Mild Cognitive Impairment
Conditions
Brief summary
The investigators will conduct a 8-week proof-of-concept randomized controlled trial to provide preliminary evidence of efficacy of Fit Brains (Rosetta Stone Canada) training -- a mobile cognitive training program -- on cognitive and brain plasticity in older adults. The investigators will also explore whether Fit Brains training paired with a brief bout of exercise would enhance the potential cognitive benefits of Fit Brains. In addition, the investigators will explore the long-term effects of cognitive training by performing a 1-year follow-up measurement (i.e., 1-year after study completion).
Detailed description
This study will look at the effect of FBT on cognitive function in older adults. Additionally, the investigators aim to explore whether a single bout of aerobic exercise prior to Fit Brains training would magnify the training effect on both cognitive and brain outcomes. Objectives: 1\) To compare the effect of Fit Brains training (FBT) and the effect of a single bout of aerobic exercise prior to FBT (Ex-FBT) with a Balanced And Tone (BAT; control) program on cognitive performance in both older adults; 2) To explore the effect of FBT and Ex-FBT with BAT on brain structure and function i; 3) To explore whether the intervention effects (i.e., FBT and Ex-FBT) are moderated by cognitive status (i.e., MCI or not); 4) To explore whether Ex-FBT has additional benefits compared with FBT; and 5) To explore whether potential benefits are maintained at 1-year follow-up. Research Method: The investigators will conduct an 8-week proof-of-concept, assessor single-blinded randomized controlled trial (RCT) with 120 older adults (i.e., 40 in each experimental group). A subset of participants will perform MRI scans at baseline and 8-weeks. To reduce bias, all assessors will be blinded to group allocation of participants. Participants will be randomly assigned to one of the three groups (i.e., FBT, Ex-FBT, or SCT). Participants in the FBT group will be required to attend 3 formal training sessions per week, for 8 weeks, at the Djavad Mowafaghian Centre for Brain Health or the Centre for Hip Health and Mobility. Each session will be for 60 minutes. Additionally, the participants will be asked to complete 3 additional one-hour training sessions at home per week. Thus, the participants will complete a total of 48 hours of cognitive training over 8 weeks. Participants who are randomized to Ex-FBT will be required to attend 3 formal training sessions per week, for 8 weeks, at the Djavad Mowafaghian Centre for Brain Health or Centre for Hip Health and Mobility. Each session will be for 1 hour. The participants will start the training with a 15-minute walk outside. The 15-minute walk is followed by a 45-minute FBT session (FBT program). Additionally, participants will be asked to complete 3 additional 1-hour training sessions at home (i.e., 15-minute walk followed by 45-minutes of FBT training). Thus, the participants will complete a total of 48 hours of cognitive + walking training over 8 weeks. Participants who are randomly assigned to the BAT group will be required to attend 3 formal training sessions per week, for 8 weeks, at both the Djavad Mowafaghian Centre for Brain Health and/or the Centre for Hip Health and Mobility. Specifically, the participants will complete a total of 8 hours of sham cognitive training, 8 hours of sham exercise training (Centre for Hip Health and Mobility) and 8 hours of education over the 8 weeks. Thus, the participants will complete a total of 24 hours of sham training over 8 weeks.
Interventions
BEHAVIORALFit Brains Training
These hourly classes will consist of cognitive brain training (Fit Brains by Rosetta Stone) on a mobile device (tablet/iPad). Fit Brains offers 60+ different training games, each targeting one of five cognitive domains - executive functions, memory, concentration/attention, visual-spatial ability, and processing speed. Each game lasts exactly 60 seconds during which individuals aim to answer as many questions correctly. The difficulty of the game increases after each correct answer. Each game has three level of difficulty: 1) novice; 2) intermediate; and 3) advanced.
BEHAVIORALExercise + Fit Brains Training
These classes combine aerobic training and cognitive training. The classes will consist of a 15-minute walk prior to cognitive brain training (Fit Brains by Rosetta Stone) on a mobile device (tablet/iPad). Fit Brains offers 60+ different training games, each targeting one of five cognitive domains - executive functions, memory, concentration/attention, visual-spatial ability, and processing speed. Each game lasts exactly 60 seconds during which individual aims to answer as many questions correctly. The difficulty of the game increases after each correct answer. Each game has three level of difficulty: 1) novice; 2) intermediate; and 3) advanced.
BEHAVIORALBalanced And Tone
These classes will consist of hourly sham training class, hourly classes of sham exercise (e.g., balance, stretching, range of motion), and hourly educational classes.
Sponsors
Mitacs
University of British Columbia
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
65 Years to 85 Years
Healthy volunteers
Yes
Inclusion criteria
* aged between 65 and 85 years * completed high school education * live in their own home * read, write, and speak English with acceptable visual and auditory acuity * have preserved general cognitive function as indicated by a Mini-Mental State Examination score * score \> 6/8 on the Lawton and Brody Instrumental Activities of Daily Living Scale * are not expected to start or are stable on a fixed dose of anti-dementia medications (e.g., donepezil, galantamine, etc.) during the 8-week study period * are able to walk independently; * are suitable to engage in 15-minutes of brisk walking based on the Physical Activity Readiness Questionnaire; and * provide a personally signed and dated informed consent document indicating that the individual has been informed of all pertinent aspects of the study.
Exclusion criteria
* diagnosed with dementia of any type * clinically suspected to have neurodegenerative disease as the cause of MCI that is not AD, vascular dementia (VaD), or both (e.g. multiple sclerosis, Parkinson's disease, Huntington's disease, fronto-temporal dementia, etc.) * have clinically significant peripheral neuropathy or severe musculoskeletal or joint disease that impairs mobility, as determined by his/her family physician * taking medications that may negatively affect cognitive function, such as anticholinergics, including agents with pronounced anticholinergic properties (e.g., amitriptyline), major tranquilizers (i.e., typical and atypical antipsychotics), and anticonvulsants (e.g., gabapentin, valproic acid, etc.) * planning to participate, or already enrolled in, a concurrent clinical drug trial Specific
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change from baseline in episodic memory as measured with the Rey Auditory Verbal Learning Test (RAVLT) at 8 weeks and 1-year follow-up | Measured at baseline and at program completion (8 weeks), and 1-year follow-up | Measured by the Rey Auditory Verbal Learning Test (RAVLT) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change from baseline in set shifting as measured with the Trailmaking A and B test at 8 weeks and 1-year follow-up | Measured at baseline and at program completion (8 weeks), and 1-year follow-up | Measured by Standard Neuropsychological Tests and the NIH Toolbox |
| Change from baseline in working memory as measured with the digits forward and backward test at 8 weeks and 1-year follow-up | Measured at baseline and at program completion (8 weeks), and 1-year follow-up | Measured by Standard Neuropsychological Tests and the NIH Toolbox |
| Change from baseline in functional capacity as measured by the 6-Minute Walk Test at 8 weeks and 1-year follow-up | Measured at baseline and at program completion (8 weeks), and 1-year follow-up | Measured by the 6-Minute Walk Test |
| Change from baseline in response inhibition as measured with the stroop test at 8 weeks and 1-year follow-up | Measured at baseline and at program completion (8 weeks), and 1-year follow-up | Measured by Standard Neuropsychological Tests and the NIH Toolbox |
| Change from baseline in brain structure as measured by structural MRI at 8 weeks | Measured at baseline and at program completion (8 weeks). | Measured by structural MRI |
| Change from baseline in brain function as measured by resting state functional MRI at 8 weeks | Measured at baseline and at program completion (8 weeks). | Measured by resting state functional MRI |
| Change from baseline in mobility as measured by the Short Physical Performance Battery (SPPB) at 8 weeks | Measured at baseline and at program completion (8 weeks). | Measured by the Short Physical Performance Battery |
Countries
Canada
Outcome results
None listed