The Active Brains study - feasibility trial

Not Applicable

Completed

• Conditions: Cognitive decline; Mental and Behavioural Disorders; Other and unspecified symptoms and signs involving cognitive functions and awareness

• Registration Number: ISRCTN23758980
• Lead Sponsor: niversity of Southampton

Brief Summary

2020 Protocol article in https://pubmed.ncbi.nlm.nih.gov/33216010/ protocol (added 23/11/2020) 2022 Results article in https://pubmed.ncbi.nlm.nih.gov/36203694/ (added 06/09/2023)

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2018-08-01
• Study Completion: 2020-03-21
• Last Update Posted: 18 September 2023

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 20000

Inclusion Criteria

Participant inclusion criteria as of 11/10/2018:
Cognitively impaired participants:
1. Aged between 60 and 85 years old
2. Have cognitive impairment: 1 SD below the norm for the Baddeley reasoning test. We will explore the impact in subgroups defined by combinations of impairment in Baddeley reasoning, IADL and memory. Key subgroups for those with cognitive impairment that are of particular interest are:
2.1. AACD: 1SD below norm for an average of 3 tests for Baddeley reasoning + 1sd below norm for Instrumental activities of Daily Living (IADL)
2.2. MCI: 1.5SD below norm for an average of 3 tests for Baddeley reasoning + 1.5 SD below norm for an average of 3 tests for impaired memory (self-ordered search test)
3. Be willing and able to access the internet

Non-Cognitively impaired participants:
To be eligible for inclusion individuals without signs of cognitive decline will:
1. Be aged between 60 and 85 years old
2. Have normal cognitive function (i.e. do not meet criteria for inclusion in the cognitively impaired trial)
3. Be willing and able to access the internet

Previous participant inclusion criteria:
To be eligible for inclusion, individuals with signs of cognitive decline will:
1. Be aged between 60 and 85 years old
2. Have either MCI (defined as 1.5 SD below the norm in a non-memory cognitive domain plus memory impairment or AACD (defined as 1 SD below the norm for the Baddeley reasoning test)
3. Be willing and able to access the internet

To be eligible for inclusion individuals without signs of cognitive decline will:
1. Be aged between 60 and 85 years old
2. Have normal cognitive function (i.e. do not meet criteria for MCI or AACD)
3. Be willing and able to access the internet

Exclusion Criteria

1. Have an existing diagnosis of dementia
2. Report high levels of leisure time physical activity already (i.e. score 30 or more on the Godin Leisure Time Exercise Questionnaire (counting moderate or vigorous physical activity only))
3. Do not have access to the internet

Individuals without signs of cognitive decline will be excluded if:
1. In full time employment (or are fully retired)
2. Have an existing diagnosis of dementia
3. Report high levels of leisure time physical activity already (i.e. score 30 or more on the Godin Leisure Time Exercise Questionnaire (counting moderate or vigorous physical activity only))
4. Do not have access to the internet

Study & Design

• Study Type: Interventional
• Study Design: Not specified