Clinical trial NCT05455229: Elucidating How Physical Activity and Sleep Relate to Optimal Cognitive Ageing
Official title: Elucidating How Physical Activity and Sleep Relate to Optimal Cognitive Ageing: the PASOCA- Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Cognitive Aging
Keywords: Physical activity
Sedentary behaviour
Sleep
Cognition
Ageing
Longitudinal
Observational
Accelerometry
Lead sponsor: KU Leuven
Sponsor class: OTHER
Collaborators: name: University Ghent
name: Research Foundation Flanders
First posted: 2022-07-13
Enrollment: 260
Sex: ALL
Minimum age (years): 55
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Community dwelling, healthy adults aged 55 and above living in Belgium.

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.


Eligibility criteria: 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

Primary outcomes:
measure: Cognitive function (baseline) - objective: executive function and memory will be tested with Cambridge Neuropsychological Test Automated Battery (CANTAB)
timeFrame: baseline
measure: Change in cognitive function (follow up 1) - objective: executive function and memory will be tested with Cambridge Neuropsychological Test Automated Battery (CANTAB)
timeFrame: 1 year after baseline
measure: Change in cognitive function (follow up 2) - objective: executive function and memory will be tested with Cambridge Neuropsychological Test Automated Battery (CANTAB)
timeFrame: 1 year after follow up 1; 2 years after baseline
measure: Cognitive function (baseline) - subjective: Cognitive Failure Questionnaire
timeFrame: baseline
measure: Change in cognitive function (follow up 1) - subjective: Cognitive Failure Questionnaire
timeFrame: 1 year after baseline
measure: Change in cognitive function (follow up 2) - subjective: Cognitive Failure Questionnaire
timeFrame: 1 year after follow up 1; 2 years after baseline
measure: Sleep (baseline) - objective: accelerometery - characteristic 1: total sleep time
timeFrame: baseline
measure: Sleep (baseline) - objective: accelerometery - characteristic 2: wake after sleep onset
timeFrame: baseline
measure: Sleep (baseline) - objective: accelerometery - characteristic 3: sleep efficiency
timeFrame: baseline
measure: Sleep (baseline) - objective: accelerometery - characteristic 4: sleep latency
timeFrame: baseline
measure: Change in sleep (follow up 1) - objective: accelerometery - characteristic 1: total sleep time
timeFrame: 1 year after baseline
measure: Change in sleep (follow up 1) - objective: accelerometery - characteristic 2: wake after sleep onset
timeFrame: 1 year after baseline
measure: Change in sleep (follow up 1) - objective: accelerometery - characteristic 3: sleep efficiency
timeFrame: 1 year after baseline
measure: Change in sleep (follow up 1) - objective: accelerometery - characteristic 4: sleep latency
timeFrame: 1 year after baseline
measure: Change in sleep (follow up 2) - objective: accelerometery - characteristic 1: total sleep time
timeFrame: 1 year after follow up 1; 2 years after baseline
measure: Change in sleep (follow up 2) - objective: accelerometery - characteristic 2: wake after
timeFrame: 1 year after follow up 1; 2 years after baseline
measure: Change in sleep (follow up 2) - objective: accelerometery - characteristic 3: sleep efficiency
timeFrame: 1 year after follow up 1; 2 years after baseline
measure: Change in sleep (follow up 2) - objective: accelerometery - characteristic 4: sleep latency
timeFrame: 1 year after follow up 1; 2 years after baseline
measure: Sleep (baseline) - subjective: Pittsburgh Sleep Quality Index (PSQI)
timeFrame: Baseline
measure: Change in sleep (follow up 1) - subjective: Pittsburgh Sleep Quality Index (PSQI)
timeFrame: 1 year after baseline
measure: Change in sleep (follow up 2) - subjective: Pittsburgh Sleep Quality Index (PSQI)
timeFrame: 1 year after follow up 1; 2 years after baseline
measure: Physical activity & Sedentary behaviour (baseline) - objective: accelerometery 1
timeFrame: baseline
measure: Physical activity & Sedentary behaviour (baseline) - objective: accelerometery 2
timeFrame: baseline
measure: Change in Physical activity & Sedentary behaviour (follow up 1) - objective: accelerometery 1
timeFrame: 1 year after baseline
measure: Change in Physical activity & Sedentary behaviour (follow up 1) - objective: accelerometery 2
timeFrame: 1 year after baseline
measure: Change in Physical activity & Sedentary behaviour (follow up 2) - objective: accelerometery 1
timeFrame: 1 year after follow up 1; 2 years after baseline
measure: Change in Physical activity & Sedentary behaviour (follow up 2) - objective: accelerometery 2
timeFrame: 1 year after follow up 1; 2 years after baseline
measure: Physical activity & Sedentary behaviour (baseline) - subjective: International Physical Activity Questionnaire - Short Form (IPAQSF)
timeFrame: baseline
measure: Change in Physical activity & Sedentary behaviour (follow up 1) - subjective: International Physical Activity Questionnaire - Short Form (IPAQSF)
timeFrame: 1 year after baseline
measure: Change in Physical activity & Sedentary behaviour (follow up 2) - subjective: International Physical Activity Questionnaire - Short Form (IPAQSF)
timeFrame: 1 year after follow up 1; 2 years after baseline
measure: Physical activity (baseline) - subjective: muscle strengthening activity questionnaire
timeFrame: baseline
measure: Change in Physical activity (follow up 1) - subjective: muscle strengthening activity questionnaire
timeFrame: 1 year after baseline
measure: Change in Physical activity (follow up 2) - subjective: muscle strengthening activity questionnaire
timeFrame: 1 year after follow up 1; 2 years after baseline
Secondary outcomes:
measure: Wellbeing (baseline) - Warwick-Edinburgh Mental Wellbeing Scale (WEMWBS)
timeFrame: baseline
measure: Wellbeing (follow up 1) - Warwick-Edinburgh Mental Wellbeing Scale (WEMWBS)
timeFrame: 1 year after baseline
measure: Wellbeing (follow up 2) - Warwick-Edinburgh Mental Wellbeing Scale (WEMWBS)
timeFrame: 1 year after follow up 1; 2 years after baseline
measure: Global health (baseline) - PROMIS Global health
timeFrame: baseline
measure: Global health (baseline) - PROMIS Global health
timeFrame: 1 year after baseline
measure: Global health (follow up 2) - PROMIS Global health
timeFrame: 1 year after follow up 1; 2 years after baseline
measure: Depression (baseline) - The Geriatric Depression Scale (GDS-15)
timeFrame: baseline
measure: Depression (follow up 1) - The Geriatric Depression Scale (GDS-15)
timeFrame: 1 year after baseline
measure: Depression (follow up 2) - The Geriatric Depression Scale (GDS-15)
timeFrame: 1 year after follow up 1; 2 years after baseline
measure: Loneliness (baseline) - de Jong Gierveld loneliness scale (DJG loneliness)
timeFrame: baseline
measure: Loneliness (follow up 1) - de Jong Gierveld loneliness scale (DJG loneliness)
timeFrame: 1 year after baseline
measure: Loneliness (follow up 2) - de Jong Gierveld loneliness scale (DJG loneliness)
timeFrame: 1 year after follow up 1; 2 years after baseline
measure: Social network (baseline) - Lubben Social Network Scale (LSN-6)
timeFrame: baseline
measure: Social network (follow up 1) - Lubben Social Network Scale (LSN-6)
timeFrame: 1 year after baseline
measure: Social network (follow up 2) - Lubben Social Network Scale (LSN-6)
timeFrame: 1 year after follow up 1; 2 years after baseline
measure: Expectations Regarding Aging (baseline) - 12-Item Expectations Regarding Aging survey
timeFrame: baseline
measure: Expectations Regarding Aging (follow-up 1) - 12-Item Expectations Regarding Aging survey
timeFrame: 1 year after baseline
measure: Expectations Regarding Aging (follow-up 2) - 12-Item Expectations Regarding Aging survey
timeFrame: 1 year after follow up 1; 2 years after baseline
Other outcomes:
Locations:
city: Leuven
country: Belgium
facility: KU Leuven
state: Vlaams-Brabant
Study officials:
References: