Cognitive Decline, Dementia, Alzheimer's Disease, Mild Cognitive Impairment
Conditions
Keywords
exercise, neuropsychological, dementia, Alzheimer's Disease, mild cognitive impairment, strength, MCI, AD, EEG, neurophysiological, growth factor, cognitive decline, executive function
Brief summary
This study will evaluate the effects of low-intensity strengthening exercise on the brain (thinking and processing speed) for patients with early dementia, compared with normative older adults. Participants will engage in 3 months of exercise 3-5 times per week using a chair and small weights. It is hypothesized that there will be a significant improvement in brain function.
Detailed description
1. Objective(s): This study will evaluate the neuropsychological and neurophysiological effects of low-intensity strengthening exercise for patients with early dementia, compared with normative older adults. 2. Research Design: This is a quasi-experimental design in which change over time as a result of the exercise intervention will be compared with change over time seen in a normative sample. 3. Methodology: The aim is to enroll 12 participants with early dementia and 12 normative controls, all who are interested in starting a strengthening exercise program. Neuropsychological evaluation, resting electroencephalography (EEG), and event-related potentials (ERP) data collection will commence prior to the start of exercise. Participants will participate in an exercise class 2-3x/wk for three months. Repeat neuropsychological, EEG, and ERP evaluations will occur at the conclusion of three months of exercise. The exercises consist of low-intensity exercises, using a chair and small weights. A leader trained in the Tufts University exercise model will conduct the classes. 4. Findings: The investigators hypothesize a positive impact of exercise on neuropsychological function, especially performance on tasks requiring executive functions. This change will be compared with performance of normative controls who also exercise. Changes in brain function will be explored using EEG and ERP, and results are expected to be similar to prior research examining older adult exercisers which shows improvement in function.
Interventions
BEHAVIORALStrengthening exercise
3 months of 3-5 times per week of low-intensity exercises using a chair and small weights
Sponsors
US Department of Veterans Affairs
Union College, New York
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
55 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
* Adult Day Program Participants with early dementia able to consent or assent with surrogate permission * Control participants (55-100+ yo) able to participate at location with doctor permission
Exclusion criteria
* history of significant TBI, psychiatric condition, substance abuse, physical conditions that preclude participation in cognitive testing or strengthening exercises
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Stroop Test Performance From Pre- to Post-intervention | Baseline and 3 months | Average raw cognitive scores before (T1) and after (T2) strengthening exercise intervention. Lower scores on Stroop C (possible range 0-240 sec) represents better performance). |
| Digits Backwards Test Performance From Pre- to Post-intervention | Baseline and 3 months | Average raw cognitive scores before (T1) and after (T2) strengthening exercise intervention. Higher scores represent better performance (Digits backwards possible score range is 0-14 points). |
| Color Trails Test Performance From Pre- to Post-intervention | Baseline and 3 months | Average raw cognitive scores before (T1) and after (T2) strengthening exercise intervention. Higher scores represent better performance (Color Trails possible score range is 0-300 seconds). |
| Fuld Test Performance From Pre- to Post-intervention | Baseline and 3 months | Average raw cognitive scores before (T1) and after (T2) strengthening exercise intervention. Higher scores represent better performance (Fuld Semantic Recall possible score range is 0-20 points; Fuld Immediate and Delayed Recall possible score range is 0-10). |
| Figure Copy & Delayed Test Performance From Pre- to Post-intervention | Baseline and 3 months | Average raw cognitive scores before (T1) and after (T2) strengthening exercise intervention. Higher scores represent better performance (Figure Copy & Delayed possible score range is 0-36 points). |
| Neurophysiological Function Pre- & Post- Intervention | Baseline and 3 months | Resting EEG and ERP recordings before (T1) and after (T2) strengthening exercise intervention |
Countries
United States
Participant flow
Recruitment details
Early stage dementia participants were drawn from the Adult Day Care Program (ADCP) at a Veterans Affairs Medical Center (VAMC) in the northeast United States. Normative older adult participants were either employees or volunteers at the same facility recruited by fliers.
Participants by arm
| Arm | Count |
|---|---|
| Early Stage Dementia Individuals with early stage dementia who attended a Adult Day Care Program at least twice a week. | 13 |
| Normative Older Adults Normative older adults with no known history of neurological condition. | 9 |
| Total | 22 |
Baseline characteristics
| Characteristic | Early Stage Dementia | Normative Older Adults | Total |
|---|---|---|---|
| Age, Continuous | 79.3 years | 62.8 years | 71.5 years |
| Education | 11.5 years | 11.6 years | 11.6 years |
| Region of Enrollment United States | 13 participants | 9 participants | 22 participants |
| Sex: Female, Male Female | 0 Participants | 1 Participants | 1 Participants |
| Sex: Female, Male Male | 13 Participants | 8 Participants | 21 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 13 | 0 / 9 |
| serious Total, serious adverse events | 0 / 13 | 0 / 9 |
Outcome results
Primary
Color Trails Test Performance From Pre- to Post-intervention
Average raw cognitive scores before (T1) and after (T2) strengthening exercise intervention. Higher scores represent better performance (Color Trails possible score range is 0-300 seconds).
Time frame: Baseline and 3 months
Population: Two of 9 normative participants, had to be dropped from analyses due to limited participation in the exercise program (less than once per week on average; health problems and snowy weather were the main limiting factors) and one dementia exerciser was dropped because he did not complete any of the outcome measures.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Early Stage Dementia | Color Trails Test Performance From Pre- to Post-intervention | Color Trails 2 pre | 250.00 Time to complete (seconds) | Standard Deviation 186.45 |
| Early Stage Dementia | Color Trails Test Performance From Pre- to Post-intervention | Color Trails 2 post | 259.01 Time to complete (seconds) | Standard Deviation 197.63 |
| Normative Older Adults | Color Trails Test Performance From Pre- to Post-intervention | Color Trails 2 pre | 124.00 Time to complete (seconds) | Standard Deviation 67.97 |
| Normative Older Adults | Color Trails Test Performance From Pre- to Post-intervention | Color Trails 2 post | 96.11 Time to complete (seconds) | Standard Deviation 19.97 |
Primary
Digits Backwards Test Performance From Pre- to Post-intervention
Average raw cognitive scores before (T1) and after (T2) strengthening exercise intervention. Higher scores represent better performance (Digits backwards possible score range is 0-14 points).
Time frame: Baseline and 3 months
Population: Two of 9 normative participants, had to be dropped from analyses due to limited participation in the exercise program (less than once per week on average; health problems and snowy weather were the main limiting factors) and one dementia exerciser was dropped because he did not complete any of the outcome measures.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Early Stage Dementia | Digits Backwards Test Performance From Pre- to Post-intervention | Digits Backward pre | 4.10 Points | Standard Deviation 1.73 |
| Early Stage Dementia | Digits Backwards Test Performance From Pre- to Post-intervention | Digits Backward post | 3.90 Points | Standard Deviation 1.1 |
| Normative Older Adults | Digits Backwards Test Performance From Pre- to Post-intervention | Digits Backward pre | 5.50 Points | Standard Deviation 2.59 |
| Normative Older Adults | Digits Backwards Test Performance From Pre- to Post-intervention | Digits Backward post | 6.83 Points | Standard Deviation 2.71 |
Primary
Figure Copy & Delayed Test Performance From Pre- to Post-intervention
Average raw cognitive scores before (T1) and after (T2) strengthening exercise intervention. Higher scores represent better performance (Figure Copy & Delayed possible score range is 0-36 points).
Time frame: Baseline and 3 months
Population: Two of 9 normative participants, had to be dropped from analyses due to limited participation in the exercise program (less than once per week on average; health problems and snowy weather were the main limiting factors) and one dementia exerciser was dropped because he did not complete any of the outcome measures.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Early Stage Dementia | Figure Copy & Delayed Test Performance From Pre- to Post-intervention | Figure Copy pre | 16.44 Points | Standard Deviation 6.96 |
| Early Stage Dementia | Figure Copy & Delayed Test Performance From Pre- to Post-intervention | Figure Copy post | 22.06 Points | Standard Deviation 9.96 |
| Early Stage Dementia | Figure Copy & Delayed Test Performance From Pre- to Post-intervention | Figure Delayed Recall pre | 3.28 Points | Standard Deviation 4.41 |
| Early Stage Dementia | Figure Copy & Delayed Test Performance From Pre- to Post-intervention | Figure Delayed Recall post | 7.81 Points | Standard Deviation 4.52 |
| Normative Older Adults | Figure Copy & Delayed Test Performance From Pre- to Post-intervention | Figure Delayed Recall post | 18.25 Points | Standard Deviation 3.25 |
| Normative Older Adults | Figure Copy & Delayed Test Performance From Pre- to Post-intervention | Figure Copy pre | 28.67 Points | Standard Deviation 3.99 |
| Normative Older Adults | Figure Copy & Delayed Test Performance From Pre- to Post-intervention | Figure Delayed Recall pre | 14.50 Points | Standard Deviation 7.86 |
| Normative Older Adults | Figure Copy & Delayed Test Performance From Pre- to Post-intervention | Figure Copy post | 30.33 Points | Standard Deviation 3.62 |
Primary
Fuld Test Performance From Pre- to Post-intervention
Average raw cognitive scores before (T1) and after (T2) strengthening exercise intervention. Higher scores represent better performance (Fuld Semantic Recall possible score range is 0-20 points; Fuld Immediate and Delayed Recall possible score range is 0-10).
Time frame: Baseline and 3 months
Population: Two of 9 normative participants, had to be dropped from analyses due to limited participation in the exercise program (less than once per week on average; health problems and snowy weather were the main limiting factors) and one dementia exerciser was dropped because he did not complete any of the outcome measures.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Early Stage Dementia | Fuld Test Performance From Pre- to Post-intervention | Fuld Semantic Recall pre | 10.60 Points | Standard Deviation 3.66 |
| Early Stage Dementia | Fuld Test Performance From Pre- to Post-intervention | Fuld Semantic Recall post | 10.60 Points | Standard Deviation 4.27 |
| Early Stage Dementia | Fuld Test Performance From Pre- to Post-intervention | Fuld Immediate Recall pre | 2.90 Points | Standard Deviation 2.38 |
| Early Stage Dementia | Fuld Test Performance From Pre- to Post-intervention | Fuld Immediate Recall post | 4.40 Points | Standard Deviation 1.65 |
| Early Stage Dementia | Fuld Test Performance From Pre- to Post-intervention | Fuld Delayed Recall pre | 2.60 Points | Standard Deviation 2.41 |
| Early Stage Dementia | Fuld Test Performance From Pre- to Post-intervention | Fuld Delayed Recall post | 4.50 Points | Standard Deviation 2.72 |
| Normative Older Adults | Fuld Test Performance From Pre- to Post-intervention | Fuld Delayed Recall pre | 8.40 Points | Standard Deviation 1.14 |
| Normative Older Adults | Fuld Test Performance From Pre- to Post-intervention | Fuld Semantic Recall pre | 18.80 Points | Standard Deviation 8.76 |
| Normative Older Adults | Fuld Test Performance From Pre- to Post-intervention | Fuld Immediate Recall post | 7.60 Points | Standard Deviation 1.52 |
| Normative Older Adults | Fuld Test Performance From Pre- to Post-intervention | Fuld Semantic Recall post | 18.60 Points | Standard Deviation 5.86 |
| Normative Older Adults | Fuld Test Performance From Pre- to Post-intervention | Fuld Delayed Recall post | 8.20 Points | Standard Deviation 0.45 |
| Normative Older Adults | Fuld Test Performance From Pre- to Post-intervention | Fuld Immediate Recall pre | 6.60 Points | Standard Deviation 1.34 |
Primary
Neurophysiological Function Pre- & Post- Intervention
Resting EEG and ERP recordings before (T1) and after (T2) strengthening exercise intervention
Time frame: Baseline and 3 months
Primary
Stroop Test Performance From Pre- to Post-intervention
Average raw cognitive scores before (T1) and after (T2) strengthening exercise intervention. Lower scores on Stroop C (possible range 0-240 sec) represents better performance).
Time frame: Baseline and 3 months
Population: Two of 9 normative participants, had to be dropped from analyses due to limited participation in the exercise program (less than once per week on average; health problems and snowy weather were the main limiting factors) and one dementia exerciser was dropped because he did not complete any of the outcome measures.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Early Stage Dementia | Stroop Test Performance From Pre- to Post-intervention | Stroop C pre | 137.67 Time to complete (seconds) | Standard Deviation 102.3 |
| Early Stage Dementia | Stroop Test Performance From Pre- to Post-intervention | Stroop C post | 116.51 Time to complete (seconds) | Standard Deviation 64.44 |
| Normative Older Adults | Stroop Test Performance From Pre- to Post-intervention | Stroop C pre | 56.17 Time to complete (seconds) | Standard Deviation 10.34 |
| Normative Older Adults | Stroop Test Performance From Pre- to Post-intervention | Stroop C post | 55.13 Time to complete (seconds) | Standard Deviation 11.08 |