Elucidating How Physical Activity and Sleep Relate to Optimal Cognitive Ageing

Cognitive Aging Clinical Trial

— PASOCA  

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT05455229
• Other study ID #: PASOCA_2021
• Status: Active, not recruiting
• Start date: July 22, 2021
• Est. completion date: December 31, 2024

Study information

• Verified date: October 2023
• Source: KU Leuven
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical 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. 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 260
• Est. completion date: December 31, 2024
• Est. primary completion date: March 31, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 55 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Cognitive Aging

Locations

Country	Name	City	State
Belgium	KU Leuven	Leuven	Vlaams-Brabant

Sponsors (3)

Lead Sponsor	Collaborator
KU Leuven	Research Foundation Flanders, University Ghent

Country where clinical trial is conducted

Belgium, 

Outcome

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