Cognitive Remediation to Improve Mobility in Sedentary Seniors (CREM)

Albert Einstein College of Medicine

Status: Completed

Conditions: Difficulty Walking; Cognitive Ability General; Motor Activity; Mobility Limitation

Treatments: Other: Active Control; Other: Cognitive Remediation

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT02567227

2015-4752

R01AG050448-01 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

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.

Full 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.

Enrollment: 383 patients

Sex: All

Ages: 70+ years old

Volunteers: Accepts Healthy Volunteers

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. -

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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383 participants in 2 patient groups

Cognitive Remediation

Experimental group

Description:

An individualized computerized cognitive remediation program.

Treatment:

Other: Cognitive Remediation

Active control

Active Comparator group

Description:

Individualized computer based exposure and interactive health education classes.

Treatment:

Other: Active Control