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Mild Cognitive ImpairmentNCT02564809

Cognitive Brain Training in Older Adults

A study testing Fit Brains Training, Exercise + Fit Brains Training and Balanced And Tone in people with Mild Cognitive Impairment, run by University of British Columbia at 1 site in Canada.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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. Read more about this study

Who is it for?
Ages 65 to 85 yearsHealthy volunteers can take part
Conditions the study is for
Mild Cognitive Impairment
What is being tested?
Fit Brains Training, Exercise + Fit Brains Training and Balanced And Tone
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
123 participants
Where
1 siteCanada
Study dates
Jan 2016to Sep 2018
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 65 to 85 years
  • All sexes
  • Healthy volunteers accepted
  • Older adult

Who may be able to join

  • 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
Show all 10Show fewer
  • 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.

Who cannot join

  • 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.

Trial locations and contacts

1 site in 1 country.

Canada1 site
  • Djavad Mowafaghian Centre for Brain Health & Centre for Hip Health and Mobility

    Vancouver, British Columbia, V6T 1Z3

Other trials in Canada

About this study

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

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).

Read the 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.

Being tested
Fit Brains Training, Exercise + Fit Brains Training, Balanced And Tone
Medical subject headings
Cognitive Dysfunction

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Fit Brains TrainingBehavioural

    Also called FBT

    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 TrainingBehavioural

    Also called Ex-FBT

    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 ToneBehavioural

    Also called BAT

    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.

Study groups in NCT02564809
Study groupRoleWhat they receive
Fit Brains trainingExperimentalBoth 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.
Receives: Behavioral: Fit Brains Training
Exercise + Fit Brains trainingExperimentalBoth 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.
Receives: Behavioral: Exercise + Fit Brains Training
Balanced And ToneSham comparatorBoth healthy participants and participants with Mild Cognitive Impairment (MCI) will complete 3 weekly training sessions of 1 hour for 8 weeks.
Receives: Behavioral: Balanced And Tone

What is being measured

The primary outcome is the main question the study is designed to answer.

  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: Measured at baseline and at program completion (8 weeks), and 1-year follow-up

Secondary outcomes (7)
  1. 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: Measured at baseline and at program completion (8 weeks), and 1-year follow-up

  2. 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: Measured at baseline and at program completion (8 weeks), and 1-year follow-up

  3. 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: Measured at baseline and at program completion (8 weeks), and 1-year follow-up

  4. 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: Measured at baseline and at program completion (8 weeks), and 1-year follow-up

  5. 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: Measured at baseline and at program completion (8 weeks).

  6. Change from baseline in brain structure as measured by structural MRI at 8 weeks

    Measured by structural MRI

    Measured: Measured at baseline and at program completion (8 weeks).

  7. Change from baseline in brain function as measured by resting state functional MRI at 8 weeks

    Measured by resting state functional MRI

    Measured: Measured at baseline and at program completion (8 weeks).

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted1 Oct 2015 (estimated)
  2. Study startJan 2016
  3. Primary completionSep 2018
  4. Study completionSep 2018

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Outcomes assessor
Enrolment
123 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02564809
Sponsor's protocol ID
H14-02438
Status last verified
May 2019
First submitted
1 Sep 2015
Last updated
9 May 2019
Results posted
No
Data monitoring committee
Yes

Publications

  • 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.

    PubMed 29378515

Questions about this trial

What is this clinical trial studying?

A study testing Fit Brains Training, Exercise + Fit Brains Training and Balanced And Tone in people with Mild Cognitive Impairment, run by University of British Columbia at 1 site in Canada.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 10 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 9 May 2019. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change from baseline in episodic memory as measured with the Rey Auditory Verbal Learning Test (RAVLT) at 8 weeks and 1-year follow-up (time frame: Measured at baseline and at program completion (8 weeks), and 1-year follow-up). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02564809, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 May 2019.

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Cognitive Brain Training in Older Adults (NCT02564809) | AzTrials