Online Grammatical Reasoning Training for Older Adults

Healthy Aging Clinical Trial

— START  

Official title:

Impact of Short-term Intensive Online Grammatical Reasoning Training on Cognition and Function in Adults Over 50: An Online Randomised Controlled Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03661190
• Other study ID #: 216941
• Status: Completed
• Phase: N/A
• Start date: March 31, 2017
• Est. completion date: November 30, 2018

Study information

• Verified date: April 2019
• Source: University of Exeter
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The START study will investigate the impact of playing a Grammatical Reasoning brain training task on overall brain function (cognition) and day-to-day function in people over 50.

The study builds on existing work that has shown very promising results with brain training approaches in older adults. There is good evidence that playing brain training games leads to improvements in brain functions including memory and reasoning. There is also a suggestion that regular involvement in brain training games might help reduce the risk of cognitive decline and dementia later in life. It appears that reasoning, or problem-solving, is particularly important as it is one of the first abilities to decline with age. This study will use this evidence to target reasoning in a specific brain training task. It will also explore the potential role of genetic factors in how people perform in the task.

The study will compare the impact of a Grammatical Reasoning Task (START) with a control task consisting of simple picture-matching. Over 7000 participants will be randomly allocated to either START or the control and will be asked to play the task as often as they wish for a period of six weeks. Both tasks will be delivered entirely online so people will access the study from home on their computers. This will be achieved through our dedicated online research platform, PROTECT, which hosts a cohort of over 20,000 older adults who have provided DNA samples as part of a longitudinal study.

This study will measure the impact of the training on cognition and Instrumental Activities of Daily Living. Assessments will be completed online at baseline, two/six weeks and six months. Overall, this study aims to generate exciting new data about how brain training could be included in guidance on healthy ageing.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 7240
• Est. completion date: November 30, 2018
• Est. primary completion date: May 31, 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 50 Years to 100 Years

Eligibility

Inclusion Criteria:

• Adults over 50

• Access to a computer with a keyboard and the internet

• Participant registered on the PROTECT study

Exclusion Criteria:

• Diagnosis of dementia

Related Conditions & MeSH terms

• Healthy Aging

Intervention

Other:
• Grammatical Reasoning
START measures the ability to determine the relationships among different shape combinations which are assigned to grammatical statements about them which can be either correct or incorrect. It is a measure of attention, working memory and executive control.
• Card Pairs
A basic picture-matching task.

Locations

Country	Name	City	State
United Kingdom	University of Exeter Medical School	Exeter

Sponsors (4)

Lead Sponsor	Collaborator
University of Exeter	King's College London, South London and Maudsley NHS Foundation Trust, Wesnes Cognition Ltd

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	A composite measure of cognitive function	The primary outcome measure will be a composite measure of cognitive function, created through a combined score of each of the measures described below. The individual measures will be included as discrete secondary outcome measures. All outcome measures will be completed online. They are sensitive to change in cognition, and validated for use in older adults to detect early changes in cognition.	Participants will be directed to complete these measures at baseline, two/ six weeks and six months
Secondary	Executive function	Measured by a test of visual attention, the Trail making B, which is a validated measure for use in this population.	Baseline, two weeks, six weeks and 6 months
Secondary	Executive function	Measured by a test of task-switching, the Switching Stroop Test, which is a validated measure for use in this population.	Baseline, two weeks, six weeks and 6 months
Secondary	Cognitive function	Measured through the Baddeley Logical Reasoning Task (letter sequence)11 - part of the Wesnes Cognition Ltd CogTrackTM system.	Baseline, two weeks, six weeks and 6 months
Secondary	Cognitive function	Measured through a Digit Vigilance test as part of the Wesnes Cognition Ltd CogTrackTM system.	Baseline, two weeks, six weeks and 6 months
Secondary	Cognitive function	Measured through a Simple and Choice Reaction time test as part of the Wesnes Cognition Ltd CogTrackTM system.	Baseline, two weeks, six weeks and 6 months
Secondary	Cognitive function	Measured through a Spatial Working Memory test as part of the Wesnes Cognition Ltd CogTrackTM system.	Baseline, two weeks, six weeks and 6 months
Secondary	Cognitive function	Measured through a Numeric Working Memory test as part of the Wesnes Cognition Ltd CogTrackTM system.	Baseline, two weeks, six weeks and 6 months
Secondary	Cognitive function	Measured through a Pattern Separation test as part of the Wesnes Cognition Ltd CogTrackTM system.	Baseline, two weeks, six weeks and 6 months
Secondary	Cognitive function	Measured through a Word Recall (delayed and immediate) test as part of the Wesnes Cognition Ltd CogTrackTM system.	Baseline, two weeks, six weeks and 6 months
Secondary	Cognitive function	Measured through a Word Recognition test as part of the Wesnes Cognition Ltd CogTrackTM system.	Baseline, two weeks, six weeks and 6 months
Secondary	Verbal Learning	Measured through the validated Paired Associate Learning measure, which is highly sensitive to change in cognition and has been used to predict conversion to Alzheimer's Disease in people with cognitive impairment.	Baseline, two weeks, six weeks and 6 months
Secondary	Instrumental Activities of Daily Living (IADL)	Measured by the modified Instrumental Activities of Daily Living measure which is validated for use in this population, and has been successfully used to show change in IADL in previous online brain training studies.	Baseline, two weeks, six weeks and 6 months
Secondary	Use of cognitive training	Participants will complete a brief question regarding their use of cognitive training (computer games, crosswords, Sudoku etc) and the regularity of use	6 months