Can brain training lead to short term and sustained improvements in cognitive function?

ISRCTN	ISRCTN72895114
DOI	https://doi.org/10.1186/ISRCTN72895114
Secondary identifying numbers	Protocol version 9 21/05/09

Submission date: 21/05/2009
Registration date: 18/09/2009
Last edited: 07/08/2020

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Nervous System Diseases

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English summary of protocol

Not provided at time of registration

Contact information

Prof Clive Ballard
Scientific

Wolfson Centre for Age-Related Diseases
King's College London
Guy's Campus
London
SE1 1UL
United Kingdom

Email	clive.ballard@kcl.ac.uk

Study information

Study design	Randomised single-blind three-armed controlled trial
Primary study design	Interventional
Secondary study design	Randomised controlled trial
Study setting(s)	Not specified
Study type	Treatment
Participant information sheet	Not available in web format, please use the contact details below to request a patient information sheet
Scientific title	A randomised single-blind three-armed controlled trial comparing evidence-based reasoning brain training (RBT), general brain training (GBT) and a control treatment to determine short term and sustained improvements in cognitive function
Study acronym	BrainTrain
Study objectives	Study 1: All adults Primary hypothesis: 1. In adults of all ages, there will be significant improvements in global cognition measured by a composite cognitive score in people allocated to RBT compared to those allocated to control after 6 weeks and 12 months of brain training. Secondary hypotheses: 1. There will significant improvements in fluid intelligence and other aspects of cognition including attention, memory and working memory in people allocated to RBT compared to those allocated to the control treatment after 6 weeks or 12 months of training 2. There will no significant improvements in cognitive outcomes in people allocated to GBT compared to those allocated to the control treatment after 6 weeks or 12 months of training 3. There will significant improvements in a broad range of cognitive outcomes and a composite cognitive score and specifically in fluid intelligence and reasoning in people allocated to RBT compared to those allocated to the GBT treatment after 6 weeks or 12 months of training Study 2: Adults aged greater than 60 years Primary hypothesis: 1. In people over the age of 60, instrumental activites of daily living (IADL) will be significantly improved in people allocated to RBT compared to those allocated to a control treatment after 12 months of brain training. Secondary hypotheses: 1. In people with age-associated cognitive decline (AACD), there will be significant improvement in a broad range of cognitive outcomes, a composite cognitive score and IADL in people allocated to RBT compared to those allocated to the control treatment over 12 months of brain training 2. There will significant improvements in attention, memory, working memory, fluid intelligence and a composite cognitive score in people over 60 allocated to RBT compared to those allocated to the control treatment after 6 weeks or 12 months of training 3. There will no significant improvements in cognitive outcomes in people over 60 allocated to GBT compared to those allocated to the control treatment after 6 weeks or 12 months of training 4. There will significant improvements in a broad range of cognitive outcomes and a composite cognitive score in people over 60 allocated to RBT compared to those allocated to the GBT treatment after 6 weeks or 12 months of training
Ethics approval(s)	Not provided at time of registration
Health condition(s) or problem(s) studied	Dementia prevention
Intervention	1. RBT will focus upon tasks related to reasoning and problem solving. In the Willis et al (2006) study, which provides the best evidence base for sustained benefit, reasoning training was the only brain training that conferred generalised benefits on other aspects of cognition and everyday activities. The recommendation is for participants to complete the training for 10 minutes every day, although with flexibility to do more or less than the recommended amount. An initial feasibility pilot of the brain training package has been completed on 22 older individuals which has been very well received and enabled minor presentational issues to be addressed. 2. GBT will cover a range of cognitive tests other than reasoning/problem solving found in commercial brain training games. Again the recommendation is for participants to complete the training for 10 minutes every day. 3. Control: the control group will perform an internet search based task every day.
Intervention type	Other
Primary outcome measure	1. Overall performance on cognitive tasks (composite score) at 6 weeks and 12 months in all participants comparing RBT and dummy/placebo treatment 2. Everyday activities at 12 months in participants over 60 comparing RBT and dummy/placebo treatment
Secondary outcome measures	1. All participants: Cognitive test battery including: 1.1. Memory 1.2. Working memory 1.3. Speed 1.4. Fluid intelligence 1.5. Executive function: 1.5.1. Paired Associate Learning task 1.5.2. Spatial Working Memory 1.5.3. Digit span 1.5.4. Grammatical reasoning 2. Participants over 60 years old: 2.1. Hopkins verbal learning test (HVLT - recognition subscale) 2.2. Self-reported assessment of Instrumental Activities of Daily Living (IADL) from the Minimum Data-set Home Care scale
Overall study start date	01/01/2010
Completion date	01/01/2012

Eligibility

Participant type(s)	Patient
Age group	Other
Sex	Both
Target number of participants	75000 - 100000
Total final enrolment	52617
Key inclusion criteria	As part of an exciting partnership between the BBC and the Alzheimer's Society, the BBC will invite all adults in the UK and internationally to take part in a randomised controlled trial (RCT) of brain training. It is anticipated that between 75,000 and 100,000 participants will take part. The population will be analysed as two separate studies: 1. All adults, either sex 2. Adults aged greater than 60 years, either sex
Key exclusion criteria	1. Aged less than 20 years 2. Dementia 3. Not living in UK
Date of first enrolment	01/01/2010
Date of final enrolment	01/01/2012

Locations

Countries of recruitment

England
United Kingdom

Study participating centre

Wolfson Centre for Age-Related Diseases

London
SE1 1UL
United Kingdom

Sponsor information

King's College London (UK)
University/education

Guy's Campus
London
SE1 1UL
England
United Kingdom

Email	clive.ballard@kcl.ac.uk
Website	http://www.kcl.ac.uk
"ROR"	https://ror.org/0220mzb33

Funders

Funder type

Charity

British Broadcasting Corporation (BBC) (UK)

No information available

Alzheimer's Society (UK)
Private sector organisation / Associations and societies (private and public)

Alternative name(s): alzheimerssoc
Location: United Kingdom

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
Publication and dissemination plan	Not provided at time of registration
IPD sharing plan

Study outputs

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Results article	results	01/06/2010	07/08/2020	Yes	No
Results article	results	01/11/2015	07/08/2020	Yes	No

Editorial Notes

07/08/2020: The following changes were made to the trial record:
1. Publication reference added.
2. The total final enrolment was added.
12/04/2017: No publications found in PubMed, verifying study status with principal investigator.