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This project is assessing the feasibility of a novel home-based exercise intervention to improve episodic memory in individuals with mild cognitive impairment.
Background/Rationale:
Alzheimer's disease (AD) afflicts nearly 6 million Americans, a number projected to grow in coming decades. AD is known to have a long preclinical phase in which pathophysiologic processes develop many years, even decades, before the onset of clinical symptoms. During this preclinical phase there is evidence of unremitting decline in cognitive function, particularly in episodic memory. Thus far, evidence of the efficacy of pharmacological interventions to slow this decline in cognitive function has been limited, leading to increasing interest in the utility of nonpharmacological interventions including exercise.
Objective:
The investigators propose to assess the feasibility of a novel home-based exercise intervention to improve episodic memory in Veterans with mild cognitive impairment (MCI).
Methods:
The investigators will estimate the difference between the intervention (n=30) and the control group (n=30) on 6-month change in episodic memory (Rey-Osterrieth Complex Figure Test, Wechsler Logical Memory Test) as well as the effect size, which will be used as a basis for sample size calculation for a proposed larger study. Participants will be male and female Veterans 50 years of age or older with amnestic MCI.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Exercise group | Experimental | Structured exercise |
|
| Control group | Active Comparator | Health education |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Structured exercise | Behavioral | Exercise instruction and encouragement |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Delayed Recall Score on Wechsler Logical Memory Task From Baseline to 6 Months | Wechsler Logical Memory Task is a recall test involving 2 short stories. Possible scores on the delayed recall task range from 0 (no details recalled for both stories) to 50 (all details recalled on both stories). Outcome is change in the delayed recall score from baseline to 6 months. | baseline and 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Delayed Recall Score on the Rey-Osterrieth Complex Figure Test From Baseline to 6 Months | Rey-Osterrieth Complex Figure Test is a recall test involving a complex figure. Possible scores on the delayed recall task range from 0 (no accurate details recalled for the figure) to 36 (all details accurately recalled for the figure). Outcome is change in the delayed recall score from baseline to 6 months. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| David Sparrow, DSc | VA Boston Healthcare System Jamaica Plain Campus, Jamaica Plain, MA | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| VA Boston Healthcare System Jamaica Plain Campus, Jamaica Plain, MA | Boston | Massachusetts | 02130 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | Exercise Group | Structured exercise Structured exercise: Exercise instruction and encouragement |
| FG001 | Control Group | Health education Health Education: Provision of general information about a variety of health topics |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Exercise Group | Structured exercise Structured exercise: Exercise instruction and encouragement |
| BG001 | Control Group | Health education Health Education: Provision of general information about a variety of health topics |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Change in Delayed Recall Score on Wechsler Logical Memory Task From Baseline to 6 Months | Wechsler Logical Memory Task is a recall test involving 2 short stories. Possible scores on the delayed recall task range from 0 (no details recalled for both stories) to 50 (all details recalled on both stories). Outcome is change in the delayed recall score from baseline to 6 months. | Posted | Mean | Standard Deviation | units on a scale | baseline and 6 months |
|
6 months
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Exercise Group | Structured exercise Structured exercise: Exercise instruction and encouragement |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. David Sparrow | VA Boston Healthcare System | 857-364-6400 | david.sparrow@va.gov |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Jan 29, 2018 | May 31, 2023 | Prot_SAP_001.pdf |
| ICF | No | No | Yes | Informed Consent Form | Feb 24, 2020 | Aug 18, 2022 | ICF_000.pdf |
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| ID | Term |
|---|---|
| D060825 | Cognitive Dysfunction |
| D010349 | Patient Compliance |
| ID | Term |
|---|---|
| D003072 | Cognition Disorders |
| D019965 | Neurocognitive Disorders |
| D001523 | Mental Disorders |
| D010342 | Patient Acceptance of Health Care |
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| Health Education |
| Behavioral |
Provision of general information about a variety of health topics |
|
| baseline and 6 months |
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Wechsler Logical Memory Task | A recall test involving 2 short stories. Possible scores on the delayed recall task range from 0 (no details recalled for both stories) to 50 (all details recalled on both stories). | Mean | Standard Deviation | units on a scale |
|
| Rey-Osterrieth Complex Figure Test | A recall test involving a complex figure. Possible scores on the delayed recall task range from 0 (no accurate details recalled for the figure) to 36 (all details accurately recalled for the figure). | Mean | Standard Deviation | units on a scale |
|
|
|
|
| Secondary | Change in Delayed Recall Score on the Rey-Osterrieth Complex Figure Test From Baseline to 6 Months | Rey-Osterrieth Complex Figure Test is a recall test involving a complex figure. Possible scores on the delayed recall task range from 0 (no accurate details recalled for the figure) to 36 (all details accurately recalled for the figure). Outcome is change in the delayed recall score from baseline to 6 months. | Posted | Mean | Standard Deviation | units on a scale | baseline and 6 months |
|
|
|
|
| 0 |
| 29 |
| 0 |
| 29 |
| 0 |
| 29 |
| EG001 | Control Group | Health education Health Education: Provision of general information about a variety of health topics | 0 | 31 | 0 | 31 | 0 | 31 |
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| D000074822 | Treatment Adherence and Compliance |
| D015438 | Health Behavior |
| D001519 | Behavior |