cognitive Function at Baseline to Dementia | Progression in cognitive impairment from baseline normal cognitive function to dementia. | Baseline and 2 Months |
| Number of Participants With Progression in Cognitive Impairment From Normal Cognitive Function at Baseline to Motoric Cognitive Risk Syndrome (MCR) | Progression in cognitive impairment from baseline normal cognitive function to MCR. | Baseline and 2 Months |
| Number of Participants With Progression in Cognitive Impairment From Normal Cognitive Function at Baseline to Cognitively Impaired | Progression in cognitive impairment from baseline normal cognitive function to cognitive impairment defined as presence of incident MCI, dementia, or MCR. | Baseline and 2 Months |
| 27813452 | Derived | Verghese J, Ayers E, Mahoney JR, Ambrose A, Wang C, Holtzer R. Cognitive remediation to enhance mobility in older adults: the CREM study. Neurodegener Dis Manag. 2016 Dec;6(6):457-466. doi: 10.2217/nmt-2016-0034. Epub 2016 Nov 4. |
| Study suspended due to COVID-19 pandemic |
|
| NOT COMPLETED |
|
|
| NOT COMPLETED |
|
|
| BG001 | Active Control | Individualized computer based exposure and interactive health education classes. Active Control: Computer, multimedia and group based health education programs. |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Gait Speed, cm/s | Gait speed during normal walking. | Mean | Standard Deviation | centimeters per second |
|
| OG001 | Active Control | Individualized computer based exposure and interactive health education classes. Active Control: Computer, multimedia and group based health education programs. |
|
|
|
| Secondary | Change in Short Physical Performance Battery (SPPB). | Between group difference in change per arm in mobility measured using the SPPB. The SPPB is comprised of balance, chair rise, and gait speed tests. A score is assigned in each of these three areas (0-4), and summed to obtain an overall summary score (0-12, higher better). | Includes all participants who were randomized. Excludes participants diagnosed with dementia post-hoc (n=6 in Experimental; n=5 in Active Comparator) | Posted | Mean | Standard Error | score on a scale | Baseline and 2 months |
|
|
|
|
| Secondary | Stride Length. | Between group difference in change per arm in stride length (cm) collected during normal walking and walking while talking conditions on an instrumented walkway. | Includes all participants who were randomized. Excludes participants diagnosed with dementia post-hoc (n=6 Experimental; n=5 Active Comparator). | Posted | Mean | Standard Error | centimeters | Baseline and 2 months |
|
|
|
|
| Secondary | Gait Variability. | Between group difference in change per arm in gait stride length variability, measured in standard deviation units, collected during normal walking and walking while talking on an instrumented walkway. Gait variability is defined as differences in length from one stride to the next. | Includes all participants who were randomized. Excludes participants diagnosed with dementia post-hoc (n=6 Experimental; n=5 Active Comparator). | Posted | Mean | Standard Error | standard deviation | Baseline and 2 months |
|
|
|
|
| Secondary | Variability in Gait Domains | Between group difference in change per arm in gait domains (summary measures reported as standard deviation units) derived from factor analysis of quantitative gait variables collected on an instrumented walkway during normal walking and walking while talking. Based on previous findings of gait patterns, pace, rhythm and variation factors are defined (using z-scores based on mean and standard deviation at baseline). Higher values are indicative of better performance for pace and rhythm factors and indicative of worse performance for variation factors. | Includes all participants who were randomized. Excludes participants diagnosed with dementia post-hoc (n=6 Experimental; n=5 Active Comparator). | Posted | Mean | Standard Error | standard deviation | Baseline and 2 Months |
|
|
|
|
| Secondary | Number of Participants With Substantial Gait Speed Change. | Substantial gait speed improvement is defined as change of ≥1 standard deviation units from baseline performance in gait speed measured during normal walking and walking while talking conditions. | Includes all participants who were randomized. Excludes participants diagnosed with dementia post-hoc (n=6 Experimental; n=5 Active Comparator) and participants who did not complete the 2 month follow-up assessment (n=34 Experimental; n=24 Active Comparator). | Posted | Count of Participants | Participants | Baseline and 2 Months |
|
|
|
|
| Secondary | Flanker Task. | Between group difference in change per arm on the Flanker task, a measure of speed of processing, attention and inhibitory control. Scoring is based on reaction time in milliseconds (ms) and calculated as the difference in reaction time that it takes a person, on average, to respond to an incongruent minus congruent stimulus. Lower values reflect better outcome. | Includes all participants who were randomized. Excludes participants diagnosed with dementia post-hoc (n=6 Experimental; n=5 Active Comparator) and 86 participants (n=43 Experimental; n=43 Active Comparator) with performance inaccuracy >75%. | Posted | Mean | Standard Error | milliseconds | Baseline and 2 Months |
|
|
|
|
| Secondary | Digit Symbol Substitution Test. | Between group difference in change per arm on the Digit Symbol Substitution Test (a subtest of the Wechsler Adult Intelligence Scale - Revised), a measure of attention, transcription and speed of processing. Scoring is based on the total number of correct responses generated during a 90-sec time interval. Scores range from 0-133 with higher scores indicating better performance. | Includes all participants who were randomized. Excludes participants diagnosed with dementia post-hoc (n=6 Experimental; n=5 Active Comparator). | Posted | Mean | Standard Error | score on a scale | Baseline and 2 Months |
|
|
|
|
| Secondary | Trail Making Test Form A. | Between group difference in change per arm on Trail Making Test form A, a timed measure of attention. Scoring is based on the time required to complete the task and on accuracy. Scores range from 0-300 seconds with longer time indicating worse performance. Scores were log transformed prior to analysis. | Includes all participants who were randomized. Excludes participants diagnosed with dementia post-hoc (n=6 Experimental; n=5 Active Comparator). | Posted | Mean | Standard Error | log (scores on a scale) | Baseline and 2 Months |
|
|
|
|
| Secondary | Trail Making Test Form B. | Between group difference in change per arm on Trail Making Test form B, a timed measure of attention, set shifting and processing speed. Scoring is based on the time required to complete the task and on accuracy. Scores range from 0-300 seconds with longer time indicating worse performance. Scores were log transformed prior to analysis. | Includes all participants who were randomized. Excludes participants diagnosed with dementia post-hoc (n=6 Experimental; n=5 Active Comparator). | Posted | Mean | Standard Error | log (scores on a scale) | Baseline and 2 Months |
|
|
|
|
| Secondary | Controlled Oral Word Association Test. | Between group difference in change per arm on the Controlled Oral Word Association Test, a verbal fluency test that measures word generation performance under specified timed phonemic and semantic conditions. Performance measured by the total number of correct words as well as the number of errors. Scores range from 25-41 seconds with higher scores indicating better performance. | Includes all participants who were randomized. Excludes participants diagnosed with dementia post-hoc (n=6 Experimental; n=5 Active Comparator). | Posted | Mean | Standard Error | score on a scale | Baseline and 2 Months |
|
|
|
|
| Secondary | Repeatable Battery for the Assessment of Neuropsychological Status. | Between group difference in change on the Repeatable Battery for the Assessment of Neuropsychological Status, a relatively brief battery that assesses overall level of cognitive function This battery consists of 10 neurocognitive tests measuring memory (immediate and delayed), attention, language, visuospatial abilities and executive functions. Performance is converted to standardized scores derived from a normative sample. | No outcome measure data was collected for this outcome. | Posted | Baseline and 2 Months |
|
|
| Secondary | Neuroplasticity. | Changes in prefrontal activation measure using functional near infra-red spectroscopy. | No outcome measure data was collected for this outcome. | Posted | Baseline and 2 Months |
|
|
| Secondary | Durability | Between group difference in change per arm in gait speed during normal pace and walking while talking conditions measured at six months. | Includes all participants who were randomized. Excludes participants diagnosed with dementia post-hoc (n=6 Experimental; n=5 Active Comparator). | Posted | Mean | Standard Error | centimeters per second | Baseline and 6 months |
|
|
|
|
| Secondary | Stair Climbing Time. | Between group difference in change per arm in mobility and balance assessed during stair climbing, which provides a valid assessment tool for predicting disability. Scores are measured as time in seconds to climb 3 stairs with longer time indicating worse performance. Scores were log transformed prior to analysis. | Includes all participants who were randomized. Excludes participants diagnosed with dementia post-hoc (n=6 Experimental; n=5 Active Comparator). | Posted | Mean | Standard Error | log (seconds) | Baseline and 2 Months |
|
|
|
|
| Secondary | Disability Scale. | Between group difference in change per arm in mobility assessed by activities of daily living tasks on the Activities of Daily Living-Prevention Instrument. Scores range from 0-45 and higher scores indicate poorer function. | Includes all participants who were randomized. Excludes participants diagnosed with dementia post-hoc (n=6 Experimental; n=5 Active Comparator). | Posted | Mean | Standard Error | score on a scale | Baseline and 2 Months |
|
|
|
|
| Other Pre-specified | The Geriatric Depression Scale (GDS). | Between group difference in change per arm in depressive symptoms assessed using the 30 item GDS, scores range from 0 (not depressed) to 30 (depressed). | Includes all participants who were randomized. Excludes participants diagnosed with dementia post-hoc (n=6 Experimental; n=5 Active Comparator). | Posted | Mean | Standard Error | score on a scale | Baseline and 2 months |
|
|
|
|
| Other Pre-specified | Rosenberg Self-Esteem Scale. | Between group difference in change per arm in self-esteem assessed using a ten-item Likert-type scale (higher scores are better). | Only baseline data was collected on this outcome measure, therefore no data was analyzed. | Posted | Baseline and 2 months |
|
|
| Other Pre-specified | Falls Efficacy Scale. | Between group difference in change per arm in self-efficacy scores (range 0-100). Higher scores indicate less confidence. | Includes all participants who were randomized. Excludes participants diagnosed with dementia post-hoc (n=6 Experimental; n=5 Active Comparator). | Posted | Mean | Standard Error | score on a scale | Baseline and 2 months |
|
|
|
|
| Other Pre-specified | 12-Item Short Form Health Survey (SF-12). | Between group difference in change per arm in perceptions of health and quality of life in domains that include social, physical, emotional and mental functions. The SF-12 has 12 items; two component scores capturing perceptions of mental and physical function can be derived. The Physical Component Summary (PCS-12) and Mental Component Summary (MCS-12) scores are calculated using 12 questions with a range of 0-100 (zero indicating the poorest level of health measured and 100 indicating the highest). | Includes all participants who were randomized. Excludes participants diagnosed with dementia post-hoc (n=6 Experimental; n=5 Active Comparator). | Posted | Mean | Standard Error | score on a scale | Baseline and 2 months |
|
|
|
|
| Other Pre-specified | Falls. | Presence and number of falls over 12 months from baseline. | Not Posted | Baseline and 12 Months | Participants |
| Other Pre-specified | Number of Participants With Progression in Cognitive Impairment From Normal Cognitive Function at Baseline to Mild Cognitive Impairment (MCI) | Progression in cognitive impairment from normal cognitive function at baseline to MCI. | Not Posted | Baseline and 2 Months | Participants |
| Other Pre-specified | Number of Participants With Progression in Cognitive Impairment From Normal Cognitive Function at Baseline to Dementia | Progression in cognitive impairment from baseline normal cognitive function to dementia. | Not Posted | Baseline and 2 Months | Participants |
| Other Pre-specified | Number of Participants With Progression in Cognitive Impairment From Normal Cognitive Function at Baseline to Motoric Cognitive Risk Syndrome (MCR) | Progression in cognitive impairment from baseline normal cognitive function to MCR. | Not Posted | Baseline and 2 Months | Participants |
| Other Pre-specified | Number of Participants With Progression in Cognitive Impairment From Normal Cognitive Function at Baseline to Cognitively Impaired | Progression in cognitive impairment from baseline normal cognitive function to cognitive impairment defined as presence of incident MCI, dementia, or MCR. | Not Posted | Baseline and 2 Months | Participants |
| 2 |
| 192 |
| 5 |
| 192 |
| 49 |
| 192 |
| EG001 | Active Control | Individualized computer based exposure and interactive health education classes. Active Control: Computer, multimedia and group based health education programs. | 2 | 191 | 1 | 191 | 34 | 191 |
| High blood pressure | Cardiac disorders | Systematic Assessment |
|
| Leg pain | Musculoskeletal and connective tissue disorders | Systematic Assessment |
|
| Fall | Musculoskeletal and connective tissue disorders | Systematic Assessment |
|
| Leg pain | Musculoskeletal and connective tissue disorders | Systematic Assessment |
|
Not provided
Not provided
Not provided
| Unadjusted linear mixed effects models were used to compare changes in stride length during normal walking pre and post intervention. | Mean Difference (Net) | -1.95 | Standard Error of the Mean | 1.04 | 2-Sided | Estimates with standard errors are from linear mixed effect models. | Superiority |
| Linear mixed effects model adjusted for age, sex, education (school years), comorbidities score (0-10), pain, Duke score (cardiac fitness), and cognitive status (MCI or cognitively normal) were used to compare changes in stride length variability during walking while talking pre and post intervention. | Mean Difference (Net) | -0.44 | Standard Error of the Mean | 0.36 | 2-Sided | 95 | -1.16 | 0.27 | Estimates with standard errors are from linear mixed effect models adjusted for age, sex, education years, comorbidities, pain, cardiac fitness, and cognitive status. | Superiority |
| Normal walking variation |
|
| Walking while talking pace |
|
| Walking while talking rhythm |
|
| Walking while talking variation |
|
| Linear mixed effects model adjusted for age, sex, education (school years), comorbidities score (0-10), pain, Duke score (cardiac fitness), and cognitive status (MCI or cognitively normal) were used to compare changes in the rhythm domain during normal pace walking pre and post intervention. | Mean Difference (Net) | 0.10 | 2-Sided | 95 | -0.20 | 0.41 | Estimates with standard errors are from linear mixed effect models adjusted for age, sex, education years, comorbidities, pain, cardiac fitness, and cognitive status. | Superiority |
| Linear mixed effects model adjusted for age, sex, education (school years), comorbidities score (0-10), pain, Duke score (cardiac fitness), and cognitive status (MCI or cognitively normal) were used to compare changes in the variation domain during normal pace walking pre and post intervention. | Mean Difference (Net) | -0.11 | 2-Sided | 95 | -0.53 | 0.32 | Estimates with standard errors are from linear mixed effect models adjusted for age, sex, education years, comorbidities, pain, cardiac fitness, and cognitive status. | Superiority |
| Linear mixed effects model adjusted for age, sex, education (school years), comorbidities score (0-10), pain, Duke score (cardiac fitness), and cognitive status (MCI or cognitively normal) were used to compare changes in the pace domain during walking while talking pre and post intervention. | Mean Difference (Net) | 0.14 | 2-Sided | 95 | -0.27 | 0.56 | Estimates with standard errors are from linear mixed effect models adjusted for age, sex, education years, comorbidities, pain, cardiac fitness, and cognitive status. | Superiority |
| Linear mixed effects model adjusted for age, sex, education (school years), comorbidities score (0-10), pain, Duke score (cardiac fitness), and cognitive status (MCI or cognitively normal) were used to compare changes in the rhythm domain during walking while talking pre and post intervention. | Mean Difference (Net) | -0.02 | 2-Sided | 95 | -0.48 | 0.45 | Estimates with standard errors are from linear mixed effect models adjusted for age, sex, education years, comorbidities, pain, cardiac fitness, and cognitive status. | Superiority |
| Linear mixed effects model adjusted for age, sex, education (school years), comorbidities score (0-10), pain, Duke score (cardiac fitness), and cognitive status (MCI or cognitively normal) were used to compare changes in the variation domain during walking while talking pre and post intervention. | Mean Difference (Net) | -0.02 | 2-Sided | 95 | -0.40 | 0.35 | Estimates with standard errors are from linear mixed effect models adjusted for age, sex, education years, comorbidities, pain, cardiac fitness, and cognitive status. | Superiority |
| Substantial walking while talking speed improvement |
|
Logistic model for treatment effect on substantial improvement in walking while talking velocity adjusted for age, sex, education (school years), comorbidities score (0-10), pain, Duke score (cardiac fitness), and cognitive status (MCI or cognitively normal). |
| Odds Ratio (OR) |
| 0.961 |
| 2-Sided |
| 95 |
| 0.516 |
| 1.789 |
| Superiority |
| Linear mixed effects model adjusted for age, sex, education (school years), comorbidities score (0-10), pain, Duke score (cardiac fitness), and cognitive status (MCI or cognitively normal) were used to compare changes in gait speed during walking while talking pre and 6 months post intervention. | Mean Difference (Net) | 1.40 | Standard Error of the Mean | 1.79 | 2-Sided | 95 | -2.12 | 4.91 | Estimates with standard errors are from linear mixed effect models adjusted for age, sex, education years, comorbidities, pain, cardiac fitness, and cognitive status. | Superiority |
| Linear mixed effects model adjusted for age, sex, education (school years), comorbidities score (0-10), pain, Duke score (cardiac fitness), and cognitive status (MCI or cognitively normal) were used to compare changes in the mental health score of the SF-12 pre and post intervention. | Mean Difference (Final Values) | 0.41 | Standard Error of the Mean | 0.73 | 2-Sided | 95 | -1.04 | 1.85 | Estimates with standard errors are from linear mixed effect models adjusted for age, sex, education years, comorbidities, pain, cardiac fitness, and cognitive status. | Superiority |