Clinical trial NCT02567227: Cognitive Remediation to Improve Mobility in Sedentary Seniors
Official title: Cognitive Intervention to Improve Simple and Complex Walking
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Mobility Limitation
Motor Activity
Difficulty Walking
Cognitive Ability General
Lead sponsor: Albert Einstein College of Medicine
Sponsor class: OTHER
Collaborators: name: National Institute on Aging (NIA)
First posted: 2015-10-02
Enrollment: 383
Sex: ALL
Minimum age (years): 70
Standard ages: OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility 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. -

Primary outcomes:
measure: Change in Walking Speed During Single and Dual-task Conditions.
timeFrame: Baseline and 2 months
Secondary outcomes:
measure: Change in Short Physical Performance Battery (SPPB).
timeFrame: Baseline and 2 months
measure: Stride Length.
timeFrame: Baseline and 2 months
measure: Gait Variability.
timeFrame: Baseline and 2 months
measure: Variability in Gait Domains
timeFrame: Baseline and 2 Months
measure: Number of Participants With Substantial Gait Speed Change.
timeFrame: Baseline and 2 Months
measure: Flanker Task.
timeFrame: Baseline and 2 Months
measure: Digit Symbol Substitution Test.
timeFrame: Baseline and 2 Months
measure: Trail Making Test Form A.
timeFrame: Baseline and 2 Months
measure: Trail Making Test Form B.
timeFrame: Baseline and 2 Months
measure: Controlled Oral Word Association Test.
timeFrame: Baseline and 2 Months
measure: Repeatable Battery for the Assessment of Neuropsychological Status.
timeFrame: Baseline and 2 Months
measure: Neuroplasticity.
timeFrame: Baseline and 2 Months
measure: Durability
timeFrame: Baseline and 6 months
measure: Stair Climbing Time.
timeFrame: Baseline and 2 Months
measure: Disability Scale.
timeFrame: Baseline and 2 Months
Other outcomes:
measure: The Geriatric Depression Scale (GDS).
timeFrame: Baseline and 2 months
measure: Rosenberg Self-Esteem Scale.
timeFrame: Baseline and 2 months
measure: Falls Efficacy Scale.
timeFrame: Baseline and 2 months
measure: 12-Item Short Form Health Survey (SF-12).
timeFrame: Baseline and 2 months
measure: Falls.
timeFrame: Baseline and 12 Months
measure: Number of Participants With Progression in Cognitive Impairment From Normal Cognitive Function at Baseline to Mild Cognitive Impairment (MCI)
timeFrame: Baseline and 2 Months
measure: Number of Participants With Progression in Cognitive Impairment From Normal Cognitive Function at Baseline to Dementia
timeFrame: Baseline and 2 Months
measure: Number of Participants With Progression in Cognitive Impairment From Normal Cognitive Function at Baseline to Motoric Cognitive Risk Syndrome (MCR)
timeFrame: Baseline and 2 Months
measure: Number of Participants With Progression in Cognitive Impairment From Normal Cognitive Function at Baseline to Cognitively Impaired
timeFrame: Baseline and 2 Months
Locations:
city: Bronx
country: United States
facility: Albert Einstein College of Medicine
state: New York
Study officials:
affiliation: Albert Einstein College of Medicine
name: Joe Verghese, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Albert Einstein College of Medicine
name: Roee Holtzer, PhD
role: PRINCIPAL_INVESTIGATOR
References:
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.
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.
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.