Skip to main content
OpenTrials
Completed

NCT Number: NCT05455229

Elucidating How Physical Activity and Sleep Relate to Optimal Cognitive Ageing

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Cognitive Aging Behavior Motor Activity

Age range

55 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

KU Leuven

Leuven, Vlaams-Brabant, 3000, Belgium

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Community dwelling, healthy adults aged 55 and above

Exclusion criteria

  • 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

Treatment and study plan

Primary outcomes

  1. 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)

  2. 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)

  3. 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)

  4. 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.

  5. 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.

  6. 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.

  7. 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.

  8. 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.

  9. 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.

  10. 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.

  11. 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.

  12. 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.

  13. 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.

  14. 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.

  15. 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.

  16. 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.

  17. 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.

  18. 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.

  19. 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.

  20. 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.

  21. 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.

  22. 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.

  23. 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.

  24. 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.

  25. 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.

  26. 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.

  27. 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.

  28. 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.

  29. 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.

  30. 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.

  31. 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.

  32. 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.

  33. 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.

Secondary outcomes

  1. Wellbeing (baseline) - Warwick-Edinburgh Mental Wellbeing Scale (WEMWBS)

    Time frame: baseline

    The 14-item scale WEMWBS has 5 response categories, summed to provide a single score

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

    Time frame: 1 year after baseline

    The 14-item scale WEMWBS has 5 response categories, summed to provide a single score

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

    Time frame: 1 year after follow up 1; 2 years after baseline

    The 14-item scale WEMWBS has 5 response categories, summed to provide a single score

  4. Global health (baseline) - PROMIS Global health

    Time frame: baseline

    10-item questionnaire on health

  5. Global health (baseline) - PROMIS Global health

    Time frame: 1 year after baseline

    10-item questionnaire on health

  6. Global health (follow up 2) - PROMIS Global health

    Time frame: 1 year after follow up 1; 2 years after baseline

    10-item questionnaire on health

  7. Depression (baseline) - The Geriatric Depression Scale (GDS-15)

    Time frame: baseline

    15-item questionnaire on depressive symptoms

  8. Depression (follow up 1) - The Geriatric Depression Scale (GDS-15)

    Time frame: 1 year after baseline

    15-item questionnaire on depressive symptoms

  9. Depression (follow up 2) - The Geriatric Depression Scale (GDS-15)

    Time frame: 1 year after follow up 1; 2 years after baseline

    15-item questionnaire on depressive symptoms

  10. Loneliness (baseline) - de Jong Gierveld loneliness scale (DJG loneliness)

    Time frame: baseline

    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.

  11. Loneliness (follow up 1) - de Jong Gierveld loneliness scale (DJG loneliness)

    Time frame: 1 year after baseline

    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.

  12. Loneliness (follow up 2) - de Jong Gierveld loneliness scale (DJG loneliness)

    Time frame: 1 year after follow up 1; 2 years after baseline

    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.

  13. Social network (baseline) - Lubben Social Network Scale (LSN-6)

    Time frame: baseline

    LSNS-6 provides quantitative information on their family and friendship ties, and identifies persons at increased risk for social isolation

  14. Social network (follow up 1) - Lubben Social Network Scale (LSN-6)

    Time frame: 1 year after baseline

    LSNS-6 provides quantitative information on their family and friendship ties, and identifies persons at increased risk for social isolation

  15. Social network (follow up 2) - Lubben Social Network Scale (LSN-6)

    Time frame: 1 year after follow up 1; 2 years after baseline

    LSNS-6 provides quantitative information on their family and friendship ties, and identifies persons at increased risk for social isolation

  16. Expectations Regarding Aging (baseline) - 12-Item Expectations Regarding Aging survey

    Time frame: baseline

    12-Item Expectations Regarding Aging

  17. Expectations Regarding Aging (follow-up 1) - 12-Item Expectations Regarding Aging survey

    Time frame: 1 year after baseline

    12-Item Expectations Regarding Aging

  18. Expectations Regarding Aging (follow-up 2) - 12-Item Expectations Regarding Aging survey

    Time frame: 1 year after follow up 1; 2 years after baseline

    12-Item Expectations Regarding Aging

Sponsors and collaborators

Lead sponsor

KU Leuven

Other

Collaborators

  • Research Foundation Flanders
  • University Ghent

Registry information

Official study title

Elucidating How Physical Activity and Sleep Relate to Optimal Cognitive Ageing: the PASOCA- Study

Acronym: PASOCA

Important dates

Study start
2021
Primary completion
2024
Study completion
2024
First posted
Jul 13, 2022
Registry last updated
Feb 13, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.