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Cognitive Remediation to Improve Mobility in Sedentary Seniors (CREM)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02567227
Recruitment Status : Recruiting
First Posted : October 2, 2015
Last Update Posted : April 22, 2019
Sponsor:
Collaborator:
National Institute on Aging (NIA)
Information provided by (Responsible Party):
Joe Verghese, Albert Einstein College of Medicine

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.

Condition or disease Intervention/treatment Phase
Mobility Limitation Motor Activity Difficulty Walking Cognitive Ability General Other: Cognitive Remediation Other: Active Control Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 420 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
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

Arm Intervention/treatment
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.




Primary Outcome Measures :
  1. 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).


Secondary Outcome Measures :
  1. 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).

  2. Stride length. [ Time Frame: 2 months ]
    Change in stride length (cm) collected during normal walking and walking while talking conditions on an instrumented walkway.

  3. 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.

  4. 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.

  5. 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.

  6. 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.

  7. 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.

  8. 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.

  9. 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.

  10. 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.

  11. 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.

  12. Neuroplasticity. [ Time Frame: 2 Months ]
    Changes in prefrontal activation measure using functional near infra-red spectroscopy.

  13. 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.

  14. 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.

  15. Disability Scale. [ Time Frame: 2 Months ]
    Changes in mobility assessed by 4 key activities of daily living tasks—bathing, dressing, walking, and transferring.


Other Outcome Measures:
  1. 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).

  2. Rosenberg Self-Esteem Scale. [ Time Frame: 2 months ]
    Improvements in self-esteem assessed using a ten-item Likert-type scale (higher scores are better).

  3. 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).

  4. 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.

  5. Falls. [ Time Frame: 12 Months ]
    Presence and number of falls over 12 months from baseline.

  6. 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.

  7. 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.

  8. 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.

  9. 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.



Information from the National Library of Medicine

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Ages Eligible for Study:   70 Years and older   (Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  1. Adults aged 70 and older, residing in the community.
  2. Plan to be in area for next year.
  3. Able to speak English at a level sufficient to undergo our cognitive assessment battery.
  4. Ambulatory. Subjects are classified as 'non-ambulatory' if they are unable to leave the confines of their home and attend a clinic visit.
  5. Gait velocity ≤1 m/s.
  6. Short Physical Performance Battery score ≤9.

Exclusion Criteria:

  1. 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.
  2. 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.
  3. 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.
  4. 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.
  5. Presence of progressive, degenerative neurologic disease (e.g., Parkinson's disease or ALS).
  6. 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.
  7. Severe auditory or visual loss.
  8. Active psychoses or psychiatric symptoms (such as agitation) noted during the clinic visit that will prevent completion of study protocols.
  9. Living in nursing home.
  10. Participation in other intervention trial or observational studies. -

Information from the National Library of Medicine

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


Contacts
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Contact: Joe Verghese, MD (718) 430-3877 joe.verghese@einstein.yu.edu
Contact: Roee Holtzer, PhD (718) 430-3962 roee.holtzer@einstein.yu.edu

Locations
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United States, New York
Albert Einstein College of Medicine Recruiting
Bronx, New York, United States, 10461
Contact: Emmeline Ayers, MPH    718-430-3835    emmeline.ayers@einstein.yu.edu   
Sponsors and Collaborators
Albert Einstein College of Medicine
National Institute on Aging (NIA)
Investigators
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Principal Investigator: Joe Verghese, MD Albert Einstein College of Medicine
Principal Investigator: Roee Holtzer, PhD Albert Einstein College of Medicine

Publications of Results:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Joe Verghese, Professor, Albert Einstein College of Medicine
ClinicalTrials.gov Identifier: NCT02567227    
Other Study ID Numbers: 2015-4752
R01AG050448-01 ( U.S. NIH Grant/Contract )
First Posted: October 2, 2015    Key Record Dates
Last Update Posted: April 22, 2019
Last Verified: April 2019
Additional relevant MeSH terms:
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Mobility Limitation
Signs and Symptoms