Mild Cognitive Impairment
Conditions
Brief summary
Vast evidence supports use of physical exercise and cognitive stimulation for lowering risk for cognitive decline and dementia, with combinations of non-pharmacological interventions providing greatest promise for impacting cognitive aging. This, paired with limited cognitive benefits from pharmacological interventions in dementia, has shifted focus to non-pharmacological interventions administered earlier in the disease course. This application, therefore, proposes a randomized controlled trial (RCT; 12-week active intervention, 3- and 6-month follow-up) comparing 3 conditions: walking program (guided progressive increases in weekly step counts), computer-based cognitive training program (Brain HQ, Posit Science), and combination of the exercise and cognitive program, on cognitive, functional, and diagnostic outcomes in 60 sedentary, community-dwelling adults with mild cognitive impairment (MCI).
Interventions
BEHAVIORALWalking Intervention
The walking intervention will begin following baseline assessments and will be continued for 12 weeks. Participants will be given a pedometer to use daily and log their daily steps, with an identified goal of increasing step counts by 3000 steps a day over the course of the intervention. After obtaining a week long baseline step count, individuals in the intervention group will progressively increase their step counts by 100 steps daily each week for the first three weeks, by 200 steps daily for weeks four through six, by 300 steps daily for weeks seven through nine, and by 400 steps daily for weeks ten through twelve. Mean baseline step counts for sedentary older adults in our pilot work were 4150 per day; therefore, most participants will almost double their daily activity by the end of the intervention.
BEHAVIORALCognitive Training Intervention
In the CT condition, participants will use Brain HQ, a computer cognitive training program (Posit Science Corporation, San Francisco, CA), shown to be well tolerated by older adults with positive short- and long-term cognitive outcomes. Participants will use the program 60 minutes/day, 5 days/week for 12 weeks. If participants do not have a home computer/internet access, they can complete the modules at another location such as a public library, senior center, or at the MARC, but training will still be self-directed.
BEHAVIORALCombined Intervention
The combined condition will concurrently follow both the walking and the CT programs as described above.
Sponsors
Alzheimer's Association
University of California, San Diego
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
60 Years to 80 Years
Healthy volunteers
Yes
Inclusion criteria
* MCI diagnosis (can be self referral, will determine eligibility at baseline)
Exclusion criteria
* Dementia diagnosis * Head trauma * Neuro/psychiatric disorders * Current substance dependence * Sensory/mobility deficits * No more than 1 hour of purposeful, aerobic activity/week * Currently engaging in any other brain-stimulating computer program (No more than 1 hour a week)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Rivermead Behavioral Memory Test | 12 weeks | The Rivermead Behavioral Memory Test (RBMT) is an ecologically valid assessment of cognitive functioning that tests some skills specifically trained in the CT condition (e.g., name learning, and story learning) but also additional untrained skills such as prospective memory. Belongings subtest scaled scores: Minimum score = 1, Maximum score = 19; higher values represent better performance. |
| Everyday Cognition Scale | 12 weeks | The Everyday Cognition Scale (ECog) assesses (via informant report) everyday cognitive functioning in memory, language, visuospatial, and executive functioning domains. Average total score was used: Minimum = 1, Maximum = 4, higher scores indicate greater impairment |
| Older Peoples Quality of Life Questionnaire | 12 weeks | Self report assessment of quality of life specific to older adults. Assessment covers life overall, health, social relationships and participation, independence, control over life and freedom, home and neighborhood, psychological and emotional well-being, financial circumstances, leisure/activities, and culture and religion. Total score minimum = 35, max = 175; lower scores indicate better quality of life. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Walking Intervention Walking Intervention: The walking intervention will begin following baseline assessments and will be continued for 12 weeks. Participants will be given a pedometer to use daily and log their daily steps, with an identified goal of increasing step counts by 3000 steps a day over the course of the intervention. After obtaining a week long baseline step count, individuals in the intervention group will progressively increase their step counts by 100 steps daily each week for the first three weeks, by 200 steps daily for weeks four through six, by 300 steps daily for weeks seven through nine, and by 400 steps daily for weeks ten through twelve. Mean baseline step counts for sedentary older adults in our pilot work were 4150 per day; therefore, most participants will almost double their daily activity by the end of the intervention. | 18 |
| Cognitive Training Intervention Cognitive Training Intervention: In the CT condition, participants will use Brain HQ, a computer cognitive training program (Posit Science Corporation, San Francisco, CA), shown to be well tolerated by older adults with positive short- and long-term cognitive outcomes. Participants will use the program 60 minutes/day, 5 days/week for 12 weeks. If participants do not have a home computer/internet access, they can complete the modules at another location such as a public library, senior center, or at the MARC, but training will still be self-directed. | 13 |
| Combined Intervention Combined Intervention: The combined condition will concurrently follow both the walking and the CT programs as described above. | 21 |
| Total | 52 |
Baseline characteristics
| Characteristic | Walking Intervention | Cognitive Training Intervention | Combined Intervention | Total |
|---|---|---|---|---|
| Age, Continuous | 72.06 years STANDARD_DEVIATION 5.79 | 64.0 years STANDARD_DEVIATION 4.06 | 69.48 years STANDARD_DEVIATION 6.32 | 69.0 years STANDARD_DEVIATION 6.37 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 0 Participants | 1 Participants | 0 Participants | 1 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 18 Participants | 12 Participants | 20 Participants | 50 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 1 Participants | 1 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 3 Participants | 0 Participants | 3 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants | 1 Participants | 0 Participants | 1 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 1 Participants | 1 Participants | 2 Participants |
| Race (NIH/OMB) White | 18 Participants | 8 Participants | 20 Participants | 46 Participants |
| Sex: Female, Male Female | 11 Participants | 10 Participants | 15 Participants | 36 Participants |
| Sex: Female, Male Male | 7 Participants | 3 Participants | 6 Participants | 16 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 18 | 0 / 13 | 0 / 21 |
| other Total, other adverse events | 0 / 18 | 0 / 13 | 0 / 21 |
| serious Total, serious adverse events | 0 / 18 | 0 / 13 | 0 / 21 |
Outcome results
Primary
Everyday Cognition Scale
The Everyday Cognition Scale (ECog) assesses (via informant report) everyday cognitive functioning in memory, language, visuospatial, and executive functioning domains. Average total score was used: Minimum = 1, Maximum = 4, higher scores indicate greater impairment
Time frame: 12 weeks
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Walking Intervention | Everyday Cognition Scale | 1.50 units on a scale | Standard Deviation 0.64 |
| Cognitive Training Intervention | Everyday Cognition Scale | 1.14 units on a scale | Standard Deviation 0.17 |
| Combined Intervention | Everyday Cognition Scale | 1.24 units on a scale | Standard Deviation 0.3 |
Primary
Older Peoples Quality of Life Questionnaire
Self report assessment of quality of life specific to older adults. Assessment covers life overall, health, social relationships and participation, independence, control over life and freedom, home and neighborhood, psychological and emotional well-being, financial circumstances, leisure/activities, and culture and religion. Total score minimum = 35, max = 175; lower scores indicate better quality of life.
Time frame: 12 weeks
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Walking Intervention | Older Peoples Quality of Life Questionnaire | 76.08 units on a scale | Standard Deviation 20.74 |
| Cognitive Training Intervention | Older Peoples Quality of Life Questionnaire | 72.20 units on a scale | Standard Deviation 7.46 |
| Combined Intervention | Older Peoples Quality of Life Questionnaire | 68.15 units on a scale | Standard Deviation 16.01 |
Primary
Rivermead Behavioral Memory Test
The Rivermead Behavioral Memory Test (RBMT) is an ecologically valid assessment of cognitive functioning that tests some skills specifically trained in the CT condition (e.g., name learning, and story learning) but also additional untrained skills such as prospective memory. Belongings subtest scaled scores: Minimum score = 1, Maximum score = 19; higher values represent better performance.
Time frame: 12 weeks
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Walking Intervention | Rivermead Behavioral Memory Test | 11.08 units on a scale | Standard Deviation 3.8 |
| Cognitive Training Intervention | Rivermead Behavioral Memory Test | 11.2 units on a scale | Standard Deviation 2.95 |
| Combined Intervention | Rivermead Behavioral Memory Test | 12.31 units on a scale | Standard Deviation 1.93 |