Cognitive Brain Training in Older Adults
Condition: Mild Cognitive Impairment
MeSH terms: Cognitive Dysfunction
Study type: Interventional

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.
    

Intervention name(s): Fit Brains Training; Exercise + Fit Brains Training; Balanced And Tone
Intervention type(s): Behavioral; Behavioral; Behavioral
Intervention description(s): 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.; 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.; 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.
Other intervention name(s): FBT; Ex-FBT; BAT
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Prevention