Cognitive Remediation to Improve Mobility in Sedentary Seniors (CREM)
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|ClinicalTrials.gov Identifier: NCT02567227|
Recruitment Status : Recruiting
First Posted : October 2, 2015
Last Update Posted : April 22, 2019
|Condition or disease||Intervention/treatment||Phase|
|Mobility Limitation Motor Activity Difficulty Walking Cognitive Ability General||Other: Cognitive Remediation Other: Active Control||Not Applicable|
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.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||420 participants|
|Intervention Model:||Parallel Assignment|
|Official Title:||Cognitive Intervention to Improve Simple and Complex Walking|
|Study Start Date :||February 2016|
|Estimated Primary Completion Date :||August 2020|
|Estimated Study Completion Date :||August 2020|
Experimental: Cognitive Remediation
An individualized computerized cognitive remediation program.
Other: 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.
Active Comparator: Active control
Individualized computer based exposure and interactive health education classes.
Other: Active Control
Computer, multimedia and group based health education programs.
- Improvement in walking speed during single and dual-task conditions. [ Time Frame: 2 months ]Improvement in gait speed (centimeters/second) measured during normal pace walking and walking while talking conditions using an instrumented walkway (GAITRite® electronic walkway system).
- Improvement in Short physical performance battery (SPPB). [ Time Frame: 2 months ]Improvements 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. [ Time Frame: 2 months ]Change in stride length (cm) collected during normal walking and walking while talking conditions on an instrumented walkway.
- Gait variability. [ Time Frame: 2 months ]Change in gait variability, measured in standard deviation units, collected during normal walking and walking while talking on an instrumented walkway.
- Gait domains. [ Time Frame: 2 Months ]Changes 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.
- Substantial gait speed improvement. [ Time Frame: 2 Months ]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. [ Time Frame: 2 Months ]Improvements on the Flanker task, a measure of speed of processing, attention and inhibitory control. Scoring is based on accuracy and reaction time.
- Digit Symbol Substitution Test. [ Time Frame: 2 Months ]Improvement 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.
- Trail Making Test form A. [ Time Frame: 2 Months ]Improvement 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.
- Trail Making Test form B. [ Time Frame: 2 Months ]Improvement 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.
- Controlled Oral Word Association Test. [ Time Frame: 2 Months ]Improvement 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.
- Repeatable Battery for the Assessment of Neuropsychological Status. [ Time Frame: 2 Months ]Improvement 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. [ Time Frame: 2 Months ]Changes in prefrontal activation measure using functional near infra-red spectroscopy.
- Durability [ Time Frame: 6 months and 1 year ]Changes in gait speed during normal pace and walking while talking conditions measured at six months and one year.
- Stair climbing time. [ Time Frame: 2 Months ]Improvements in mobility and balance assessed during stair climbing, which provides a valid assessment tool for predicting disability.
- Disability Scale. [ Time Frame: 2 Months ]Changes in mobility assessed by 4 key activities of daily living tasks—bathing, dressing, walking, and transferring.
- The Geriatric Depression Scale (GDS). [ Time Frame: 2 months ]Changes in depressive symptoms assessed using the 30 item GDS, scores range from 0 (not depressed) to 30 (depressed).
- Rosenberg Self-Esteem Scale. [ Time Frame: 2 months ]Improvements in self-esteem assessed using a ten-item Likert-type scale (higher scores are better).
- Falls Efficacy Scale. [ Time Frame: 2 months ]Improvements in self-efficacy scores (range 0-100). Scored as the number of items for which subjects reported a 7 or greater in level of confidence (range 0-10).
- 12-Item Short Form Health Survey (SF-12). [ Time Frame: 2 months ]Change 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.
- Falls. [ Time Frame: 12 Months ]Presence and number of falls over 12 months from baseline.
- Number of participants with progression in cognitive impairment from normal cognitive function at baseline to Mild Cognitive Impairment (MCI) [ Time Frame: 2 Months ]Progression in cognitive impairment from normal cognitive function at baseline to MCI.
- Number of participants with progression in cognitive impairment from normal cognitive function at baseline to dementia [ Time Frame: 2 Months ]Progression in cognitive impairment from baseline normal cognitive function to dementia.
- Number of participants with progression in cognitive impairment from normal cognitive function at baseline to Motoric Cognitive Risk syndrome (MCR) [ Time Frame: 2 Months ]Progression in cognitive impairment from baseline normal cognitive function to MCR.
- Number of participants with progression in cognitive impairment from normal cognitive function at baseline to cognitively impaired [ Time Frame: 2 Months ]Progression in cognitive impairment from baseline normal cognitive function to cognitive impairment defined as presence of incident MCI, dementia, or MCR.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02567227
|Contact: Joe Verghese, MD||(718) email@example.com|
|Contact: Roee Holtzer, PhD||(718) firstname.lastname@example.org|
|United States, New York|
|Albert Einstein College of Medicine||Recruiting|
|Bronx, New York, United States, 10461|
|Contact: Emmeline Ayers, MPH 718-430-3835 email@example.com|
|Principal Investigator:||Joe Verghese, MD||Albert Einstein College of Medicine|
|Principal Investigator:||Roee Holtzer, PhD||Albert Einstein College of Medicine|