Cognitive AgingPASOCANCT05455229
Elucidating How Physical Activity and Sleep Relate to Optimal Cognitive Ageing
An observational study of Cognitive Aging, run by KU Leuven at 1 site in Belgium.
Trial summary
Increased longevity is one of the greatest success stories in public health. However, ageing is accompanied by cognitive decline which affects people's daily functioning and, if it develops to dementia, their ability to live independently. By 2050, the number of people who develop dementia will triple to 152 million. Read more about this study
- Who is it for?
- Ages 55 years and olderHealthy volunteers can take part
- Conditions the study is for
- Cognitive Aging
- How many people
- 260 participants
- Where
- 1 siteBelgium
- Study dates
- 22 Jul 2021to 31 Mar 2024
- Phase
- Observational
- 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 55 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Community dwelling, healthy adults aged 55 and above living in Belgium.
Who may be able to join
- Community dwelling, healthy adults aged 55 and above
Who cannot join
- has a neurodegenerative disease such as Parkinson's, Alzheimer's, MS…; or
- has a psychiatric illness such as bipolar disorder, OCD…; or
- has had a serious brain injury in the past year or before that is still affecting them; or
- has had a brain haemorrhage; or
- is currently experiencing a depressive episode; or
- has a history of addiction or excessive alcohol abuse; or
Show all 11Show fewer
- uses a sleeping device (for sleep apnoea); or
- has chronic insomnia (diagnosed insomnia); or
- is severely limited in performing daily activities (up and down stairs, walk ...)
- has a first-degree dementia within the family
- scores a 23 or lower on the Montreal Cognitive Assessment
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Elucidating How Physical Activity and Sleep Relate to Optimal Cognitive Ageing: the PASOCA- Study
Increased longevity is one of the greatest success stories in public health. However, ageing is accompanied by cognitive decline which affects people's daily functioning and, if it develops to dementia, their ability to live independently. By 2050, the number of people who develop dementia will triple to 152 million. The aim of this project is to precisely examine how physical activity (PA) and sleep, both modifiable lifestyle factors, are related to cognitive function and which role they can play in optimal cognitive ageing. To do so, a longitudinal study will be conducted, with objective measures of PA, sleep and cognition in midlife and older adults. This project will meet the current need for longitudinal studies with objective PA and sleep data, as well as provide, for the first time, in-depth information on associations of type of PA (aerobic vs muscle strengthening), characteristics of sleep (quality vs quantity) with specific cognitive domains (executive function and memory). Furthermore, although PA and sleep are related, the behavioural dynamics of combinations of PA and sleep on cognition has never been studied before. To fill this gap, these relationships will be examined with an innovative statistical approach, looking at data across a 24-hour period. The resulting deeper understanding of the precise relationship between PA, sleep and cognitive function will contribute to the development of preventive interventions for maintaining cognitive health at older age.
- Conditions
- Cognitive Aging
- Keywords
- Physical activity, Sedentary behaviour, Sleep, Cognition, Ageing, Longitudinal, Observational, Accelerometry
- Medical subject headings
- Motor Activity
What is being measured
The primary outcome is the main question the study is designed to answer.
Cognitive function (baseline) - objective: executive function and memory will be tested with Cambridge Neuropsychological Test Automated Battery (CANTAB)
Executive functions and memory will be the main outcome measure for cognitive function. Executive control (planning, shifting, inhibiting, attention) and memory (visuospatial, episodic, verbal) functions will be measured objectively using an iPad with the validated CANTAB software (cambridgecognition.com). Specific tasks in the test battery:
- Practice: MOT (Motor Screening Task)
- Memory: PAL (Paired Associates Learning), DMS (Delayed Matching to Sample), VRM (Verbal Recognition Memory)
- Executive control: MTT Multitasking Test, OTS (One Touch Stockings of Cambridge), SWM (Spatial Working Memory)
Measured: baseline
Change in cognitive function (follow up 1) - objective: executive function and memory will be tested with Cambridge Neuropsychological Test Automated Battery (CANTAB)
Executive functions and memory will be the main outcome measure for cognitive function. Executive control (planning, shifting, inhibiting, attention) and memory (visuospatial, episodic, verbal) functions will be measured objectively using an iPad with the validated CANTAB software (cambridgecognition.com). Specific tasks in the test battery:
- Practice: MOT (Motor Screening Task)
- Memory: PAL (Paired Associates Learning), DMS (Delayed Matching to Sample), VRM (Verbal Recognition Memory)
- Executive control: MTT Multitasking Test, OTS (One Touch Stockings of Cambridge), SWM (Spatial Working Memory)
Measured: 1 year after baseline
Change in cognitive function (follow up 2) - objective: executive function and memory will be tested with Cambridge Neuropsychological Test Automated Battery (CANTAB)
Executive functions and memory will be the main outcome measure for cognitive function. Executive control (planning, shifting, inhibiting, attention) and memory (visuospatial, episodic, verbal) functions will be measured objectively using an iPad with the validated CANTAB software (cambridgecognition.com). Specific tasks in the test battery:
- Practice: MOT (Motor Screening Task)
- Memory: PAL (Paired Associates Learning), DMS (Delayed Matching to Sample), VRM (Verbal Recognition Memory)
- Executive control: MTT Multitasking Test, OTS (One Touch Stockings of Cambridge), SWM (Spatial Working Memory)
Measured: 1 year after follow up 1; 2 years after baseline
Cognitive function (baseline) - subjective: Cognitive Failure Questionnaire
25-items will be used to measure subjective cognitive decline by assessing self-reported frequency of failures in several cognitive domains.
Measured: baseline
Change in cognitive function (follow up 1) - subjective: Cognitive Failure Questionnaire
25-items will be used to measure subjective cognitive decline by assessing self-reported frequency of failures in several cognitive domains.
Measured: 1 year after baseline
Change in cognitive function (follow up 2) - subjective: Cognitive Failure Questionnaire
25-items will be used to measure subjective cognitive decline by assessing self-reported frequency of failures in several cognitive domains.
Measured: 1 year after follow up 1; 2 years after baseline
Sleep (baseline) - objective: accelerometery - characteristic 1: total sleep time
Specifically ActiGraph's wGT3X-BT Activity Monitor (ActiGraph, Pensacola, FL). Placement at the wrist results in the increased wear time and accuracy of sleep measurement. Total sleep time is measured in minutes.
Measured: baseline
Sleep (baseline) - objective: accelerometery - characteristic 2: wake after sleep onset
Specifically ActiGraph's wGT3X-BT Activity Monitor (ActiGraph, Pensacola, FL). Placement at the wrist results in the increased wear time and accuracy of sleep measurement. Wake after sleep onset is measured in minutes.
Measured: baseline
Sleep (baseline) - objective: accelerometery - characteristic 3: sleep efficiency
Specifically ActiGraph's wGT3X-BT Activity Monitor (ActiGraph, Pensacola, FL). Placement at the wrist results in the increased wear time and accuracy of sleep measurement. Sleep efficiency is displayed in percentage.
Measured: baseline
Sleep (baseline) - objective: accelerometery - characteristic 4: sleep latency
Specifically ActiGraph's wGT3X-BT Activity Monitor (ActiGraph, Pensacola, FL). Placement at the wrist results in the increased wear time and accuracy of sleep measurement. Sleep latency is measured in minutes.
Measured: baseline
Change in sleep (follow up 1) - objective: accelerometery - characteristic 1: total sleep time
Specifically ActiGraph's wGT3X-BT Activity Monitor (ActiGraph, Pensacola, FL). Placement at the wrist results in the increased wear time and accuracy of sleep measurement. Total sleep time is measured in minutes.
Measured: 1 year after baseline
Change in sleep (follow up 1) - objective: accelerometery - characteristic 2: wake after sleep onset
Specifically ActiGraph's wGT3X-BT Activity Monitor (ActiGraph, Pensacola, FL). Placement at the wrist results in the increased wear time and accuracy of sleep measurement. Wake after sleep onset is measured in minutes.
Measured: 1 year after baseline
Change in sleep (follow up 1) - objective: accelerometery - characteristic 3: sleep efficiency
Specifically ActiGraph's wGT3X-BT Activity Monitor (ActiGraph, Pensacola, FL). Placement at the wrist results in the increased wear time and accuracy of sleep measurement. Sleep efficiency is displayed in percentage.
Measured: 1 year after baseline
Change in sleep (follow up 1) - objective: accelerometery - characteristic 4: sleep latency
Specifically ActiGraph's wGT3X-BT Activity Monitor (ActiGraph, Pensacola, FL). Placement at the wrist results in the increased wear time and accuracy of sleep measurement. Sleep latency is measured in minutes.
Measured: 1 year after baseline
Change in sleep (follow up 2) - objective: accelerometery - characteristic 1: total sleep time
Specifically ActiGraph's wGT3X-BT Activity Monitor (ActiGraph, Pensacola, FL). Placement at the wrist results in the increased wear time and accuracy of sleep measurement. Total sleep time is measured in minutes.
Measured: 1 year after follow up 1; 2 years after baseline
Change in sleep (follow up 2) - objective: accelerometery - characteristic 2: wake after
Specifically ActiGraph's wGT3X-BT Activity Monitor (ActiGraph, Pensacola, FL). Placement at the wrist results in the increased wear time and accuracy of sleep measurement. Wake after sleep onset is measured in minutes.
Measured: 1 year after follow up 1; 2 years after baseline
Change in sleep (follow up 2) - objective: accelerometery - characteristic 3: sleep efficiency
Specifically ActiGraph's wGT3X-BT Activity Monitor (ActiGraph, Pensacola, FL). Placement at the wrist results in the increased wear time and accuracy of sleep measurement. Sleep efficiency is displayed in percentage.
Measured: 1 year after follow up 1; 2 years after baseline
Change in sleep (follow up 2) - objective: accelerometery - characteristic 4: sleep latency
Specifically ActiGraph's wGT3X-BT Activity Monitor (ActiGraph, Pensacola, FL). Placement at the wrist results in the increased wear time and accuracy of sleep measurement. Sleep latency is measured in minutes.
Measured: 1 year after follow up 1; 2 years after baseline
Sleep (baseline) - subjective: Pittsburgh Sleep Quality Index (PSQI)
The PSQI is a reliable and validated self-report questionnaire that examines the quality of sleep in the past month. It contains of 19 self-rated questions and 5 questions rated by the bed partner or roommate (if available), covering seven sleep areas: subjective sleep quality, sleep latency, sleep duration, habitual sleep efficiency, sleep disturbances, use of sleeping medication, and daytime dysfunction.
Measured: Baseline
Change in sleep (follow up 1) - subjective: Pittsburgh Sleep Quality Index (PSQI)
The PSQI is a reliable and validated self-report questionnaire that examines the quality of sleep in the past month. It contains of 19 self-rated questions and 5 questions rated by the bed partner or roommate (if available), covering seven sleep areas: subjective sleep quality, sleep latency, sleep duration, habitual sleep efficiency, sleep disturbances, use of sleeping medication, and daytime dysfunction.
Measured: 1 year after baseline
Change in sleep (follow up 2) - subjective: Pittsburgh Sleep Quality Index (PSQI)
The PSQI is a reliable and validated self-report questionnaire that examines the quality of sleep in the past month. It contains of 19 self-rated questions and 5 questions rated by the bed partner or roommate (if available), covering seven sleep areas: subjective sleep quality, sleep latency, sleep duration, habitual sleep efficiency, sleep disturbances, use of sleeping medication, and daytime dysfunction.
Measured: 1 year after follow up 1; 2 years after baseline
Physical activity & Sedentary behaviour (baseline) - objective: accelerometery 1
ActiGraph's wGT3X-BT Activity Monitor (ActiGraph, Pensacola, FL) will be used. It measures time spent in different intensities of physical activity as well as sedentary behaviour and sleep. Participants will be asked to wear the accelerometer continuously during seven consecutive days, day and night, at their non-dominant wrist. In addition to wearing the accelerometer, participants will be asked to fill in a daily succinct diary with: (1) bed times, nap times; (2) non-wear times during the day; and (3) specification of most seated activity. These data will be used to complete and to explain gaps in the data set later on in the software programme. The following PA outcomes will be extracted from the ActiGraph data: average time spent per day in sedentary behaviour, light PA and moderate to vigorous PA.
Measured: baseline
Physical activity & Sedentary behaviour (baseline) - objective: accelerometery 2
A second accelerometer will be placed on the right thigh, namely the activPAL (PAL Technologies Ltd, Glasgow, UK). This device measures postures due to its static acceleration and inclination features. It can quantify postural allocation - which is not possible with the ActiGraph - and is completely waterproof. The following additional PA outcomes will be extracted: time spent sitting/lying, standing, and walking.
Measured: baseline
Change in Physical activity & Sedentary behaviour (follow up 1) - objective: accelerometery 1
ActiGraph's wGT3X-BT Activity Monitor (ActiGraph, Pensacola, FL) will be used. It measures time spent in different intensities of physical activity as well as sedentary behaviour and sleep. Participants will be asked to wear the accelerometer continuously during seven consecutive days, day and night, at their non-dominant wrist. In addition to wearing the accelerometer, participants will be asked to fill in a daily succinct diary with: (1) bed times, nap times; (2) non-wear times during the day; and (3) specification of most seated activity. These data will be used to complete and to explain gaps in the data set later on in the software programme. The following PA outcomes will be extracted from the ActiGraph data: average time spent per day in sedentary behaviour, light PA and moderate to vigorous PA.
Measured: 1 year after baseline
Change in Physical activity & Sedentary behaviour (follow up 1) - objective: accelerometery 2
A second accelerometer will be placed on the right thigh, namely the activPAL (PAL Technologies Ltd, Glasgow, UK). This device measures postures due to its static acceleration and inclination features. It can quantify postural allocation - which is not possible with the ActiGraph - and is completely waterproof. The following additional PA outcomes will be extracted: time spent sitting/lying, standing, and walking.
Measured: 1 year after baseline
Change in Physical activity & Sedentary behaviour (follow up 2) - objective: accelerometery 1
ActiGraph's wGT3X-BT Activity Monitor (ActiGraph, Pensacola, FL) will be used. It measures time spent in different intensities of physical activity as well as sedentary behaviour and sleep. Participants will be asked to wear the accelerometer continuously during seven consecutive days, day and night, at their non-dominant wrist. In addition to wearing the accelerometer, participants will be asked to fill in a daily succinct diary with: (1) bed times, nap times; (2) non-wear times during the day; and (3) specification of most seated activity. These data will be used to complete and to explain gaps in the data set later on in the software programme. The following PA outcomes will be extracted from the ActiGraph data: average time spent per day in sedentary behaviour, light PA and moderate to vigorous PA.
Measured: 1 year after follow up 1; 2 years after baseline
Change in Physical activity & Sedentary behaviour (follow up 2) - objective: accelerometery 2
A second accelerometer will be placed on the right thigh, namely the activPAL (PAL Technologies Ltd, Glasgow, UK). This device measures postures due to its static acceleration and inclination features. It can quantify postural allocation - which is not possible with the ActiGraph - and is completely waterproof. The following additional PA outcomes will be extracted: time spent sitting/lying, standing, and walking.
Measured: 1 year after follow up 1; 2 years after baseline
Physical activity & Sedentary behaviour (baseline) - subjective: International Physical Activity Questionnaire - Short Form (IPAQSF)
The IPAQ-SF is a 7-question measure that assesses frequency and duration of vigorous PA, moderate PA, walking during the past 7 days, as well as time spent sitting.
Measured: baseline
Change in Physical activity & Sedentary behaviour (follow up 1) - subjective: International Physical Activity Questionnaire - Short Form (IPAQSF)
The IPAQ-SF is a 7-question measure that assesses frequency and duration of vigorous PA, moderate PA, walking during the past 7 days, as well as time spent sitting.
Measured: 1 year after baseline
Change in Physical activity & Sedentary behaviour (follow up 2) - subjective: International Physical Activity Questionnaire - Short Form (IPAQSF)
The IPAQ-SF is a 7-question measure that assesses frequency and duration of vigorous PA, moderate PA, walking during the past 7 days, as well as time spent sitting.
Measured: 1 year after follow up 1; 2 years after baseline
Physical activity (baseline) - subjective: muscle strengthening activity questionnaire
Translated version of Muscle-strengthening exercise: Assessing participation and influences - J. Shakespear-Druery, dr. J. Bennie, dr. Katrien De Cocker \& prof. S. Biddle to assess frequency, intensity and duration.
Measured: baseline
Change in Physical activity (follow up 1) - subjective: muscle strengthening activity questionnaire
Translated version of Muscle-strengthening exercise: Assessing participation and influences - J. Shakespear-Druery, dr. J. Bennie, dr. Katrien De Cocker \& prof. S. Biddle to assess frequency, intensity and duration.
Measured: 1 year after baseline
Change in Physical activity (follow up 2) - subjective: muscle strengthening activity questionnaire
Translated version of Muscle-strengthening exercise: Assessing participation and influences - J. Shakespear-Druery, dr. J. Bennie, dr. Katrien De Cocker \& prof. S. Biddle to assess frequency, intensity and duration.
Measured: 1 year after follow up 1; 2 years after baseline
Secondary outcomes (18)
Wellbeing (baseline) - Warwick-Edinburgh Mental Wellbeing Scale (WEMWBS)
The 14-item scale WEMWBS has 5 response categories, summed to provide a single score
Measured: baseline
Wellbeing (follow up 1) - Warwick-Edinburgh Mental Wellbeing Scale (WEMWBS)
The 14-item scale WEMWBS has 5 response categories, summed to provide a single score
Measured: 1 year after baseline
Wellbeing (follow up 2) - Warwick-Edinburgh Mental Wellbeing Scale (WEMWBS)
The 14-item scale WEMWBS has 5 response categories, summed to provide a single score
Measured: 1 year after follow up 1; 2 years after baseline
Global health (baseline) - PROMIS Global health
10-item questionnaire on health
Measured: baseline
Global health (baseline) - PROMIS Global health
10-item questionnaire on health
Measured: 1 year after baseline
Global health (follow up 2) - PROMIS Global health
10-item questionnaire on health
Measured: 1 year after follow up 1; 2 years after baseline
Depression (baseline) - The Geriatric Depression Scale (GDS-15)
15-item questionnaire on depressive symptoms
Measured: baseline
Depression (follow up 1) - The Geriatric Depression Scale (GDS-15)
15-item questionnaire on depressive symptoms
Measured: 1 year after baseline
Depression (follow up 2) - The Geriatric Depression Scale (GDS-15)
15-item questionnaire on depressive symptoms
Measured: 1 year after follow up 1; 2 years after baseline
Loneliness (baseline) - de Jong Gierveld loneliness scale (DJG loneliness)
The 11-item de Jong Gierveld loneliness scale is a multi-dimensional measure of loneliness and contains five positively worded and six negatively worded items. The items fall into four subscales; feelings of severe loneliness, feelings connected with specific problem situations, missing companionship, feelings of belongingness.
Measured: baseline
Loneliness (follow up 1) - de Jong Gierveld loneliness scale (DJG loneliness)
The 11-item de Jong Gierveld loneliness scale is a multi-dimensional measure of loneliness and contains five positively worded and six negatively worded items. The items fall into four subscales; feelings of severe loneliness, feelings connected with specific problem situations, missing companionship, feelings of belongingness.
Measured: 1 year after baseline
Loneliness (follow up 2) - de Jong Gierveld loneliness scale (DJG loneliness)
The 11-item de Jong Gierveld loneliness scale is a multi-dimensional measure of loneliness and contains five positively worded and six negatively worded items. The items fall into four subscales; feelings of severe loneliness, feelings connected with specific problem situations, missing companionship, feelings of belongingness.
Measured: 1 year after follow up 1; 2 years after baseline
Social network (baseline) - Lubben Social Network Scale (LSN-6)
LSNS-6 provides quantitative information on their family and friendship ties, and identifies persons at increased risk for social isolation
Measured: baseline
Social network (follow up 1) - Lubben Social Network Scale (LSN-6)
LSNS-6 provides quantitative information on their family and friendship ties, and identifies persons at increased risk for social isolation
Measured: 1 year after baseline
Social network (follow up 2) - Lubben Social Network Scale (LSN-6)
LSNS-6 provides quantitative information on their family and friendship ties, and identifies persons at increased risk for social isolation
Measured: 1 year after follow up 1; 2 years after baseline
Expectations Regarding Aging (baseline) - 12-Item Expectations Regarding Aging survey
12-Item Expectations Regarding Aging
Measured: baseline
Expectations Regarding Aging (follow-up 1) - 12-Item Expectations Regarding Aging survey
12-Item Expectations Regarding Aging
Measured: 1 year after baseline
Expectations Regarding Aging (follow-up 2) - 12-Item Expectations Regarding Aging survey
12-Item Expectations Regarding Aging
Measured: 1 year after follow up 1; 2 years after baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jul 2022
- Study start22 Jul 2021
- Primary completion31 Mar 2024
- Study completion31 Mar 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cognitive AgingStudies of the same condition, open and under way.
- More trials run by KU LeuvenThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 260 participants (actual)
Sponsor and investigators
- Lead sponsor
- KU Leuven
- Sponsor type
- University, hospital or other
- Collaborators
- University Ghent, Research Foundation Flanders
- Responsible party
- Principal investigator, Pieter-Jan Marent, KU Leuven
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05455229
- Sponsor's protocol ID
- PASOCA_2021
- Acronym
- PASOCA
- Status last verified
- Feb 2025
- First submitted
- 8 Nov 2021
- Last updated
- 13 Feb 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: All anonymised textual and numerical data will be available after the end of the project in an Open Access repository or upon request by mail.
Study at a glance
From the registry record, last updated by the sponsor on 13 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Elucidating How Physical Activity and Sleep Relate to Optimal Cognitive Ageing: the PASOCA- Study
- ClinicalTrials.gov ID
- NCT05455229
- Acronym / sponsor ID
- PASOCA / PASOCA_2021
- Conditions
- Cognitive Aging
- Keywords
- Physical activity, Sedentary behaviour, Sleep, Cognition, Ageing, Longitudinal, Observational, Accelerometry
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 260 participants (actual)
- Lead sponsor
- KU LeuvenUniversity, hospital or other
- Collaborators
- University Ghent, Research Foundation Flanders
- Study start
- 22 Jul 2021 (actual)
- Primary completion
- 31 Mar 2024 (actual)
- Study completion
- 31 Mar 2024 (actual)
- First posted
- 13 Jul 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Increased longevity is one of the greatest success stories in public health. However, ageing is accompanied by cognitive decline which affects people's daily functioning and, if it develops to dementia, their ability to live independently. By 2050, the number of people who develop dementia will triple to 152 million. The aim of this project is to precisely examine how physical activity (PA) and sleep, both modifiable lifestyle factors, are related to cognitive function and which role they can play in optimal cognitive ageing. To do so, a longitudinal study will be conducted, with objective measures of PA, sleep and cognition in midlife and older adults. This project will meet the current need for longitudinal studies with objective PA and sleep data, as well as provide, for the first time, in-depth information on associations of type of PA (aerobic vs muscle strengthening), characteristics of sleep (quality vs quantity) with specific cognitive domains (executive function and memory). Furthermore, although PA and sleep are related, the behavioural dynamics of combinations of PA and sleep on cognition has never been studied before. To fill this gap, these relationships will be examined with an innovative statistical approach, looking at data across a 24-hour period. The resulting deeper understanding of the precise relationship between PA, sleep and cognitive function will contribute to the development of preventive interventions for maintaining cognitive health at older age.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 55 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Community dwelling, healthy adults aged 55 and above living in Belgium.
Key inclusion criteria (1 listed)
- Community dwelling, healthy adults aged 55 and above
Key exclusion criteria (11 listed)
- has a neurodegenerative disease such as Parkinson's, Alzheimer's, MS…; or
- has a psychiatric illness such as bipolar disorder, OCD…; or
- has had a serious brain injury in the past year or before that is still affecting them; or
- has had a brain haemorrhage; or
- is currently experiencing a depressive episode; or
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Cognitive function (baseline) - objective: executive function and memory will be tested with Cambridge Neuropsychological Test Automated Battery (CANTAB)
Time frame: baseline
Executive functions and memory will be the main outcome measure for cognitive function. Executive control (planning, shifting, inhibiting, attention) and memory (visuospatial, episodic, verbal) functions will be measured objectively using an iPad with the validated CANTAB software (cambridgecognition.com). Specific tasks in the test battery: * Practice: MOT (Motor Screening Task) * Memory: PAL (Paired Associates Learning), DMS (Delayed Matching to Sample), VRM (Verbal Recognition Memory) * Executive control: MTT Multitasking Test, OTS (One Touch Stockings of Cambridge), SWM (Spatial Working Memory)
Change in cognitive function (follow up 1) - objective: executive function and memory will be tested with Cambridge Neuropsychological Test Automated Battery (CANTAB)
Time frame: 1 year after baseline
Executive functions and memory will be the main outcome measure for cognitive function. Executive control (planning, shifting, inhibiting, attention) and memory (visuospatial, episodic, verbal) functions will be measured objectively using an iPad with the validated CANTAB software (cambridgecognition.com). Specific tasks in the test battery: * Practice: MOT (Motor Screening Task) * Memory: PAL (Paired Associates Learning), DMS (Delayed Matching to Sample), VRM (Verbal Recognition Memory) * Executive control: MTT Multitasking Test, OTS (One Touch Stockings of Cambridge), SWM (Spatial Working Memory)
Change in cognitive function (follow up 2) - objective: executive function and memory will be tested with Cambridge Neuropsychological Test Automated Battery (CANTAB)
Time frame: 1 year after follow up 1; 2 years after baseline
Executive functions and memory will be the main outcome measure for cognitive function. Executive control (planning, shifting, inhibiting, attention) and memory (visuospatial, episodic, verbal) functions will be measured objectively using an iPad with the validated CANTAB software (cambridgecognition.com). Specific tasks in the test battery: * Practice: MOT (Motor Screening Task) * Memory: PAL (Paired Associates Learning), DMS (Delayed Matching to Sample), VRM (Verbal Recognition Memory) * Executive control: MTT Multitasking Test, OTS (One Touch Stockings of Cambridge), SWM (Spatial Working Memory)
Cognitive function (baseline) - subjective: Cognitive Failure Questionnaire
Time frame: baseline
25-items will be used to measure subjective cognitive decline by assessing self-reported frequency of failures in several cognitive domains.
Change in cognitive function (follow up 1) - subjective: Cognitive Failure Questionnaire
Time frame: 1 year after baseline
25-items will be used to measure subjective cognitive decline by assessing self-reported frequency of failures in several cognitive domains.
Change in cognitive function (follow up 2) - subjective: Cognitive Failure Questionnaire
Time frame: 1 year after follow up 1; 2 years after baseline
25-items will be used to measure subjective cognitive decline by assessing self-reported frequency of failures in several cognitive domains.
Sleep (baseline) - objective: accelerometery - characteristic 1: total sleep time
Time frame: baseline
Specifically ActiGraph's wGT3X-BT Activity Monitor (ActiGraph, Pensacola, FL). Placement at the wrist results in the increased wear time and accuracy of sleep measurement. Total sleep time is measured in minutes.
Sleep (baseline) - objective: accelerometery - characteristic 2: wake after sleep onset
Time frame: baseline
Specifically ActiGraph's wGT3X-BT Activity Monitor (ActiGraph, Pensacola, FL). Placement at the wrist results in the increased wear time and accuracy of sleep measurement. Wake after sleep onset is measured in minutes.
Sleep (baseline) - objective: accelerometery - characteristic 3: sleep efficiency
Time frame: baseline
Specifically ActiGraph's wGT3X-BT Activity Monitor (ActiGraph, Pensacola, FL). Placement at the wrist results in the increased wear time and accuracy of sleep measurement. Sleep efficiency is displayed in percentage.
Sleep (baseline) - objective: accelerometery - characteristic 4: sleep latency
Time frame: baseline
Specifically ActiGraph's wGT3X-BT Activity Monitor (ActiGraph, Pensacola, FL). Placement at the wrist results in the increased wear time and accuracy of sleep measurement. Sleep latency is measured in minutes.
Change in sleep (follow up 1) - objective: accelerometery - characteristic 1: total sleep time
Time frame: 1 year after baseline
Specifically ActiGraph's wGT3X-BT Activity Monitor (ActiGraph, Pensacola, FL). Placement at the wrist results in the increased wear time and accuracy of sleep measurement. Total sleep time is measured in minutes.
Change in sleep (follow up 1) - objective: accelerometery - characteristic 2: wake after sleep onset
Time frame: 1 year after baseline
Specifically ActiGraph's wGT3X-BT Activity Monitor (ActiGraph, Pensacola, FL). Placement at the wrist results in the increased wear time and accuracy of sleep measurement. Wake after sleep onset is measured in minutes.
Change in sleep (follow up 1) - objective: accelerometery - characteristic 3: sleep efficiency
Time frame: 1 year after baseline
Specifically ActiGraph's wGT3X-BT Activity Monitor (ActiGraph, Pensacola, FL). Placement at the wrist results in the increased wear time and accuracy of sleep measurement. Sleep efficiency is displayed in percentage.
Change in sleep (follow up 1) - objective: accelerometery - characteristic 4: sleep latency
Time frame: 1 year after baseline
Specifically ActiGraph's wGT3X-BT Activity Monitor (ActiGraph, Pensacola, FL). Placement at the wrist results in the increased wear time and accuracy of sleep measurement. Sleep latency is measured in minutes.
Change in sleep (follow up 2) - objective: accelerometery - characteristic 1: total sleep time
Time frame: 1 year after follow up 1; 2 years after baseline
Specifically ActiGraph's wGT3X-BT Activity Monitor (ActiGraph, Pensacola, FL). Placement at the wrist results in the increased wear time and accuracy of sleep measurement. Total sleep time is measured in minutes.
Change in sleep (follow up 2) - objective: accelerometery - characteristic 2: wake after
Time frame: 1 year after follow up 1; 2 years after baseline
Specifically ActiGraph's wGT3X-BT Activity Monitor (ActiGraph, Pensacola, FL). Placement at the wrist results in the increased wear time and accuracy of sleep measurement. Wake after sleep onset is measured in minutes.
Change in sleep (follow up 2) - objective: accelerometery - characteristic 3: sleep efficiency
Time frame: 1 year after follow up 1; 2 years after baseline
Specifically ActiGraph's wGT3X-BT Activity Monitor (ActiGraph, Pensacola, FL). Placement at the wrist results in the increased wear time and accuracy of sleep measurement. Sleep efficiency is displayed in percentage.
Change in sleep (follow up 2) - objective: accelerometery - characteristic 4: sleep latency
Time frame: 1 year after follow up 1; 2 years after baseline
Specifically ActiGraph's wGT3X-BT Activity Monitor (ActiGraph, Pensacola, FL). Placement at the wrist results in the increased wear time and accuracy of sleep measurement. Sleep latency is measured in minutes.
Sleep (baseline) - subjective: Pittsburgh Sleep Quality Index (PSQI)
Time frame: Baseline
The PSQI is a reliable and validated self-report questionnaire that examines the quality of sleep in the past month. It contains of 19 self-rated questions and 5 questions rated by the bed partner or roommate (if available), covering seven sleep areas: subjective sleep quality, sleep latency, sleep duration, habitual sleep efficiency, sleep disturbances, use of sleeping medication, and daytime dysfunction.
Change in sleep (follow up 1) - subjective: Pittsburgh Sleep Quality Index (PSQI)
Time frame: 1 year after baseline
The PSQI is a reliable and validated self-report questionnaire that examines the quality of sleep in the past month. It contains of 19 self-rated questions and 5 questions rated by the bed partner or roommate (if available), covering seven sleep areas: subjective sleep quality, sleep latency, sleep duration, habitual sleep efficiency, sleep disturbances, use of sleeping medication, and daytime dysfunction.
Change in sleep (follow up 2) - subjective: Pittsburgh Sleep Quality Index (PSQI)
Time frame: 1 year after follow up 1; 2 years after baseline
The PSQI is a reliable and validated self-report questionnaire that examines the quality of sleep in the past month. It contains of 19 self-rated questions and 5 questions rated by the bed partner or roommate (if available), covering seven sleep areas: subjective sleep quality, sleep latency, sleep duration, habitual sleep efficiency, sleep disturbances, use of sleeping medication, and daytime dysfunction.
Physical activity & Sedentary behaviour (baseline) - objective: accelerometery 1
Time frame: baseline
ActiGraph's wGT3X-BT Activity Monitor (ActiGraph, Pensacola, FL) will be used. It measures time spent in different intensities of physical activity as well as sedentary behaviour and sleep. Participants will be asked to wear the accelerometer continuously during seven consecutive days, day and night, at their non-dominant wrist. In addition to wearing the accelerometer, participants will be asked to fill in a daily succinct diary with: (1) bed times, nap times; (2) non-wear times during the day; and (3) specification of most seated activity. These data will be used to complete and to explain gaps in the data set later on in the software programme. The following PA outcomes will be extracted from the ActiGraph data: average time spent per day in sedentary behaviour, light PA and moderate to vigorous PA.
Physical activity & Sedentary behaviour (baseline) - objective: accelerometery 2
Time frame: baseline
A second accelerometer will be placed on the right thigh, namely the activPAL (PAL Technologies Ltd, Glasgow, UK). This device measures postures due to its static acceleration and inclination features. It can quantify postural allocation - which is not possible with the ActiGraph - and is completely waterproof. The following additional PA outcomes will be extracted: time spent sitting/lying, standing, and walking.
Change in Physical activity & Sedentary behaviour (follow up 1) - objective: accelerometery 1
Time frame: 1 year after baseline
ActiGraph's wGT3X-BT Activity Monitor (ActiGraph, Pensacola, FL) will be used. It measures time spent in different intensities of physical activity as well as sedentary behaviour and sleep. Participants will be asked to wear the accelerometer continuously during seven consecutive days, day and night, at their non-dominant wrist. In addition to wearing the accelerometer, participants will be asked to fill in a daily succinct diary with: (1) bed times, nap times; (2) non-wear times during the day; and (3) specification of most seated activity. These data will be used to complete and to explain gaps in the data set later on in the software programme. The following PA outcomes will be extracted from the ActiGraph data: average time spent per day in sedentary behaviour, light PA and moderate to vigorous PA.
Change in Physical activity & Sedentary behaviour (follow up 1) - objective: accelerometery 2
Time frame: 1 year after baseline
A second accelerometer will be placed on the right thigh, namely the activPAL (PAL Technologies Ltd, Glasgow, UK). This device measures postures due to its static acceleration and inclination features. It can quantify postural allocation - which is not possible with the ActiGraph - and is completely waterproof. The following additional PA outcomes will be extracted: time spent sitting/lying, standing, and walking.
Change in Physical activity & Sedentary behaviour (follow up 2) - objective: accelerometery 1
Time frame: 1 year after follow up 1; 2 years after baseline
ActiGraph's wGT3X-BT Activity Monitor (ActiGraph, Pensacola, FL) will be used. It measures time spent in different intensities of physical activity as well as sedentary behaviour and sleep. Participants will be asked to wear the accelerometer continuously during seven consecutive days, day and night, at their non-dominant wrist. In addition to wearing the accelerometer, participants will be asked to fill in a daily succinct diary with: (1) bed times, nap times; (2) non-wear times during the day; and (3) specification of most seated activity. These data will be used to complete and to explain gaps in the data set later on in the software programme. The following PA outcomes will be extracted from the ActiGraph data: average time spent per day in sedentary behaviour, light PA and moderate to vigorous PA.
Change in Physical activity & Sedentary behaviour (follow up 2) - objective: accelerometery 2
Time frame: 1 year after follow up 1; 2 years after baseline
A second accelerometer will be placed on the right thigh, namely the activPAL (PAL Technologies Ltd, Glasgow, UK). This device measures postures due to its static acceleration and inclination features. It can quantify postural allocation - which is not possible with the ActiGraph - and is completely waterproof. The following additional PA outcomes will be extracted: time spent sitting/lying, standing, and walking.
Physical activity & Sedentary behaviour (baseline) - subjective: International Physical Activity Questionnaire - Short Form (IPAQSF)
Time frame: baseline
The IPAQ-SF is a 7-question measure that assesses frequency and duration of vigorous PA, moderate PA, walking during the past 7 days, as well as time spent sitting.
Change in Physical activity & Sedentary behaviour (follow up 1) - subjective: International Physical Activity Questionnaire - Short Form (IPAQSF)
Time frame: 1 year after baseline
The IPAQ-SF is a 7-question measure that assesses frequency and duration of vigorous PA, moderate PA, walking during the past 7 days, as well as time spent sitting.
Change in Physical activity & Sedentary behaviour (follow up 2) - subjective: International Physical Activity Questionnaire - Short Form (IPAQSF)
Time frame: 1 year after follow up 1; 2 years after baseline
The IPAQ-SF is a 7-question measure that assesses frequency and duration of vigorous PA, moderate PA, walking during the past 7 days, as well as time spent sitting.
Physical activity (baseline) - subjective: muscle strengthening activity questionnaire
Time frame: baseline
Translated version of Muscle-strengthening exercise: Assessing participation and influences - J. Shakespear-Druery, dr. J. Bennie, dr. Katrien De Cocker \& prof. S. Biddle to assess frequency, intensity and duration.
Change in Physical activity (follow up 1) - subjective: muscle strengthening activity questionnaire
Time frame: 1 year after baseline
Translated version of Muscle-strengthening exercise: Assessing participation and influences - J. Shakespear-Druery, dr. J. Bennie, dr. Katrien De Cocker \& prof. S. Biddle to assess frequency, intensity and duration.
Change in Physical activity (follow up 2) - subjective: muscle strengthening activity questionnaire
Time frame: 1 year after follow up 1; 2 years after baseline
Translated version of Muscle-strengthening exercise: Assessing participation and influences - J. Shakespear-Druery, dr. J. Bennie, dr. Katrien De Cocker \& prof. S. Biddle to assess frequency, intensity and duration.
18 secondary outcomes
Wellbeing (baseline) - Warwick-Edinburgh Mental Wellbeing Scale (WEMWBS)
Time frame: baseline
Wellbeing (follow up 1) - Warwick-Edinburgh Mental Wellbeing Scale (WEMWBS)
Time frame: 1 year after baseline
Wellbeing (follow up 2) - Warwick-Edinburgh Mental Wellbeing Scale (WEMWBS)
Time frame: 1 year after follow up 1; 2 years after baseline
Global health (baseline) - PROMIS Global health
Time frame: baseline
Global health (baseline) - PROMIS Global health
Time frame: 1 year after baseline
Global health (follow up 2) - PROMIS Global health
Time frame: 1 year after follow up 1; 2 years after baseline
Depression (baseline) - The Geriatric Depression Scale (GDS-15)
Time frame: baseline
Depression (follow up 1) - The Geriatric Depression Scale (GDS-15)
Time frame: 1 year after baseline
Depression (follow up 2) - The Geriatric Depression Scale (GDS-15)
Time frame: 1 year after follow up 1; 2 years after baseline
Loneliness (baseline) - de Jong Gierveld loneliness scale (DJG loneliness)
Time frame: baseline
Loneliness (follow up 1) - de Jong Gierveld loneliness scale (DJG loneliness)
Time frame: 1 year after baseline
Loneliness (follow up 2) - de Jong Gierveld loneliness scale (DJG loneliness)
Time frame: 1 year after follow up 1; 2 years after baseline
Social network (baseline) - Lubben Social Network Scale (LSN-6)
Time frame: baseline
Social network (follow up 1) - Lubben Social Network Scale (LSN-6)
Time frame: 1 year after baseline
Social network (follow up 2) - Lubben Social Network Scale (LSN-6)
Time frame: 1 year after follow up 1; 2 years after baseline
Expectations Regarding Aging (baseline) - 12-Item Expectations Regarding Aging survey
Time frame: baseline
Expectations Regarding Aging (follow-up 1) - 12-Item Expectations Regarding Aging survey
Time frame: 1 year after baseline
Expectations Regarding Aging (follow-up 2) - 12-Item Expectations Regarding Aging survey
Time frame: 1 year after follow up 1; 2 years after baseline
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Feb 2025.
- Individual participant dataSharing planned: Yes. All anonymised textual and numerical data will be available after the end of the project in an Open Access repository or upon request by mail.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Cognitive Aging, run by KU Leuven at 1 site in Belgium.
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 1 inclusion and 11 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 13 Feb 2025. 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 Belgium. 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. 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?
Cognitive function (baseline) - objective: executive function and memory will be tested with Cambridge Neuropsychological Test Automated Battery (CANTAB) (time frame: baseline). The study lists 33 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 13 Feb 2025.