Elucidating How Physical Activity and Sleep Relate to Optimal Cognitive Ageing

NCT05455229 | Completed DMC

• 1 other identifier: PASOCA_2021
• Study Type: observational
• Target: 260
• Locations: 1 country
• Sites: 1

Brief 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. 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

Outcome Measures

Primary Outcomes (33)

• 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 Outcomes (18)

• Wellbeing (baseline) - Warwick-Edinburgh Mental Wellbeing Scale (WEMWBS)

  baseline

• Wellbeing (follow up 1) - Warwick-Edinburgh Mental Wellbeing Scale (WEMWBS)

  1 year after baseline

• Wellbeing (follow up 2) - Warwick-Edinburgh Mental Wellbeing Scale (WEMWBS)

  1 year after follow up 1; 2 years after baseline

• Global health (baseline) - PROMIS Global health

  baseline

• Global health (baseline) - PROMIS Global health

  1 year after baseline

Eligibility Criteria

• Age: 55 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

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

You may qualify if:

• Community dwelling, healthy adults aged 55 and above

You may not qualify if:

• 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
• 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

Sponsors & Collaborators

• KU Leuven: lead
• University Ghent: collaborator
• Research Foundation Flanders: collaborator

Study Sites (1)

KU Leuven

Leuven, Vlaams-Brabant, 3000, Belgium

Location

MeSH Terms

Conditions

Motor Activity

Condition Hierarchy (Ancestors)

Behavior

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: November 8, 2021
• First Posted: July 13, 2022
• Study Start: July 22, 2021
• Primary Completion: March 31, 2024
• Study Completion: March 31, 2024
• Last Updated: February 13, 2025

Record last verified: 2025-02

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, ANALYTIC CODE
• Time Frame: Upon publication of the research results
• 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.

Locations

BE (1)