Elucidating How Physical Activity and Sleep Relate to Optimal Cognitive Ageing (PASOCA)

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Cognitive Aging

• Study Type: Observational
• Enrollment (Actual): 260

Contacts and Locations

Study Locations

• Belgium
  • Vlaams-Brabant
    • Leuven, Vlaams-Brabant, Belgium, 3000
      • KU Leuven

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 55 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

• Sampling Method: Probability Sample

Study Population

Community dwelling, healthy adults aged 55 and above living in Belgium.

Description

Inclusion Criteria:

• Community dwelling, healthy adults aged 55 and above

Exclusion Criteria:

1. has a neurodegenerative disease such as Parkinson's, Alzheimer's, MS…; or
2. has a psychiatric illness such as bipolar disorder, OCD…; or
3. has had a serious brain injury in the past year or before that is still affecting them; or
4. has had a brain haemorrhage; or
5. is currently experiencing a depressive episode; or
6. has a history of addiction or excessive alcohol abuse; or
7. uses a sleeping device (for sleep apnoea); or
8. has chronic insomnia (diagnosed insomnia); or
9. is severely limited in performing daily activities (up and down stairs, walk ...)
10. has a first-degree dementia within the family
11. scores a 23 or lower on the Montreal Cognitive Assessment

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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)	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)	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)	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.	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.	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.	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.	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.	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.	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.	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.	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.	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.	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.	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.	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.	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.	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.	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.	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.	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.	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.	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.	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.	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.	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.	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.	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.	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.	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.	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.	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.	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.	1 year after follow up 1; 2 years after baseline

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Wellbeing (baseline) - Warwick-Edinburgh Mental Wellbeing Scale (WEMWBS)	The 14-item scale WEMWBS has 5 response categories, summed to provide a single score	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	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	1 year after follow up 1; 2 years after baseline
Global health (baseline) - PROMIS Global health	10-item questionnaire on health	baseline
Global health (baseline) - PROMIS Global health	10-item questionnaire on health	1 year after baseline
Global health (follow up 2) - PROMIS Global health	10-item questionnaire on health	1 year after follow up 1; 2 years after baseline
Depression (baseline) - The Geriatric Depression Scale (GDS-15)	15-item questionnaire on depressive symptoms	baseline
Depression (follow up 1) - The Geriatric Depression Scale (GDS-15)	15-item questionnaire on depressive symptoms	1 year after baseline
Depression (follow up 2) - The Geriatric Depression Scale (GDS-15)	15-item questionnaire on depressive symptoms	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.	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.	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.	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	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	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	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	baseline
Expectations Regarding Aging (follow-up 1) - 12-Item Expectations Regarding Aging survey	12-Item Expectations Regarding Aging	1 year after baseline
Expectations Regarding Aging (follow-up 2) - 12-Item Expectations Regarding Aging survey	12-Item Expectations Regarding Aging	1 year after follow up 1; 2 years after baseline

Collaborators and Investigators

• Sponsor: KU Leuven
• Collaborators: University Ghent; Research Foundation Flanders

Study record dates

Study Major Dates

• Study Start (Actual): July 22, 2021
• Primary Completion (Estimated): March 31, 2024
• Study Completion (Estimated): December 31, 2024

Study Registration Dates

• First Submitted: November 8, 2021
• First Submitted That Met QC Criteria: July 7, 2022
• First Posted (Actual): July 13, 2022

Study Record Updates

• Last Update Posted (Actual): October 5, 2023
• Last Update Submitted That Met QC Criteria: October 4, 2023
• Last Verified: October 1, 2023

More Information

Terms related to this study

• Keywords: Ageing; Sleep; Physical activity; Observational; Cognition; Accelerometry; Longitudinal; Sedentary behaviour
• Other Study ID Numbers: PASOCA_2021

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: 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.
• IPD Sharing Time Frame: Upon publication of the research results

IPD Sharing Access Criteria

Researchers with a track record in the field of healthy ageing or physical activity and health and proven experience in the analysis of variables as collected in the study will be able to access the data.

Data from the project that can be shared will be made available under a Creative Commons attribution license (CC-BY-NC-SA 4.0) so that users have to give credit to the original data creators.

• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; ICF; ANALYTIC_CODE

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No