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Elucidating How Physical Activity and Sleep Relate to Optimal Cognitive Ageing

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

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT05455229
Acronym
PASOCA
Enrollment
260
Registered
2022-07-13
Start date
2021-07-22
Completion date
2024-03-31
Last updated
2025-02-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cognitive Aging

Keywords

Physical activity, Sedentary behaviour, Sleep, Cognition, Ageing, Longitudinal, Observational, Accelerometry

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.

Interventions

None listed

Sponsors

University Ghent
CollaboratorOTHER
Research Foundation Flanders
CollaboratorOTHER
KU Leuven
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
55 Years to No maximum
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
Change in Physical activity (follow up 2) - subjective: muscle strengthening activity questionnaire1 year after follow up 1; 2 years after baselineTranslated 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 sleep (follow up 2) - objective: accelerometery - characteristic 1: total sleep time1 year after follow up 1; 2 years after baselineSpecifically 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 3: sleep efficiency1 year after follow up 1; 2 years after baselineSpecifically 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 latency1 year after follow up 1; 2 years after baselineSpecifically 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)BaselineThe 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)1 year after baselineThe 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)1 year after follow up 1; 2 years after baselineThe 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 1baselineActiGraph'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 2baselineA 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 11 year after baselineActiGraph'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 21 year after baselineA 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 11 year after follow up 1; 2 years after baselineActiGraph'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 21 year after follow up 1; 2 years after baselineA 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)baselineThe 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)1 year after baselineThe 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)1 year after follow up 1; 2 years after baselineThe 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 questionnairebaselineTranslated 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 questionnaire1 year after baselineTranslated 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 sleep (follow up 2) - objective: accelerometery - characteristic 2: wake after1 year after follow up 1; 2 years after baselineSpecifically 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.
Cognitive function (baseline) - objective: executive function and memory will be tested with Cambridge Neuropsychological Test Automated Battery (CANTAB)baselineExecutive 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)1 year after baselineExecutive 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)1 year after follow up 1; 2 years after baselineExecutive 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 Questionnairebaseline25-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 Questionnaire1 year after baseline25-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 Questionnaire1 year after follow up 1; 2 years after baseline25-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 timebaselineSpecifically 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 onsetbaselineSpecifically 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 efficiencybaselineSpecifically 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 latencybaselineSpecifically 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 time1 year after baselineSpecifically 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 onset1 year after baselineSpecifically 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 efficiency1 year after baselineSpecifically 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 latency1 year after baselineSpecifically 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.

Secondary

MeasureTime frameDescription
Wellbeing (follow up 1) - Warwick-Edinburgh Mental Wellbeing Scale (WEMWBS)1 year after baselineThe 14-item scale WEMWBS has 5 response categories, summed to provide a single score
Wellbeing (follow up 2) - Warwick-Edinburgh Mental Wellbeing Scale (WEMWBS)1 year after follow up 1; 2 years after baselineThe 14-item scale WEMWBS has 5 response categories, summed to provide a single score
Global health (baseline) - PROMIS Global healthbaseline10-item questionnaire on health
Global health (follow up 2) - PROMIS Global health1 year after follow up 1; 2 years after baseline10-item questionnaire on health
Depression (baseline) - The Geriatric Depression Scale (GDS-15)baseline15-item questionnaire on depressive symptoms
Depression (follow up 1) - The Geriatric Depression Scale (GDS-15)1 year after baseline15-item questionnaire on depressive symptoms
Depression (follow up 2) - The Geriatric Depression Scale (GDS-15)1 year after follow up 1; 2 years after baseline15-item questionnaire on depressive symptoms
Loneliness (baseline) - de Jong Gierveld loneliness scale (DJG loneliness)baselineThe 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.
Loneliness (follow up 1) - de Jong Gierveld loneliness scale (DJG loneliness)1 year after baselineThe 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.
Loneliness (follow up 2) - de Jong Gierveld loneliness scale (DJG loneliness)1 year after follow up 1; 2 years after baselineThe 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.
Social network (baseline) - Lubben Social Network Scale (LSN-6)baselineLSNS-6 provides quantitative information on their family and friendship ties, and identifies persons at increased risk for social isolation
Social network (follow up 1) - Lubben Social Network Scale (LSN-6)1 year after baselineLSNS-6 provides quantitative information on their family and friendship ties, and identifies persons at increased risk for social isolation
Social network (follow up 2) - Lubben Social Network Scale (LSN-6)1 year after follow up 1; 2 years after baselineLSNS-6 provides quantitative information on their family and friendship ties, and identifies persons at increased risk for social isolation
Expectations Regarding Aging (baseline) - 12-Item Expectations Regarding Aging surveybaseline12-Item Expectations Regarding Aging
Expectations Regarding Aging (follow-up 1) - 12-Item Expectations Regarding Aging survey1 year after baseline12-Item Expectations Regarding Aging
Expectations Regarding Aging (follow-up 2) - 12-Item Expectations Regarding Aging survey1 year after follow up 1; 2 years after baseline12-Item Expectations Regarding Aging
Wellbeing (baseline) - Warwick-Edinburgh Mental Wellbeing Scale (WEMWBS)baselineThe 14-item scale WEMWBS has 5 response categories, summed to provide a single score

Countries

Belgium

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026