Cognitive Brain Training in Older Adults

Mild Cognitive Impairment Clinical Trial

Official title:

The Effect of Fit Brains Training on Cognitive Performance in Older Adults

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02564809
• Other study ID #: H14-02438
• Status: Completed
• Phase: N/A
• Start date: January 2016
• Est. completion date: September 2018

Study information

• Verified date: May 2019
• Source: University of British Columbia
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 123
• Est. completion date: September 2018
• Est. primary completion date: September 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 65 Years to 85 Years

Eligibility

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 exclusion criteria for the MRI subset:

• Participants do not meet the specific scanning requirements of the UBC MRI Research Centre. Specifically, the investigators will exclude anyone with: pacemaker, brain aneurysm clip, cochlear implant, surgery or tattoos within the past 6 weeks, electrical stimulator for nerves or bones, implanted infusion pump, history of any eye injury involving metal fragments, artificial heart valve, orthopedic hardware, other metallic prostheses, coil, catheter or filter in any blood vessel, ear or eye implant, bullets, or other metallic fragments.

Related Conditions & MeSH terms

• Cognitive Dysfunction
• Mild Cognitive Impairment

Intervention

Behavioral:
• Fit 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.
• Exercise + 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.
• Balanced 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.

Locations

Country	Name	City	State
Canada	Djavad Mowafaghian Centre for Brain Health & Centre for Hip Health and Mobility	Vancouver	British Columbia

Sponsors (2)

Lead Sponsor	Collaborator
University of British Columbia	Mitacs

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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 by the Rey Auditory Verbal Learning Test (RAVLT)	Measured at baseline and at program completion (8 weeks), and 1-year follow-up
Secondary	Change from baseline in response inhibition as measured with the stroop test at 8 weeks and 1-year follow-up	Measured by Standard Neuropsychological Tests and the NIH Toolbox	Measured at baseline and at program completion (8 weeks), and 1-year follow-up
Secondary	Change from baseline in set shifting as measured with the Trailmaking A and B test at 8 weeks and 1-year follow-up	Measured by Standard Neuropsychological Tests and the NIH Toolbox	Measured at baseline and at program completion (8 weeks), and 1-year follow-up
Secondary	Change from baseline in working memory as measured with the digits forward and backward test at 8 weeks and 1-year follow-up	Measured by Standard Neuropsychological Tests and the NIH Toolbox	Measured at baseline and at program completion (8 weeks), and 1-year follow-up
Secondary	Change from baseline in functional capacity as measured by the 6-Minute Walk Test at 8 weeks and 1-year follow-up	Measured by the 6-Minute Walk Test	Measured at baseline and at program completion (8 weeks), and 1-year follow-up
Secondary	Change from baseline in mobility as measured by the Short Physical Performance Battery (SPPB) at 8 weeks	Measured by the Short Physical Performance Battery	Measured at baseline and at program completion (8 weeks).
Secondary	Change from baseline in brain structure as measured by structural MRI at 8 weeks	Measured by structural MRI	Measured at baseline and at program completion (8 weeks).
Secondary	Change from baseline in brain function as measured by resting state functional MRI at 8 weeks	Measured by resting state functional MRI	Measured at baseline and at program completion (8 weeks).