Cognitive Brain Training in Older Adults

NCT02564809 | Completed DMC

• 1 other identifier: H14-02438
• Study Type: interventional
• Target: 123
• Locations: 1 country
• Sites: 1

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).

Conditions

Mild Cognitive Impairment

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (7)

• 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

• 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

• 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

• 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

• 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).

Study Arms (3)

Fit Brains training

EXPERIMENTAL

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.

Behavioral: Fit Brains Training

Exercise + Fit Brains training

EXPERIMENTAL

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.

Behavioral: Exercise + Fit Brains Training

Balanced And Tone

SHAM COMPARATOR

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

Behavioral: Balanced And Tone

Interventions

Fit Brains Training 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.

Also known as: FBT

Fit Brains training

Exercise + Fit Brains Training 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.

Also known as: Ex-FBT

Exercise + Fit Brains training

Balanced And Tone 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.

Also known as: BAT

Balanced And Tone

Eligibility Criteria

• Age: 65 Years - 85 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of British Columbia: lead
• Mitacs: collaborator

Study Sites (1)

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

Vancouver, British Columbia, V6T 1Z3, Canada

Location

Related Publications (1)

• 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.

  PMID: 29378515 DERIVED

MeSH Terms

Conditions

Cognitive Dysfunction

Interventions

Exercise

Condition Hierarchy (Ancestors)

Cognition Disorders; Neurocognitive Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Study Officials

• Teresa Liu-Ambrose, PhD

  University of British Columbia

  PRINCIPAL INVESTIGATOR

• John R Best, PhD

  University of British Columbia

  PRINCIPAL INVESTIGATOR

• Lindsay S Nagamatsu, PhD

  University of Western Ontario, Canada

  PRINCIPAL INVESTIGATOR

• Lisanne F ten Brinke, MSc

  University of British Columbia

  PRINCIPAL INVESTIGATOR

• Conny Lin, MsC

  Rosetta Stone Canada

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: September 1, 2015
• First Posted: October 1, 2015
• Study Start: January 1, 2016
• Primary Completion: September 1, 2018
• Study Completion: September 1, 2018
• Last Updated: May 9, 2019

Record last verified: 2019-05

Locations

CA (1)