search
Back to results

Cognitive Brain Training in Older Adults

Primary Purpose

Mild Cognitive Impairment

Status
Completed
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
Fit Brains Training
Exercise + Fit Brains Training
Balanced And Tone
Sponsored by
University of British Columbia
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Mild Cognitive Impairment

Eligibility Criteria

65 Years - 85 Years (Older Adult)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

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

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Sham Comparator

Arm Label

Fit Brains training

Exercise + Fit Brains training

Balanced And Tone

Arm Description

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.

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.

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

Outcomes

Primary Outcome Measures

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)

Secondary Outcome Measures

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
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
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
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
Change from baseline in mobility as measured by the Short Physical Performance Battery (SPPB) at 8 weeks
Measured by the Short Physical Performance Battery
Change from baseline in brain structure as measured by structural MRI at 8 weeks
Measured by structural MRI
Change from baseline in brain function as measured by resting state functional MRI at 8 weeks
Measured by resting state functional MRI

Full Information

First Posted
September 1, 2015
Last Updated
May 7, 2019
Sponsor
University of British Columbia
Collaborators
Mitacs
search

1. Study Identification

Unique Protocol Identification Number
NCT02564809
Brief Title
Cognitive Brain Training in Older Adults
Official Title
The Effect of Fit Brains Training on Cognitive Performance in Older Adults
Study Type
Interventional

2. Study Status

Record Verification Date
May 2019
Overall Recruitment Status
Completed
Study Start Date
January 2016 (undefined)
Primary Completion Date
September 2018 (Actual)
Study Completion Date
September 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of British Columbia
Collaborators
Mitacs

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Mild Cognitive Impairment

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
123 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Fit Brains training
Arm Type
Experimental
Arm Description
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.
Arm Title
Exercise + Fit Brains training
Arm Type
Experimental
Arm Description
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.
Arm Title
Balanced And Tone
Arm Type
Sham Comparator
Arm Description
Both healthy participants and participants with Mild Cognitive Impairment (MCI) will complete 3 weekly training sessions of 1 hour for 8 weeks.
Intervention Type
Behavioral
Intervention Name(s)
Fit Brains Training
Other Intervention Name(s)
FBT
Intervention Description
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
Intervention Name(s)
Exercise + Fit Brains Training
Other Intervention Name(s)
Ex-FBT
Intervention Description
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
Intervention Name(s)
Balanced And Tone
Other Intervention Name(s)
BAT
Intervention Description
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.
Primary Outcome Measure Information:
Title
Change from baseline in episodic memory as measured with the Rey Auditory Verbal Learning Test (RAVLT) at 8 weeks and 1-year follow-up
Description
Measured by the Rey Auditory Verbal Learning Test (RAVLT)
Time Frame
Measured at baseline and at program completion (8 weeks), and 1-year follow-up
Secondary Outcome Measure Information:
Title
Change from baseline in response inhibition as measured with the stroop test at 8 weeks and 1-year follow-up
Description
Measured by Standard Neuropsychological Tests and the NIH Toolbox
Time Frame
Measured at baseline and at program completion (8 weeks), and 1-year follow-up
Title
Change from baseline in set shifting as measured with the Trailmaking A and B test at 8 weeks and 1-year follow-up
Description
Measured by Standard Neuropsychological Tests and the NIH Toolbox
Time Frame
Measured at baseline and at program completion (8 weeks), and 1-year follow-up
Title
Change from baseline in working memory as measured with the digits forward and backward test at 8 weeks and 1-year follow-up
Description
Measured by Standard Neuropsychological Tests and the NIH Toolbox
Time Frame
Measured at baseline and at program completion (8 weeks), and 1-year follow-up
Title
Change from baseline in functional capacity as measured by the 6-Minute Walk Test at 8 weeks and 1-year follow-up
Description
Measured by the 6-Minute Walk Test
Time Frame
Measured at baseline and at program completion (8 weeks), and 1-year follow-up
Title
Change from baseline in mobility as measured by the Short Physical Performance Battery (SPPB) at 8 weeks
Description
Measured by the Short Physical Performance Battery
Time Frame
Measured at baseline and at program completion (8 weeks).
Title
Change from baseline in brain structure as measured by structural MRI at 8 weeks
Description
Measured by structural MRI
Time Frame
Measured at baseline and at program completion (8 weeks).
Title
Change from baseline in brain function as measured by resting state functional MRI at 8 weeks
Description
Measured by resting state functional MRI
Time Frame
Measured at baseline and at program completion (8 weeks).

10. Eligibility

Sex
All
Minimum Age & Unit of Time
65 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Teresa Liu-Ambrose, PhD
Organizational Affiliation
University of British Columbia
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
John R Best, PhD
Organizational Affiliation
University of British Columbia
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Lindsay S Nagamatsu, PhD
Organizational Affiliation
University of Western Ontario, Canada
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Lisanne F ten Brinke, MSc
Organizational Affiliation
University of British Columbia
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Conny Lin, MsC
Organizational Affiliation
Rosetta Stone Canada
Official's Role
Principal Investigator
Facility Information:
Facility Name
Djavad Mowafaghian Centre for Brain Health & Centre for Hip Health and Mobility
City
Vancouver
State/Province
British Columbia
ZIP/Postal Code
V6T 1Z3
Country
Canada

12. IPD Sharing Statement

Citations:
PubMed Identifier
29378515
Citation
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.
Results Reference
derived

Learn more about this trial

Cognitive Brain Training in Older Adults

We'll reach out to this number within 24 hrs