Cognitive Brain Training in Older Adults

NCT ID: NCT02564809

Last Updated: 2019-05-09

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 123 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-01-31
• Study Completion Date: 2018-09-30

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.

Conditions

Mild Cognitive Impairment

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: SINGLE

Study Groups

Fit Brains training

Both healthy participants and participants with Mild Cognitive Impairment (MCI) will be performing a cognitive training program (Fit Brains training) 6 hours a week for 8 weeks.

Group Type: EXPERIMENTAL

Fit Brains Training

Intervention Type: BEHAVIORAL

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

Both healthy participants and participants with Mild Cognitive Impairment (MCI) will be performing a combination of aerobic exercise and a cognitive training program (Fit Brains training) for 6 hours a week over 8 weeks.

Group Type: EXPERIMENTAL

Exercise + Fit Brains Training

Intervention Type: BEHAVIORAL

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

Both healthy participants and participants with Mild Cognitive Impairment (MCI) will complete 3 weekly training sessions of 1 hour for 8 weeks.

Group Type: SHAM_COMPARATOR

Balanced And Tone

Intervention Type: BEHAVIORAL

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.

Interventions

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.

Intervention Type: BEHAVIORAL

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.

Intervention Type: BEHAVIORAL

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.

Intervention Type: BEHAVIORAL

Other Intervention Names

FBT; Ex-FBT; BAT

Eligibility Criteria

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

• 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.

• Minimum Eligible Age: 65 Years
• Maximum Eligible Age: 85 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Mitacs

INDUSTRY

Sponsor Role: collaborator

University of British Columbia

OTHER

Sponsor Role: lead

Responsible Party

Teresa Liu-Ambrose

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Teresa Liu-Ambrose, PhD

Role: PRINCIPAL_INVESTIGATOR

University of British Columbia

John R Best, PhD

Role: PRINCIPAL_INVESTIGATOR

University of British Columbia

Lindsay S Nagamatsu, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Western Ontario, Canada

Lisanne F ten Brinke, MSc

Role: PRINCIPAL_INVESTIGATOR

University of British Columbia

Conny Lin, MsC

Role: PRINCIPAL_INVESTIGATOR

Rosetta Stone Canada

Locations

Djavad Mowafaghian Centre for Brain Health & Centre for Hip Health and Mobility

Vancouver, British Columbia, Canada

Countries

Canada

References

Ten Brinke LF, Best JR, Crockett RA, Liu-Ambrose T. The effects of an 8-week computerized cognitive training program in older adults: a study protocol for a randomized controlled trial. BMC Geriatr. 2018 Jan 30;18(1):31. doi: 10.1186/s12877-018-0730-6.

Reference Type: DERIVED

PMID: 29378515 (View on PubMed)

Other Identifiers

H14-02438

Identifier Type: -

Identifier Source: org_study_id