The purpose of this study is to generate preliminary data on the benefit of computerized cognitive training and Tai Chi- Qi Gong training in participants with Early-Onset Alzheimer's Disease. It is hypothesized that participants in the experimental training condition will perform better on outcomes related to cognition, functioning, and mood at follow-up compared to participants assigned to the active control condition.
This study aims to generate preliminary data regarding the efficacy of a combined cognitive-training and Tai Chi- Qi Gong exercise lifestyle intervention in participants diagnosed with Early-Onset Alzheimer's Disease (EOAD). Participants will complete a series of cognitive, functional, and mood assessments at a remotely-assessed baseline visit, and then be randomized into one of two conditions: (1) Computerized Cognitive Training + Tai Chi Exercise or (2) Active Control. Outcome measures will be repeated immediately Post-Treatment and at 6-months post-treatment Follow-Up. Specific Aim 1 will examine the feasibility of this lifestyle intervention and outcome assessments when applied to participants with EOAD. Specific Aim 2 will investigate if this lifestyle intervention improves short- and long-term cognition, functioning, and mood. Specific Aim 3 will be exploratory to assess whether individual differences in training or clinical/ demographic characteristics moderate the degree of benefit from this intervention; owing to sample size limitations in this feasibility study, focus of this latter aim will be on determining effect sizes and sample-size magnitude needed for future work.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
DOUBLE
Enrollment
60
Participants will be asked to complete approximately 45 minutes of training, 4-5 sessions per week for 14 weeks (corresponding to approximately 40 hours of training total). Training will be completed via BrainHQ, a mobile application that, as used in this study, meets the FDA's definition of a medical device.
Participants will be asked to complete 14 hours of training total (in 30-minute sessions, 2 days per week for 14 weeks).
Participants will be asked to complete 40 hours of training total (in 45-minute sessions, 4 to 5 days per week for 14 weeks). Training will be completed via BrainHQ, a mobile application that, as used in this study, meets the FDA's definition of a medical device.
Indiana University
Indianapolis, Indiana, United States
RECRUITINGPerformance on CANTAB Connect computerized Memory Composite immediately post-intervention, after controlling for baseline performance
CANTAB Connect computerized Memory Composite was selected for its remote assessment of memory, with validation in Alzheimer's Disease samples. This composite will be calculated from Paired Associates Learning, Pattern Recognition Memory, and Verbal Paired Associates subtests, with higher scores reflected better performance.
Time frame: 15-Week Post-Intervention Follow-up
Performance on CANTAB Connect computerized Executive Composite immediately post-intervention, after controlling for baseline performance
CANTAB Connect computerized Executive Composite was selected for its remote assessment of executive functioning, with validation in Alzheimer's Disease samples. This composite will be calculated from Stockings of Cambridge, Spatial Working Memory, Rapid Visual Processing, and Match To Sample subtests, with higher scores reflected better performance.
Time frame: 15-Week Post-Intervention Follow-up
Performance on CANTAB Connect computerized Memory Composite 26 weeks after intervention, after controlling for baseline performance
CANTAB Connect computerized Memory Composite was selected for its remote assessment of memory, with validation in Alzheimer's Disease samples. This composite will be calculated from Paired Associates Learning, Pattern Recognition Memory, and Verbal Paired Associates subtests, with higher scores reflected better performance.
Time frame: 40-Week Post-Intervention Follow-up
Performance on CANTAB Connect computerized Executive Composite 26 weeks after intervention, after controlling for baseline performance
CANTAB Connect computerized Executive Composite was selected for its remote assessment of executive functioning, with validation in Alzheimer's Disease samples. This composite will be calculated from Stockings of Cambridge, Spatial Working Memory, Rapid Visual Processing, and Match To Sample subtests, with higher scores reflected better performance.
Time frame: 40-Week Post-Intervention Follow-up
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Participants will be asked to engage in stretching exercises twice per week, for approximately 15 minutes per session. This will total of approximately 7 hours over the course of 14 weeks.
Benefit from Cognitive Training using Cognitive Self-Report Questionnaire immediately post-intervention, after controlling for baseline performance
Cognitive Self-Report Questionnaire is a 25-item self-report questionnaire of subjective cognitive difficulties. Scores range from 0-125, with higher scores denoting greater cognitive symptoms. This measure has been used in a variety of studies examining benefit from cognitive training.
Time frame: 15-Week Post-Intervention Follow-up
Benefit from Cognitive Training using Cognitive Self-Report Questionnaire 26 weeks after intervention, after controlling for baseline performance
Cognitive Self-Report Questionnaire is a 25-item self-report questionnaire of subjective cognitive difficulties. Scores range from 0-125, with higher scores denoting greater cognitive symptoms. This measure has been used in a variety of studies examining benefit from cognitive training.
Time frame: 40-Week Post-Intervention Follow-up
Performance on scales of functioning immediately post-intervention, after controlling for baseline performance
The Alzheimer's Disease Cooperative Study - Activities of Daily Living Inventory is an informant-based rating scale that assesses the participant's ability to perform a variety of activities of daily living over the past four weeks, and has been shown to discriminate between healthy elderly controls and those with mild Alzheimer's disease. Scores range from 0-78, with higher scores denoting better functional ability.
Time frame: 15-Week Post-Intervention Follow-up
Performance on scales of functioning 26 weeks after intervention, after controlling for baseline performance
The Alzheimer's Disease Cooperative Study - Activities of Daily Living Inventory is an informant-based rating scale that assesses the participant's ability to perform a variety of activities of daily living over the past four weeks, and has been shown to discriminate between healthy elderly controls and those with mild Alzheimer's disease. Scores range from 0-78, with higher scores denoting better functional ability.
Time frame: 40-Week Post-Intervention Follow-up
Self-reported depression immediately post-intervention, after controlling for baseline performance
21-item Beck Depression Inventory-2 was used as a measure of self-reported depression. Scores range from 0-63, with higher scores denoting greater self-reported depression symptoms.
Time frame: 15-Week Post-Intervention Follow-up
Self-reported depression 26 weeks after intervention, after controlling for baseline performance
21-item Beck Depression Inventory-2 was used as a measure of self-reported depression. Scores range from 0-63, with higher scores denoting greater self-reported depression symptoms.
Time frame: 40-Week Post-Intervention Follow-up
Self-reported quality of life immediately post-intervention, after controlling for baseline performance
13-item Quality of Life- Alzheimer's Disease scale was used as a measure of self-reported quality of life. Scores range from 13-52, with higher scores denoting greater self-reported quality of life.
Time frame: 15-Week Post-Intervention Follow-up
Self-reported quality of life 26 weeks after intervention, after controlling for baseline performance
13-item Quality of Life- Alzheimer's Disease scale was used as a measure of self-reported quality of life. Scores range from 13-52, with higher scores denoting greater self-reported quality of life.
Time frame: 40-Week Post-Intervention Follow-up
Self-reported stress immediately post-intervention, after controlling for baseline performance
4-item Perceived Stress Scale was used as a measure of self-reported stress. Scores range from 0-16, with higher scores denoting greater stress.
Time frame: 15-Week Post-Intervention Follow-up
Self-reported stress 26 weeks after intervention, after controlling for baseline performance
4-item Perceived Stress Scale was used as a measure of self-reported stress. Scores range from 0-16, with higher scores denoting greater stress.
Time frame: 40-Week Post-Intervention Follow-up
Self-reported perceived social support immediately post-intervention, after controlling for baseline performance
6-Item Multidimensional Scale of Perceived Social Support (MSPSS-6) was used as a measure of self-reported support from family, friends, and a significant other. Scores range from 1-7, with higher scores denoting greater perceived social support.
Time frame: 15-Week Post-Intervention Follow-up
Self-reported perceived social support 26 weeks after intervention, after controlling for baseline performance
6-Item Multidimensional Scale of Perceived Social Support (MSPSS-6) was used as a measure of self-reported support from family, friends, and a significant other. Scores range from 1-7, with higher scores denoting greater perceived social support.
Time frame: 40-Week Post-Intervention Follow-up