Cognitively Enriched Walking Program
Primary Purpose
Healthy Aging, Cognitive Decline, Physical Inactivity
Status
Recruiting
Phase
Not Applicable
Locations
Belgium
Study Type
Interventional
Intervention
Cognitively enriched walking program
walking program
Sponsored by
About this trial
This is an interventional prevention trial for Healthy Aging
Eligibility Criteria
Inclusion Criteria:
- male and female volunteers
- aged 65 years and older
- community-dwelling
Exclusion Criteria:
- Have a neurodegenerative disorder (i.e. Alzheimer's disease, Parkinson's disease, Multiple Sclerosis,…);
- Are diagnosed with mild cognitive impairment (MCI);
- Are diagnosed with a psychiatric disorder (e.g. schizophrenia, bipolar disorder, borderline personality disorder,…);
- Are currently having a depressive episode;
- Have had a serious brain injury in the past year, or before and still experience consequences (i.e. traumatic brain injury, stroke, brain haemorrhage);
- Have a history of, or current, addiction to drugs or excessive alcohol abuse;
- Are not able to walk approximately three kilometres in one hour (at an average walking pace);
- Make use of a walking aid (i.e. a cane, a (rollator) walker, or a wheelchair);
- One or both of their parents were diagnosed with juvenile dementia;
- Know in advance that they will not be will not be present for one or more periods of longer than one month (e.g. because of a long holiday).
Sites / Locations
- Ghent UniversityRecruiting
- KU LeuvenRecruiting
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Active Comparator
No Intervention
Arm Label
PA + CA
PA only
control
Arm Description
a cognitively enriched walking program (Physical Activity (PA)+Cognitive Activity (CA)
a walking program without cognitive enrichment (Physical Activity (PA) only)
a passive control group (CG). The passive CG will receive no intervention program.
Outcomes
Primary Outcome Measures
objective cognitive functioning T1
- Cambridge Neuropsychological Test Automated Battery (CANTAB) (Bento-Torres et al., 2017; Sahakian & Owen, 1992; Zygouris & Tsolaki, 2015): objective cognitive functioning is assessed with CANTAB. Different tests can be configured in a test battery, based on the focus of the study. The tests are non-verbal and culturally independent and make use of touchscreen technology. The CANTAB has been shown sensitive to changes in cognitive performance. Six different tests were selected to obtain a comprehensive view of one's objective cognitive functioning. The selected tests assess attention (i.e. sustained attention), memory (i.e. visual episodic attention and short term visual memory) and executive functioning (i.e. working memory and strategy).
objective cognitive functioning T2
- Cambridge Neuropsychological Test Automated Battery (CANTAB) (Bento-Torres et al., 2017; Sahakian & Owen, 1992; Zygouris & Tsolaki, 2015): objective cognitive functioning is assessed with CANTAB. Different tests can be configured in a test battery, based on the focus of the study. The tests are non-verbal and culturally independent and make use of touchscreen technology. The CANTAB has been shown sensitive to changes in cognitive performance. Six different tests were selected to obtain a comprehensive view of one's objective cognitive functioning. The selected tests assess attention (i.e. sustained attention), memory (i.e. visual episodic attention and short term visual memory) and executive functioning (i.e. working memory and strategy).
objective cognitive functioning T3
- Cambridge Neuropsychological Test Automated Battery (CANTAB) (Bento-Torres et al., 2017; Sahakian & Owen, 1992; Zygouris & Tsolaki, 2015): objective cognitive functioning is assessed with CANTAB. Different tests can be configured in a test battery, based on the focus of the study. The tests are non-verbal and culturally independent and make use of touchscreen technology. The CANTAB has been shown sensitive to changes in cognitive performance. Six different tests were selected to obtain a comprehensive view of one's objective cognitive functioning. The selected tests assess attention (i.e. sustained attention), memory (i.e. visual episodic attention and short term visual memory) and executive functioning (i.e. working memory and strategy).
cognitive functioning T4
- Cambridge Neuropsychological Test Automated Battery (CANTAB) (Bento-Torres et al., 2017; Sahakian & Owen, 1992; Zygouris & Tsolaki, 2015): objective cognitive functioning is assessed with CANTAB. Different tests can be configured in a test battery, based on the focus of the study. The tests are non-verbal and culturally independent and make use of touchscreen technology. The CANTAB has been shown sensitive to changes in cognitive performance. Six different tests were selected to obtain a comprehensive view of one's objective cognitive functioning. The selected tests assess attention (i.e. sustained attention), memory (i.e. visual episodic attention and short term visual memory) and executive functioning (i.e. working memory and strategy).
subjective cognitive functioning T1 - Cognitive Failures Questionnaire
Cognitive Failures Questionnaire (CFQ) (Broadbent et al., 1982; Ponds et al., 2006): this self-administered questionnaire assesses subjective cognitive functioning. Participants are asked about minor everyday slips or errors. It is not a replacement for testing objective cognitive functioning, but reflects the experience of the frequency of everyday slips of the participant.
The CFQ consists of 25 items. Participants have to rate the items on a five-point response scale going from "1" (very ofen) to "5" (never). Higher scores reflect less cognitive failure.
subjective cognitive functioning T1 - Cognitive and Leisure Activities Scale (CLAS)
Cognitive and Leisure Activities Scale (CLAS) (Galvin et al., 2021): this is a measure of the type and frequency of cognitive activities. It includes sixteen types of cognitive activities and is self-administered. Even though it is difficult to establish the validity of this new questionnaire since there is no gold standard to measure cognitive activity, it is suggested that this questionnaire has a good content validity.
The CLAS consists of 16 items that are scored on a five-point response scale, going from 0 "never" to 5 "daily". Higher scores reflect a higher frequency of doing the activity.
subjective cognitive functioning T2 - Cognitive Failures Questionnaire (CFQ)
Cognitive Failures Questionnaire (CFQ) (Broadbent et al., 1982; Ponds et al., 2006): this self-administered questionnaire assesses subjective cognitive functioning. Participants are asked about minor everyday slips or errors. It is not a replacement for testing objective cognitive functioning, but reflects the experience of the frequency of everyday slips of the participant.
subjective cognitive functioning T2 - Cognitive and Leisure Activities Scale (CLAS)
Cognitive and Leisure Activities Scale (CLAS) (Galvin et al., 2021): this is a measure of the type and frequency of cognitive activities. It includes sixteen types of cognitive activities and is self-administered. Even though it is difficult to establish the validity of this new questionnaire since there is no gold standard to measure cognitive activity, it is suggested that this questionnaire has a good content validity.
The CLAS consists of 16 items that are scored on a five-point response scale, going from 0 "never" to 5 "daily". Higher scores reflect a higher frequency of doing the activity.
subjective cognitive functioning T3 - Cognitive Failures Questionnaire (CFQ)
Cognitive Failures Questionnaire (CFQ) (Broadbent et al., 1982; Ponds et al., 2006): this self-administered questionnaire assesses subjective cognitive functioning. Participants are asked about minor everyday slips or errors. It is not a replacement for testing objective cognitive functioning, but reflects the experience of the frequency of everyday slips of the participant.
The CFQ consists of 25 items. Participants have to rate the items on a five-point response scale going from "1" (very ofen) to "5" (never). Higher scores reflect less cognitive failure.
subjective cognitive functioning T3 - Cognitive and Leisure Activities Scale (CLAS)
Cognitive and Leisure Activities Scale (CLAS)(Galvin et al., 2021): this is a measure of the type and frequency of cognitive activities. It includes sixteen types of cognitive activities and is self-administered. Even though it is difficult to establish the validity of this new questionnaire since there is no gold standard to measure cognitive activity, it is suggested that this questionnaire has a good content validity.
The CLAS consists of 16 items that are scored on a five-point response scale, going from 0 "never" to 5 "daily". Higher scores reflect a higher frequency of doing the activity.
subjective cognitive functioning T4 - Cognitive Failures Questionnaire (CFQ)
Cognitive Failures Questionnaire (CFQ) (Broadbent et al., 1982; Ponds et al., 2006): this self-administered questionnaire assesses subjective cognitive functioning. Participants are asked about minor everyday slips or errors. It is not a replacement for testing objective cognitive functioning, but reflects the experience of the frequency of everyday slips of the participant.
The CFQ consists of 25 items. Participants have to rate the items on a five-point response scale going from "1" (very ofen) to "5" (never). Higher scores reflect less cognitive failure.
subjective cognitive functioning T4 - Cognitive and Leisure Activities Scale (CLAS)
Cognitive and Leisure Activities Scale (CLAS) (Galvin et al., 2021): this is a measure of the type and frequency of cognitive activities. It includes sixteen types of cognitive activities and is self-administered. Even though it is difficult to establish the validity of this new questionnaire since there is no gold standard to measure cognitive activity, it is suggested that this questionnaire has a good content validity.
The CLAS consists of 16 items that are scored on a five-point response scale, going from 0 "never" to 5 "daily". Higher scores reflect a higher frequency of doing the activity.
Secondary Outcome Measures
Psychosocial wellbeing questionnaires T1
(i.e., loneliness, social support, depressive symptomatology, positive wellbeing and expectations regarding aging)
Psychosocial wellbeing questionnaires T2
(i.e., loneliness, social support, depressive symptomatology, positive wellbeing and expectations regarding aging)
Psychosocial wellbeing questionnaires T3
(i.e., loneliness, social support, depressive symptomatology, positive wellbeing and expectations regarding aging)
Psychosocial wellbeing questionnaires T4
(i.e., loneliness, social support, depressive symptomatology, positive wellbeing and expectations regarding aging)
Physical activity assessment (subjective) T1
International Physical Activity Questionnaire - Short Form (IPAQ-SF) (Craig et al., 2003): this is an extensively used self-report measure for physical activity during the past seven days. It provides us with a categorical score of physical activity, distinguishing between low, moderate and high levels of physical activity.
Physical activity assessment (objective) T1
Actigraph accelerometer at hip (Barnett et al., 2016): this is an objective measure of physical activity level, frequently used in physical activity studies with older adults. Participants will be asked to wear this accelerometer during seven days (day and night). They will be asked to register when and why they did not wear the device in a personal diary provided by the researchers.
Physical activity assessment (subjective) T2
International Physical Activity Questionnaire - Short Form (IPAQ-SF) (Craig et al., 2003): this is an extensively used self-report measure for physical activity during the past seven days. It provides us with a categorical score of physical activity, distinguishing between low, moderate and high levels of physical activity.
Physical activity assessment (objective) T2
Actigraph accelerometer at hip (Barnett et al., 2016): this is an objective measure of physical activity level, frequently used in physical activity studies with older adults. Participants will be asked to wear this accelerometer during seven days (day and night). They will be asked to register when and why they did not wear the device in a personal diary provided by the researchers.
Physical activity assessment (subjective) T3
International Physical Activity Questionnaire - Short Form (IPAQ-SF) (Craig et al., 2003): this is an extensively used self-report measure for physical activity during the past seven days. It provides us with a categorical score of physical activity, distinguishing between low, moderate and high levels of physical activity.
Physical activity assessment (objective) T3
Actigraph accelerometer at hip (Barnett et al., 2016): this is an objective measure of physical activity level, frequently used in physical activity studies with older adults. Participants will be asked to wear this accelerometer during seven days (day and night). They will be asked to register when and why they did not wear the device in a personal diary provided by the researchers.
Physical activity assessment (subjective) T4
International Physical Activity Questionnaire - Short Form (IPAQ-SF) (Craig et al., 2003): this is an extensively used self-report measure for physical activity during the past seven days. It provides us with a categorical score of physical activity, distinguishing between low, moderate and high levels of physical activity.
Physical activity assessment (objective) T4
Actigraph accelerometer at hip (Barnett et al., 2016): this is an objective measure of physical activity level, frequently used in physical activity studies with older adults. Participants will be asked to wear this accelerometer during seven days (day and night). They will be asked to register when and why they did not wear the device in a personal diary provided by the researchers.
General health questionnaires T1 - General Health
The Patient-Reported Outcomes Measurement Information System (PROMIS) eight-item short form for General Health (Pellicciari et al., 2021): this is a self-report measure for global self-rated health with acceptable psychometric properties. This questionnaire provides us with a total score as well as distinct scores for mental and physical health.
Scoring
PROMIS uses a T-score metric in which 50 is the mean of a relevant reference population and 10 is the standard deviation (SD) of that population.
A score of 40 is one SD lower than the mean of the reference population. A score of 60 is one SD higher than the mean of the reference population.
For PROMIS measures, higher scores equals more of the concept being measured.
General health questionnaires T1 - Sleep Disturbances
The Patient-Reported Outcomes Measurement Information System (PROMIS) four-item short form for Sleep Disturbances (Buysse et al., 2010; Terwee et al., 2014): this self-report measure with good psychometric properties assesses quality of sleep and prevalence of sleep difficulties.
Scoring
PROMIS uses a T-score metric in which 50 is the mean of a relevant reference population and 10 is the standard deviation (SD) of that population.
A score of 40 is one SD lower than the mean of the reference population. A score of 60 is one SD higher than the mean of the reference population.
For PROMIS measures, higher scores equals more of the concept being measured.
General health questionnaires T2 - General Health
The Patient-Reported Outcomes Measurement Information System (PROMIS) eight-item short form for General Health (Pellicciari et al., 2021): this is a self-report measure for global self-rated health with acceptable psychometric properties. This questionnaire provides us with a total score as well as distinct scores for mental and physical health.
Scoring
PROMIS uses a T-score metric in which 50 is the mean of a relevant reference population and 10 is the standard deviation (SD) of that population.
A score of 40 is one SD lower than the mean of the reference population. A score of 60 is one SD higher than the mean of the reference population.
For PROMIS measures, higher scores equals more of the concept being measured.
General health questionnaires T2 - Sleep Disturbances
The Patient-Reported Outcomes Measurement Information System (PROMIS) four-item short form for Sleep Disturbances (Buysse et al., 2010; Terwee et al., 2014): this self-report measure with good psychometric properties assesses quality of sleep and prevalence of sleep difficulties.
Scoring
PROMIS uses a T-score metric in which 50 is the mean of a relevant reference population and 10 is the standard deviation (SD) of that population.
A score of 40 is one SD lower than the mean of the reference population. A score of 60 is one SD higher than the mean of the reference population.
For PROMIS measures, higher scores equals more of the concept being measured.
General health questionnaires T3 - General Health
The Patient-Reported Outcomes Measurement Information System (PROMIS) eight-item short form for General Health (Pellicciari et al., 2021): this is a self-report measure for global self-rated health with acceptable psychometric properties. This questionnaire provides us with a total score as well as distinct scores for mental and physical health.
Scoring
PROMIS uses a T-score metric in which 50 is the mean of a relevant reference population and 10 is the standard deviation (SD) of that population.
A score of 40 is one SD lower than the mean of the reference population. A score of 60 is one SD higher than the mean of the reference population.
For PROMIS measures, higher scores equals more of the concept being measured.
General health questionnaires T3 - Sleep Disturbances
The Patient-Reported Outcomes Measurement Information System (PROMIS) four-item short form for Sleep Disturbances (Buysse et al., 2010; Terwee et al., 2014): this self-report measure with good psychometric properties assesses quality of sleep and prevalence of sleep difficulties.
Scoring
PROMIS uses a T-score metric in which 50 is the mean of a relevant reference population and 10 is the standard deviation (SD) of that population.
A score of 40 is one SD lower than the mean of the reference population. A score of 60 is one SD higher than the mean of the reference population.
For PROMIS measures, higher scores equals more of the concept being measured.
General health questionnaires T4 - General Health
The Patient-Reported Outcomes Measurement Information System (PROMIS) eight-item short form for General Health (Pellicciari et al., 2021): this is a self-report measure for global self-rated health with acceptable psychometric properties. This questionnaire provides us with a total score as well as distinct scores for mental and physical health.
Scoring
PROMIS uses a T-score metric in which 50 is the mean of a relevant reference population and 10 is the standard deviation (SD) of that population.
A score of 40 is one SD lower than the mean of the reference population. A score of 60 is one SD higher than the mean of the reference population.
For PROMIS measures, higher scores equals more of the concept being measured.
General health questionnaires T4 - Sleep Disturbances
The Patient-Reported Outcomes Measurement Information System (PROMIS) four-item short form for Sleep Disturbances (Buysse et al., 2010; Terwee et al., 2014): this self-report measure with good psychometric properties assesses quality of sleep and prevalence of sleep difficulties.
Scoring
PROMIS uses a T-score metric in which 50 is the mean of a relevant reference population and 10 is the standard deviation (SD) of that population.
A score of 40 is one SD lower than the mean of the reference population. A score of 60 is one SD higher than the mean of the reference population.
For PROMIS measures, higher scores equals more of the concept being measured.
Full Information
NCT ID
NCT05500183
First Posted
July 8, 2022
Last Updated
October 20, 2023
Sponsor
University Ghent
Collaborators
Research Foundation Flanders, KU Leuven
1. Study Identification
Unique Protocol Identification Number
NCT05500183
Brief Title
Cognitively Enriched Walking Program
Official Title
Evaluating the Effects of a Cognitively Enriched Walking Program for Older Adults on Cognitive Functioning, Psychosocial Wellbeing and Physical Activity: a Randomized Controlled Trial
Study Type
Interventional
2. Study Status
Record Verification Date
October 2023
Overall Recruitment Status
Recruiting
Study Start Date
July 1, 2022 (Actual)
Primary Completion Date
December 31, 2024 (Anticipated)
Study Completion Date
December 31, 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Ghent
Collaborators
Research Foundation Flanders, KU Leuven
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
Brief Summary
Dementia currently affects more than 47 million people worldwide, its prevalence is forecasted to triple by 2050, and it has been reported to be one of the most costly disorders in Belgium. There is good scientific evidence that the cognitive impairments associated with the development of dementia can be lessened or even reversed thanks to the plasticity of the brain (rewiring). Recent research has shown that physical activity combined with performing cognitively challenging tasks is a very potent way to induce this rewiring of the brain, which can enable people to improve their cognitive functions. Yet, so far, these studies are mainly limited to controlled laboratory conditions. The investigators developed a real-life cognitively enriched walking program, with input from experts and end-users. In this study, the investigators will examine the added value of enriching physical activity (walking) with cognitive exercises in improving cognition of older adults by conducting a six-month community-based randomized controlled trial. The investigators will also examine the longer term effectiveness in a follow-up measurement visit six months after the program. The investigators will focus on the following outcomes: cognitive functioning (i.e., objective, subjective and cognitive activity), psychosocial wellbeing (i.e., loneliness, social support, depressive symptomatology, positive wellbeing and expectations regarding aging), physical activity (i.e. both objective and subjective) and general health.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Healthy Aging, Cognitive Decline, Physical Inactivity
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
113 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
PA + CA
Arm Type
Experimental
Arm Description
a cognitively enriched walking program (Physical Activity (PA)+Cognitive Activity (CA)
Arm Title
PA only
Arm Type
Active Comparator
Arm Description
a walking program without cognitive enrichment (Physical Activity (PA) only)
Arm Title
control
Arm Type
No Intervention
Arm Description
a passive control group (CG). The passive CG will receive no intervention program.
Intervention Type
Behavioral
Intervention Name(s)
Cognitively enriched walking program
Intervention Description
The PA+CA program is group-based and will have a duration of six months (i.e. 24 weeks), with a frequency of two group sessions a week. All group sessions will last for approximately one hour and take place in groups of twelve or thirteen people supervised by a certified coach. Participants will be encouraged to do one individual session every week, as well.
Intervention Type
Behavioral
Intervention Name(s)
walking program
Intervention Description
The PA only program is group-based and will have a duration of six months (i.e. 24 weeks), with a frequency of two group sessions a week. All group sessions will last for approximately one hour and take place in groups of twelve or thirteen people supervised by a certified coach. Participants will be encouraged to do one individual session every week, as well.
Primary Outcome Measure Information:
Title
objective cognitive functioning T1
Description
- Cambridge Neuropsychological Test Automated Battery (CANTAB) (Bento-Torres et al., 2017; Sahakian & Owen, 1992; Zygouris & Tsolaki, 2015): objective cognitive functioning is assessed with CANTAB. Different tests can be configured in a test battery, based on the focus of the study. The tests are non-verbal and culturally independent and make use of touchscreen technology. The CANTAB has been shown sensitive to changes in cognitive performance. Six different tests were selected to obtain a comprehensive view of one's objective cognitive functioning. The selected tests assess attention (i.e. sustained attention), memory (i.e. visual episodic attention and short term visual memory) and executive functioning (i.e. working memory and strategy).
Time Frame
baseline
Title
objective cognitive functioning T2
Description
- Cambridge Neuropsychological Test Automated Battery (CANTAB) (Bento-Torres et al., 2017; Sahakian & Owen, 1992; Zygouris & Tsolaki, 2015): objective cognitive functioning is assessed with CANTAB. Different tests can be configured in a test battery, based on the focus of the study. The tests are non-verbal and culturally independent and make use of touchscreen technology. The CANTAB has been shown sensitive to changes in cognitive performance. Six different tests were selected to obtain a comprehensive view of one's objective cognitive functioning. The selected tests assess attention (i.e. sustained attention), memory (i.e. visual episodic attention and short term visual memory) and executive functioning (i.e. working memory and strategy).
Time Frame
3 months follow-up
Title
objective cognitive functioning T3
Description
- Cambridge Neuropsychological Test Automated Battery (CANTAB) (Bento-Torres et al., 2017; Sahakian & Owen, 1992; Zygouris & Tsolaki, 2015): objective cognitive functioning is assessed with CANTAB. Different tests can be configured in a test battery, based on the focus of the study. The tests are non-verbal and culturally independent and make use of touchscreen technology. The CANTAB has been shown sensitive to changes in cognitive performance. Six different tests were selected to obtain a comprehensive view of one's objective cognitive functioning. The selected tests assess attention (i.e. sustained attention), memory (i.e. visual episodic attention and short term visual memory) and executive functioning (i.e. working memory and strategy).
Time Frame
6 months follow-up
Title
cognitive functioning T4
Description
- Cambridge Neuropsychological Test Automated Battery (CANTAB) (Bento-Torres et al., 2017; Sahakian & Owen, 1992; Zygouris & Tsolaki, 2015): objective cognitive functioning is assessed with CANTAB. Different tests can be configured in a test battery, based on the focus of the study. The tests are non-verbal and culturally independent and make use of touchscreen technology. The CANTAB has been shown sensitive to changes in cognitive performance. Six different tests were selected to obtain a comprehensive view of one's objective cognitive functioning. The selected tests assess attention (i.e. sustained attention), memory (i.e. visual episodic attention and short term visual memory) and executive functioning (i.e. working memory and strategy).
Time Frame
12 months follow-up
Title
subjective cognitive functioning T1 - Cognitive Failures Questionnaire
Description
Cognitive Failures Questionnaire (CFQ) (Broadbent et al., 1982; Ponds et al., 2006): this self-administered questionnaire assesses subjective cognitive functioning. Participants are asked about minor everyday slips or errors. It is not a replacement for testing objective cognitive functioning, but reflects the experience of the frequency of everyday slips of the participant.
The CFQ consists of 25 items. Participants have to rate the items on a five-point response scale going from "1" (very ofen) to "5" (never). Higher scores reflect less cognitive failure.
Time Frame
baseline
Title
subjective cognitive functioning T1 - Cognitive and Leisure Activities Scale (CLAS)
Description
Cognitive and Leisure Activities Scale (CLAS) (Galvin et al., 2021): this is a measure of the type and frequency of cognitive activities. It includes sixteen types of cognitive activities and is self-administered. Even though it is difficult to establish the validity of this new questionnaire since there is no gold standard to measure cognitive activity, it is suggested that this questionnaire has a good content validity.
The CLAS consists of 16 items that are scored on a five-point response scale, going from 0 "never" to 5 "daily". Higher scores reflect a higher frequency of doing the activity.
Time Frame
baseline
Title
subjective cognitive functioning T2 - Cognitive Failures Questionnaire (CFQ)
Description
Cognitive Failures Questionnaire (CFQ) (Broadbent et al., 1982; Ponds et al., 2006): this self-administered questionnaire assesses subjective cognitive functioning. Participants are asked about minor everyday slips or errors. It is not a replacement for testing objective cognitive functioning, but reflects the experience of the frequency of everyday slips of the participant.
Time Frame
3 months follow-up
Title
subjective cognitive functioning T2 - Cognitive and Leisure Activities Scale (CLAS)
Description
Cognitive and Leisure Activities Scale (CLAS) (Galvin et al., 2021): this is a measure of the type and frequency of cognitive activities. It includes sixteen types of cognitive activities and is self-administered. Even though it is difficult to establish the validity of this new questionnaire since there is no gold standard to measure cognitive activity, it is suggested that this questionnaire has a good content validity.
The CLAS consists of 16 items that are scored on a five-point response scale, going from 0 "never" to 5 "daily". Higher scores reflect a higher frequency of doing the activity.
Time Frame
3 months follow-up
Title
subjective cognitive functioning T3 - Cognitive Failures Questionnaire (CFQ)
Description
Cognitive Failures Questionnaire (CFQ) (Broadbent et al., 1982; Ponds et al., 2006): this self-administered questionnaire assesses subjective cognitive functioning. Participants are asked about minor everyday slips or errors. It is not a replacement for testing objective cognitive functioning, but reflects the experience of the frequency of everyday slips of the participant.
The CFQ consists of 25 items. Participants have to rate the items on a five-point response scale going from "1" (very ofen) to "5" (never). Higher scores reflect less cognitive failure.
Time Frame
6 months follow-up
Title
subjective cognitive functioning T3 - Cognitive and Leisure Activities Scale (CLAS)
Description
Cognitive and Leisure Activities Scale (CLAS)(Galvin et al., 2021): this is a measure of the type and frequency of cognitive activities. It includes sixteen types of cognitive activities and is self-administered. Even though it is difficult to establish the validity of this new questionnaire since there is no gold standard to measure cognitive activity, it is suggested that this questionnaire has a good content validity.
The CLAS consists of 16 items that are scored on a five-point response scale, going from 0 "never" to 5 "daily". Higher scores reflect a higher frequency of doing the activity.
Time Frame
6 months follow-up
Title
subjective cognitive functioning T4 - Cognitive Failures Questionnaire (CFQ)
Description
Cognitive Failures Questionnaire (CFQ) (Broadbent et al., 1982; Ponds et al., 2006): this self-administered questionnaire assesses subjective cognitive functioning. Participants are asked about minor everyday slips or errors. It is not a replacement for testing objective cognitive functioning, but reflects the experience of the frequency of everyday slips of the participant.
The CFQ consists of 25 items. Participants have to rate the items on a five-point response scale going from "1" (very ofen) to "5" (never). Higher scores reflect less cognitive failure.
Time Frame
12 months follow-up
Title
subjective cognitive functioning T4 - Cognitive and Leisure Activities Scale (CLAS)
Description
Cognitive and Leisure Activities Scale (CLAS) (Galvin et al., 2021): this is a measure of the type and frequency of cognitive activities. It includes sixteen types of cognitive activities and is self-administered. Even though it is difficult to establish the validity of this new questionnaire since there is no gold standard to measure cognitive activity, it is suggested that this questionnaire has a good content validity.
The CLAS consists of 16 items that are scored on a five-point response scale, going from 0 "never" to 5 "daily". Higher scores reflect a higher frequency of doing the activity.
Time Frame
12 months follow-up
Secondary Outcome Measure Information:
Title
Psychosocial wellbeing questionnaires T1
Description
(i.e., loneliness, social support, depressive symptomatology, positive wellbeing and expectations regarding aging)
Time Frame
baseline
Title
Psychosocial wellbeing questionnaires T2
Description
(i.e., loneliness, social support, depressive symptomatology, positive wellbeing and expectations regarding aging)
Time Frame
3 months follow-up
Title
Psychosocial wellbeing questionnaires T3
Description
(i.e., loneliness, social support, depressive symptomatology, positive wellbeing and expectations regarding aging)
Time Frame
6 months follow-up
Title
Psychosocial wellbeing questionnaires T4
Description
(i.e., loneliness, social support, depressive symptomatology, positive wellbeing and expectations regarding aging)
Time Frame
12 months follow-up
Title
Physical activity assessment (subjective) T1
Description
International Physical Activity Questionnaire - Short Form (IPAQ-SF) (Craig et al., 2003): this is an extensively used self-report measure for physical activity during the past seven days. It provides us with a categorical score of physical activity, distinguishing between low, moderate and high levels of physical activity.
Time Frame
baseline
Title
Physical activity assessment (objective) T1
Description
Actigraph accelerometer at hip (Barnett et al., 2016): this is an objective measure of physical activity level, frequently used in physical activity studies with older adults. Participants will be asked to wear this accelerometer during seven days (day and night). They will be asked to register when and why they did not wear the device in a personal diary provided by the researchers.
Time Frame
baseline
Title
Physical activity assessment (subjective) T2
Description
International Physical Activity Questionnaire - Short Form (IPAQ-SF) (Craig et al., 2003): this is an extensively used self-report measure for physical activity during the past seven days. It provides us with a categorical score of physical activity, distinguishing between low, moderate and high levels of physical activity.
Time Frame
3 months follow-up
Title
Physical activity assessment (objective) T2
Description
Actigraph accelerometer at hip (Barnett et al., 2016): this is an objective measure of physical activity level, frequently used in physical activity studies with older adults. Participants will be asked to wear this accelerometer during seven days (day and night). They will be asked to register when and why they did not wear the device in a personal diary provided by the researchers.
Time Frame
3 months follow-up
Title
Physical activity assessment (subjective) T3
Description
International Physical Activity Questionnaire - Short Form (IPAQ-SF) (Craig et al., 2003): this is an extensively used self-report measure for physical activity during the past seven days. It provides us with a categorical score of physical activity, distinguishing between low, moderate and high levels of physical activity.
Time Frame
6 months follow-up
Title
Physical activity assessment (objective) T3
Description
Actigraph accelerometer at hip (Barnett et al., 2016): this is an objective measure of physical activity level, frequently used in physical activity studies with older adults. Participants will be asked to wear this accelerometer during seven days (day and night). They will be asked to register when and why they did not wear the device in a personal diary provided by the researchers.
Time Frame
6 months follow-up
Title
Physical activity assessment (subjective) T4
Description
International Physical Activity Questionnaire - Short Form (IPAQ-SF) (Craig et al., 2003): this is an extensively used self-report measure for physical activity during the past seven days. It provides us with a categorical score of physical activity, distinguishing between low, moderate and high levels of physical activity.
Time Frame
12 months follow-up
Title
Physical activity assessment (objective) T4
Description
Actigraph accelerometer at hip (Barnett et al., 2016): this is an objective measure of physical activity level, frequently used in physical activity studies with older adults. Participants will be asked to wear this accelerometer during seven days (day and night). They will be asked to register when and why they did not wear the device in a personal diary provided by the researchers.
Time Frame
12 months follow-up
Title
General health questionnaires T1 - General Health
Description
The Patient-Reported Outcomes Measurement Information System (PROMIS) eight-item short form for General Health (Pellicciari et al., 2021): this is a self-report measure for global self-rated health with acceptable psychometric properties. This questionnaire provides us with a total score as well as distinct scores for mental and physical health.
Scoring
PROMIS uses a T-score metric in which 50 is the mean of a relevant reference population and 10 is the standard deviation (SD) of that population.
A score of 40 is one SD lower than the mean of the reference population. A score of 60 is one SD higher than the mean of the reference population.
For PROMIS measures, higher scores equals more of the concept being measured.
Time Frame
baseline
Title
General health questionnaires T1 - Sleep Disturbances
Description
The Patient-Reported Outcomes Measurement Information System (PROMIS) four-item short form for Sleep Disturbances (Buysse et al., 2010; Terwee et al., 2014): this self-report measure with good psychometric properties assesses quality of sleep and prevalence of sleep difficulties.
Scoring
PROMIS uses a T-score metric in which 50 is the mean of a relevant reference population and 10 is the standard deviation (SD) of that population.
A score of 40 is one SD lower than the mean of the reference population. A score of 60 is one SD higher than the mean of the reference population.
For PROMIS measures, higher scores equals more of the concept being measured.
Time Frame
baseline
Title
General health questionnaires T2 - General Health
Description
The Patient-Reported Outcomes Measurement Information System (PROMIS) eight-item short form for General Health (Pellicciari et al., 2021): this is a self-report measure for global self-rated health with acceptable psychometric properties. This questionnaire provides us with a total score as well as distinct scores for mental and physical health.
Scoring
PROMIS uses a T-score metric in which 50 is the mean of a relevant reference population and 10 is the standard deviation (SD) of that population.
A score of 40 is one SD lower than the mean of the reference population. A score of 60 is one SD higher than the mean of the reference population.
For PROMIS measures, higher scores equals more of the concept being measured.
Time Frame
3 months follow-up
Title
General health questionnaires T2 - Sleep Disturbances
Description
The Patient-Reported Outcomes Measurement Information System (PROMIS) four-item short form for Sleep Disturbances (Buysse et al., 2010; Terwee et al., 2014): this self-report measure with good psychometric properties assesses quality of sleep and prevalence of sleep difficulties.
Scoring
PROMIS uses a T-score metric in which 50 is the mean of a relevant reference population and 10 is the standard deviation (SD) of that population.
A score of 40 is one SD lower than the mean of the reference population. A score of 60 is one SD higher than the mean of the reference population.
For PROMIS measures, higher scores equals more of the concept being measured.
Time Frame
3 months follow-up
Title
General health questionnaires T3 - General Health
Description
The Patient-Reported Outcomes Measurement Information System (PROMIS) eight-item short form for General Health (Pellicciari et al., 2021): this is a self-report measure for global self-rated health with acceptable psychometric properties. This questionnaire provides us with a total score as well as distinct scores for mental and physical health.
Scoring
PROMIS uses a T-score metric in which 50 is the mean of a relevant reference population and 10 is the standard deviation (SD) of that population.
A score of 40 is one SD lower than the mean of the reference population. A score of 60 is one SD higher than the mean of the reference population.
For PROMIS measures, higher scores equals more of the concept being measured.
Time Frame
6 months follow-up
Title
General health questionnaires T3 - Sleep Disturbances
Description
The Patient-Reported Outcomes Measurement Information System (PROMIS) four-item short form for Sleep Disturbances (Buysse et al., 2010; Terwee et al., 2014): this self-report measure with good psychometric properties assesses quality of sleep and prevalence of sleep difficulties.
Scoring
PROMIS uses a T-score metric in which 50 is the mean of a relevant reference population and 10 is the standard deviation (SD) of that population.
A score of 40 is one SD lower than the mean of the reference population. A score of 60 is one SD higher than the mean of the reference population.
For PROMIS measures, higher scores equals more of the concept being measured.
Time Frame
6 months follow-up
Title
General health questionnaires T4 - General Health
Description
The Patient-Reported Outcomes Measurement Information System (PROMIS) eight-item short form for General Health (Pellicciari et al., 2021): this is a self-report measure for global self-rated health with acceptable psychometric properties. This questionnaire provides us with a total score as well as distinct scores for mental and physical health.
Scoring
PROMIS uses a T-score metric in which 50 is the mean of a relevant reference population and 10 is the standard deviation (SD) of that population.
A score of 40 is one SD lower than the mean of the reference population. A score of 60 is one SD higher than the mean of the reference population.
For PROMIS measures, higher scores equals more of the concept being measured.
Time Frame
12 months follow-up
Title
General health questionnaires T4 - Sleep Disturbances
Description
The Patient-Reported Outcomes Measurement Information System (PROMIS) four-item short form for Sleep Disturbances (Buysse et al., 2010; Terwee et al., 2014): this self-report measure with good psychometric properties assesses quality of sleep and prevalence of sleep difficulties.
Scoring
PROMIS uses a T-score metric in which 50 is the mean of a relevant reference population and 10 is the standard deviation (SD) of that population.
A score of 40 is one SD lower than the mean of the reference population. A score of 60 is one SD higher than the mean of the reference population.
For PROMIS measures, higher scores equals more of the concept being measured.
Time Frame
12 months follow-up
Other Pre-specified Outcome Measures:
Title
Process evaluation questionnaire T1
Description
This will include questions on fidelity, delivered dose (completeness), received dose (exposure, satisfaction), participation rate, acceptability of the intervention, group dynamics, environmental context,…
Time Frame
baseline,3 months, 6 months follow-up
Title
Process evaluation questionnaire T2
Description
This will include questions on fidelity, delivered dose (completeness), received dose (exposure, satisfaction), participation rate, acceptability of the intervention, group dynamics, environmental context,…
Time Frame
baseline,3 months, 6 months follow-up
Title
Process evaluation questionnaire T3
Description
This will include questions on fidelity, delivered dose (completeness), received dose (exposure, satisfaction), participation rate, acceptability of the intervention, group dynamics, environmental context,…
Time Frame
baseline,3 months, 6 months follow-up
10. Eligibility
Sex
All
Minimum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
male and female volunteers
aged 65 years and older
community-dwelling
Exclusion Criteria:
Have a neurodegenerative disorder (i.e. Alzheimer's disease, Parkinson's disease, Multiple Sclerosis,…);
Are diagnosed with mild cognitive impairment (MCI);
Are diagnosed with a psychiatric disorder (e.g. schizophrenia, bipolar disorder, borderline personality disorder,…);
Are currently having a depressive episode;
Have had a serious brain injury in the past year, or before and still experience consequences (i.e. traumatic brain injury, stroke, brain haemorrhage);
Have a history of, or current, addiction to drugs or excessive alcohol abuse;
Are not able to walk approximately three kilometres in one hour (at an average walking pace);
Make use of a walking aid (i.e. a cane, a (rollator) walker, or a wheelchair);
One or both of their parents were diagnosed with juvenile dementia;
Know in advance that they will not be will not be present for one or more periods of longer than one month (e.g. because of a long holiday).
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Greet Cardon, PhD
Phone
+32 9 264 91 42
Email
Greet.Cardon@ugent.be
First Name & Middle Initial & Last Name or Official Title & Degree
Jannique van Uffelen, PhD
Email
jannique.vanuffelen@kuleuven.be
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Pauline Hotterbeex, MSc
Organizational Affiliation
Ghent University / KU Leuven
Official's Role
Principal Investigator
Facility Information:
Facility Name
Ghent University
City
Ghent
State/Province
East-Flanders
ZIP/Postal Code
9000
Country
Belgium
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Melanie Beeckman, PhD
Email
mebeeckm.beeckman@ugent.be
First Name & Middle Initial & Last Name & Degree
Greet Cardon, PhD
Email
greet.cardon@ugent.be
First Name & Middle Initial & Last Name & Degree
Melanie Beeckman, PhD
Facility Name
KU Leuven
City
Leuven
State/Province
Vlaams Brabant
ZIP/Postal Code
3000
Country
Belgium
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Pauline Hotterbeex, MSc
Email
pauline.hotterbeex@kuleuven.be
First Name & Middle Initial & Last Name & Degree
Jannique van Uffelen, PhD
Email
jannique.vanuffelen@kuleuven.be
First Name & Middle Initial & Last Name & Degree
Pauline Hotterbeex, MSc
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Cognitively Enriched Walking Program
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