Back to resultsCognitive Remediation to Improve Mobility in Sedentary Seniors (CREM)
Primary Purpose
Mobility Limitation, Motor Activity, Difficulty Walking
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Cognitive Remediation
Active Control
Sponsored by
About this trial
This is an interventional treatment trial for Mobility Limitation
Eligibility Criteria
Inclusion Criteria:
- Adults aged 70 and older, residing in the community.
- Plan to be in area for next year.
- Able to speak English at a level sufficient to undergo our cognitive assessment battery.
- Ambulatory. Subjects are classified as 'non-ambulatory' if they are unable to leave the confines of their home and attend a clinic visit.
- Gait velocity ≤1 m/s.
- Short Physical Performance Battery score ≤9.
Exclusion Criteria:
- Presence of dementia identified by any one of the following: Telephone based Memory Impairment Screen score (T-MIS) of <5, Alzheimer's Disease 8 (AD8) ≥ 2. Or dementia diagnosed by baseline cognitive assessment.
- Serious chronic or acute illness such as cancer (late stage, metastatic, or on active treatment), chronic pulmonary disease on ventilator or continuous oxygen therapy or active liver disease.
- Mobility limitations solely due to musculoskeletal limitation or pain (e.g., severe osteoarthritis) that prevent subjects from completing mobility tests. Presence of arthritis will not be used to exclude subjects if they can complete the mobility tasks.
- Any medical condition or chronic medication use (e.g., neuroleptics) that will compromise safety or affect cognitive functioning or terminal illness with life expectancy less than 12 months.
- Presence of progressive, degenerative neurologic disease (e.g., Parkinson's disease or ALS).
- Hospitalized in the past 6 months for severe illness or surgery that specifically affects mobility (e.g. hip or knee replacement) and that prevent subjects from completing mobility tests or plans for surgery affecting mobility in the next 6 months.
- Severe auditory or visual loss.
- Active psychoses or psychiatric symptoms (such as agitation) noted during the clinic visit that will prevent completion of study protocols.
- Living in nursing home.
- Participation in other intervention trial or observational studies. -
Sites / Locations
- Albert Einstein College of Medicine
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Cognitive Remediation
Active control
Arm Description
An individualized computerized cognitive remediation program.
Individualized computer based exposure and interactive health education classes.
Outcomes
Primary Outcome Measures
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).
Secondary Outcome Measures
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).
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
Neuroplasticity.
Changes in prefrontal activation measure using functional near infra-red spectroscopy.
Durability
Between group difference in change per arm in gait speed during normal pace and walking while talking conditions measured at six 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.
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.
Full Information
NCT ID
NCT02567227
First Posted
August 17, 2015
Last Updated
May 12, 2021
Sponsor
Albert Einstein College of Medicine
Collaborators
National Institute on Aging (NIA)
1. Study Identification
Unique Protocol Identification Number
NCT02567227
Brief Title
Cognitive Remediation to Improve Mobility in Sedentary Seniors
Acronym
CREM
Official Title
Cognitive Intervention to Improve Simple and Complex Walking
Study Type
Interventional
2. Study Status
Record Verification Date
May 2021
Overall Recruitment Status
Completed
Study Start Date
March 2016 (Actual)
Primary Completion Date
June 2020 (Actual)
Study Completion Date
August 2020 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Albert Einstein College of Medicine
Collaborators
National Institute on Aging (NIA)
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
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.
Detailed Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Mobility Limitation, Motor Activity, Difficulty Walking, Cognitive Ability General
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
383 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Cognitive Remediation
Arm Type
Experimental
Arm Description
An individualized computerized cognitive remediation program.
Arm Title
Active control
Arm Type
Active Comparator
Arm Description
Individualized computer based exposure and interactive health education classes.
Intervention Type
Other
Intervention Name(s)
Cognitive Remediation
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
Active Control
Intervention Description
Computer, multimedia and group based health education programs.
Primary Outcome Measure Information:
Title
Change in Walking Speed During Single and Dual-task Conditions.
Description
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).
Time Frame
Baseline and 2 months
Secondary Outcome Measure Information:
Title
Change in Short Physical Performance Battery (SPPB).
Description
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).
Time Frame
Baseline and 2 months
Title
Stride Length.
Description
Between group difference in change per arm in stride length (cm) collected during normal walking and walking while talking conditions on an instrumented walkway.
Time Frame
Baseline and 2 months
Title
Gait Variability.
Description
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.
Time Frame
Baseline and 2 months
Title
Gait Domains.
Description
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.
Time Frame
Baseline and 2 Months
Title
Number of Participants With Substantial Gait Speed Change.
Description
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.
Time Frame
Baseline and 2 Months
Title
Flanker Task.
Description
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.
Time Frame
Baseline and 2 Months
Title
Digit Symbol Substitution Test.
Description
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.
Time Frame
Baseline and 2 Months
Title
Trail Making Test Form A.
Description
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.
Time Frame
Baseline and 2 Months
Title
Trail Making Test Form B.
Description
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.
Time Frame
Baseline and 2 Months
Title
Controlled Oral Word Association Test.
Description
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.
Time Frame
Baseline and 2 Months
Title
Repeatable Battery for the Assessment of Neuropsychological Status.
Description
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.
Time Frame
Baseline and 2 Months
Title
Neuroplasticity.
Description
Changes in prefrontal activation measure using functional near infra-red spectroscopy.
Time Frame
Baseline and 2 Months
Title
Durability
Description
Between group difference in change per arm in gait speed during normal pace and walking while talking conditions measured at six months.
Time Frame
Baseline and 6 months
Title
Stair Climbing Time.
Description
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.
Time Frame
Baseline and 2 Months
Title
Disability Scale.
Description
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.
Time Frame
Baseline and 2 Months
Other Pre-specified Outcome Measures:
Title
The Geriatric Depression Scale (GDS).
Description
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).
Time Frame
Baseline and 2 months
Title
Rosenberg Self-Esteem Scale.
Description
Between group difference in change per arm in self-esteem assessed using a ten-item Likert-type scale (higher scores are better).
Time Frame
Baseline and 2 months
Title
Falls Efficacy Scale.
Description
Between group difference in change per arm in self-efficacy scores (range 0-100). Higher scores indicate less confidence.
Time Frame
Baseline and 2 months
Title
12-Item Short Form Health Survey (SF-12).
Description
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).
Time Frame
Baseline and 2 months
Title
Falls.
Description
Presence and number of falls over 12 months from baseline.
Time Frame
Baseline and 12 Months
Title
Number of Participants With Progression in Cognitive Impairment From Normal Cognitive Function at Baseline to Mild Cognitive Impairment (MCI)
Description
Progression in cognitive impairment from normal cognitive function at baseline to MCI.
Time Frame
Baseline and 2 Months
Title
Number of Participants With Progression in Cognitive Impairment From Normal Cognitive Function at Baseline to Dementia
Description
Progression in cognitive impairment from baseline normal cognitive function to dementia.
Time Frame
Baseline and 2 Months
Title
Number of Participants With Progression in Cognitive Impairment From Normal Cognitive Function at Baseline to Motoric Cognitive Risk Syndrome (MCR)
Description
Progression in cognitive impairment from baseline normal cognitive function to MCR.
Time Frame
Baseline and 2 Months
Title
Number of Participants With Progression in Cognitive Impairment From Normal Cognitive Function at Baseline to Cognitively Impaired
Description
Progression in cognitive impairment from baseline normal cognitive function to cognitive impairment defined as presence of incident MCI, dementia, or MCR.
Time Frame
Baseline and 2 Months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Adults aged 70 and older, residing in the community.
Plan to be in area for next year.
Able to speak English at a level sufficient to undergo our cognitive assessment battery.
Ambulatory. Subjects are classified as 'non-ambulatory' if they are unable to leave the confines of their home and attend a clinic visit.
Gait velocity ≤1 m/s.
Short Physical Performance Battery score ≤9.
Exclusion Criteria:
Presence of dementia identified by any one of the following: Telephone based Memory Impairment Screen score (T-MIS) of <5, Alzheimer's Disease 8 (AD8) ≥ 2. Or dementia diagnosed by baseline cognitive assessment.
Serious chronic or acute illness such as cancer (late stage, metastatic, or on active treatment), chronic pulmonary disease on ventilator or continuous oxygen therapy or active liver disease.
Mobility limitations solely due to musculoskeletal limitation or pain (e.g., severe osteoarthritis) that prevent subjects from completing mobility tests. Presence of arthritis will not be used to exclude subjects if they can complete the mobility tasks.
Any medical condition or chronic medication use (e.g., neuroleptics) that will compromise safety or affect cognitive functioning or terminal illness with life expectancy less than 12 months.
Presence of progressive, degenerative neurologic disease (e.g., Parkinson's disease or ALS).
Hospitalized in the past 6 months for severe illness or surgery that specifically affects mobility (e.g. hip or knee replacement) and that prevent subjects from completing mobility tests or plans for surgery affecting mobility in the next 6 months.
Severe auditory or visual loss.
Active psychoses or psychiatric symptoms (such as agitation) noted during the clinic visit that will prevent completion of study protocols.
Living in nursing home.
Participation in other intervention trial or observational studies. -
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Joe Verghese, MD
Organizational Affiliation
Albert Einstein College of Medicine
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Roee Holtzer, PhD
Organizational Affiliation
Albert Einstein College of Medicine
Official's Role
Principal Investigator
Facility Information:
Facility Name
Albert Einstein College of Medicine
City
Bronx
State/Province
New York
ZIP/Postal Code
10461
Country
United States
12. IPD Sharing Statement
Citations:
PubMed Identifier
20643703
Citation
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.
Results Reference
result
PubMed Identifier
34522910
Citation
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.
Results Reference
derived
PubMed Identifier
27813452
Citation
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.
Results Reference
derived
Learn more about this trial
Cognitive Remediation to Improve Mobility in Sedentary Seniors
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