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临床试验/NCT05455229
NCT05455229已完成不适用

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

KU Leuven1 个研究点 分布在 1 个国家目标入组 260 人开始时间: 2021年7月22日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
KU Leuven
入组人数
260
试验地点
1
主要终点
Cognitive function (baseline) - subjective: Cognitive Failure Questionnaire

研究概览

简要总结

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.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

年龄范围
55 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Community dwelling, healthy adults aged 55 and above

排除标准

  • 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

结局指标

主要结局

Cognitive function (baseline) - subjective: Cognitive Failure Questionnaire

时间窗: baseline

25-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 Questionnaire

时间窗: 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.

Sleep (baseline) - objective: accelerometery - characteristic 2: wake after sleep onset

时间窗: 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.

Change in sleep (follow up 1) - objective: accelerometery - characteristic 1: total sleep time

时间窗: 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.

Change in sleep (follow up 2) - objective: accelerometery - characteristic 4: sleep latency

时间窗: 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.

Cognitive function (baseline) - objective: executive function and memory will be tested with Cambridge Neuropsychological Test Automated Battery (CANTAB)

时间窗: 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)

Change in cognitive function (follow up 2) - subjective: Cognitive Failure Questionnaire

时间窗: 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.

Change in sleep (follow up 1) - objective: accelerometery - characteristic 2: wake after sleep onset

时间窗: 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.

Change in sleep (follow up 2) - objective: accelerometery - characteristic 2: wake after

时间窗: 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.

Change in sleep (follow up 2) - objective: accelerometery - characteristic 3: sleep efficiency

时间窗: 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.

Change in Physical activity & Sedentary behaviour (follow up 1) - objective: accelerometery 1

时间窗: 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.

Change in cognitive function (follow up 1) - objective: executive function and memory will be tested with Cambridge Neuropsychological Test Automated Battery (CANTAB)

时间窗: 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)

Sleep (baseline) - objective: accelerometery - characteristic 1: total sleep time

时间窗: 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.

Change in sleep (follow up 1) - objective: accelerometery - characteristic 4: sleep latency

时间窗: 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.

Change in sleep (follow up 2) - objective: accelerometery - characteristic 1: total sleep time

时间窗: 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.

Change in sleep (follow up 1) - subjective: Pittsburgh Sleep Quality Index (PSQI)

时间窗: 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.

Physical activity & Sedentary behaviour (baseline) - objective: accelerometery 1

时间窗: 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.

Change in cognitive function (follow up 2) - objective: executive function and memory will be tested with Cambridge Neuropsychological Test Automated Battery (CANTAB)

时间窗: 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)

Sleep (baseline) - objective: accelerometery - characteristic 4: sleep latency

时间窗: 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.

Change in sleep (follow up 2) - subjective: Pittsburgh Sleep Quality Index (PSQI)

时间窗: 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.

Sleep (baseline) - objective: accelerometery - characteristic 3: sleep efficiency

时间窗: 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.

Change in sleep (follow up 1) - objective: accelerometery - characteristic 3: sleep efficiency

时间窗: 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.

Physical activity & Sedentary behaviour (baseline) - objective: accelerometery 2

时间窗: 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.

Sleep (baseline) - subjective: Pittsburgh Sleep Quality Index (PSQI)

时间窗: 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.

Change in Physical activity & Sedentary behaviour (follow up 1) - subjective: International Physical Activity Questionnaire - Short Form (IPAQSF)

时间窗: 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.

Change in Physical activity & Sedentary behaviour (follow up 1) - objective: accelerometery 2

时间窗: 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.

Change in Physical activity & Sedentary behaviour (follow up 2) - objective: accelerometery 1

时间窗: 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.

Change in Physical activity & Sedentary behaviour (follow up 2) - subjective: International Physical Activity Questionnaire - Short Form (IPAQSF)

时间窗: 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.

Physical activity (baseline) - subjective: muscle strengthening activity questionnaire

时间窗: 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.

Change in Physical activity (follow up 1) - subjective: muscle strengthening activity questionnaire

时间窗: 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.

Change in Physical activity (follow up 2) - subjective: muscle strengthening activity questionnaire

时间窗: 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.

Change in Physical activity & Sedentary behaviour (follow up 2) - objective: accelerometery 2

时间窗: 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.

Physical activity & Sedentary behaviour (baseline) - subjective: International Physical Activity Questionnaire - Short Form (IPAQSF)

时间窗: 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.

次要结局

  • Social network (baseline) - Lubben Social Network Scale (LSN-6)(baseline)
  • Expectations Regarding Aging (baseline) - 12-Item Expectations Regarding Aging survey(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(1 year after baseline)
  • Loneliness (baseline) - de Jong Gierveld loneliness scale (DJG loneliness)(baseline)
  • Wellbeing (baseline) - Warwick-Edinburgh Mental Wellbeing Scale (WEMWBS)(baseline)
  • Global health (follow up 2) - PROMIS Global health(1 year after follow up 1; 2 years after baseline)
  • Depression (baseline) - The Geriatric Depression Scale (GDS-15)(baseline)
  • Loneliness (follow up 1) - de Jong Gierveld loneliness scale (DJG loneliness)(1 year after baseline)
  • Social network (follow up 1) - Lubben Social Network Scale (LSN-6)(1 year after baseline)
  • Depression (follow up 2) - The Geriatric Depression Scale (GDS-15)(1 year after follow up 1; 2 years after baseline)
  • Expectations Regarding Aging (follow-up 2) - 12-Item Expectations Regarding Aging survey(1 year after follow up 1; 2 years after baseline)
  • Depression (follow up 1) - The Geriatric Depression Scale (GDS-15)(1 year after baseline)
  • Loneliness (follow up 2) - de Jong Gierveld loneliness scale (DJG loneliness)(1 year after follow up 1; 2 years after baseline)
  • Social network (follow up 2) - Lubben Social Network Scale (LSN-6)(1 year after follow up 1; 2 years after baseline)
  • Expectations Regarding Aging (follow-up 1) - 12-Item Expectations Regarding Aging survey(1 year after baseline)

研究者

发起方
KU Leuven
申办方类型
Other
责任方
Principal Investigator
主要研究者

Pieter-Jan Marent

Principal Investigator

KU Leuven

研究点 (1)

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