N/A
N=383
Cognitive Remediation to Improve Mobility in Sedentary Seniors
Mobility Limitation · Motor Activity · Difficulty Walking · Cognitive Ability General
Bottom Line
View on ClinicalTrials.gov: NCT02567227 ↗Enrolled (actual)
383
Serious AEs
1.6%
Results posted
Jun 2021
Primary outcome: Primary: Change in Walking Speed During Single and Dual-task Conditions. — 1.73; 2.76; 6.02; 5.43 centimeters per second
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Cognitive Remediation (Other); Active Control (Other)
- Age
- Older Adult · 70+ yrs
- Sex
- All
- Sponsor
- Albert Einstein College of Medicine
- Primary completion
- Jun 2020
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change in Walking Speed During Single and Dual-task Conditions. |
1.73; 2.76; 6.02; 5.43 | — |
| SECONDARY Change in Short Physical Performance Battery (SPPB). |
0.70; 0.85 | — |
| SECONDARY Stride Length. |
3.09; 2.26; 0.13; 2.08 | — |
| SECONDARY Gait Variability. |
-0.37; -0.13; -0.52; -0.08 | — |
| SECONDARY Variability in Gait Domains |
0.21; 0.37; 0.36; 0.25; 0.07; -0.15 | — |
| SECONDARY Number of Participants With Substantial Gait Speed Change. |
10; 11; 142; 151; 23; 25 | — |
| SECONDARY Flanker Task. |
-9.05; -1.54 | — |
| SECONDARY Digit Symbol Substitution Test. |
2.22; 1.21 | — |
| SECONDARY Trail Making Test Form A. |
-0.06; -0.07 | — |
| SECONDARY Trail Making Test Form B. |
-0.10; -0.10 | — |
| SECONDARY Controlled Oral Word Association Test. |
1.20; 0.53 | — |
| SECONDARY Repeatable Battery for the Assessment of Neuropsychological Status. |
— | — |
| SECONDARY Neuroplasticity. |
— | — |
| SECONDARY Durability |
-0.47; -1.60; 3.16; 1.77 | — |
| SECONDARY Stair Climbing Time. |
-0.02; 0.01 | — |
| SECONDARY Disability Scale. |
-0.18; -0.21 | — |
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.
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. -
Data sourced from ClinicalTrials.gov (NCT02567227). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.