Healthy AgingNCT05500183
Cognitively Enriched Walking Program
A study testing Cognitively enriched walking program and walking program in people with Healthy Aging and Cognitive Decline, run by University Ghent at 2 sites in Belgium.
Trial 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. Read more about this study
- Who is it for?
- Ages 65 years and olderHealthy volunteers can take part
- Conditions the study is for
- Healthy Aging, Cognitive Decline, Physical Inactivity
- What is being tested?
- Cognitively enriched walking program and walking program
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 113 participants
- Where
- 2 sitesBelgium
- Study dates
- 1 Jul 2022to 31 Dec 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 65 years and older
- All sexes
- Healthy volunteers accepted
- Older adult
Who may be able to join
- male and female volunteers
- aged 65 years and older
- community-dwelling
Who cannot join
- 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;
Show all 10Show fewer
- 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).
Trial locations and contacts
2 sites in 1 country.
Jannique van Uffelen, PhD contact
Belgium2 sites, 2 recruiting
- Recruiting
Ghent University
Ghent, East-Flanders, 9000
Melanie Beeckman, PhD, mebeeckm.beeckman@ugent.be
Greet Cardon, PhD, greet.cardon@ugent.be
- Recruiting
KU Leuven
Leuven, Vlaams Brabant, 3000
Pauline Hotterbeex, MSc, pauline.hotterbeex@kuleuven.be
Jannique van Uffelen, PhD, jannique.vanuffelen@kuleuven.be
About this study
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
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.
- Conditions
- Healthy Aging, Cognitive Decline, Physical Inactivity
- Being tested
- Cognitively enriched walking program, walking program
- Medical subject headings
- Cognitive Dysfunction, Sedentary Behavior
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cognitively enriched walking programBehavioural
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.
walking programBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| PA + CA | Experimental | a cognitively enriched walking program (Physical Activity (PA)+Cognitive Activity (CA) Receives: Behavioral: Cognitively enriched walking program |
| PA only | Active comparator | a walking program without cognitive enrichment (Physical Activity (PA) only) Receives: Behavioral: walking program |
| control | No intervention | a passive control group (CG). The passive CG will receive no intervention program. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: baseline
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).
Measured: 3 months follow-up
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).
Measured: 6 months follow-up
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).
Measured: 12 months follow-up
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.
Measured: baseline
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.
Measured: baseline
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.
Measured: 3 months follow-up
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.
Measured: 3 months follow-up
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.
Measured: 6 months follow-up
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.
Measured: 6 months follow-up
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.
Measured: 12 months follow-up
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.
Measured: 12 months follow-up
Secondary outcomes (20)
Psychosocial wellbeing questionnaires T1
(i.e., loneliness, social support, depressive symptomatology, positive wellbeing and expectations regarding aging)
Measured: baseline
Psychosocial wellbeing questionnaires T2
(i.e., loneliness, social support, depressive symptomatology, positive wellbeing and expectations regarding aging)
Measured: 3 months follow-up
Psychosocial wellbeing questionnaires T3
(i.e., loneliness, social support, depressive symptomatology, positive wellbeing and expectations regarding aging)
Measured: 6 months follow-up
Psychosocial wellbeing questionnaires T4
(i.e., loneliness, social support, depressive symptomatology, positive wellbeing and expectations regarding aging)
Measured: 12 months follow-up
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.
Measured: baseline
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.
Measured: baseline
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.
Measured: 3 months follow-up
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.
Measured: 3 months follow-up
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.
Measured: 6 months follow-up
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.
Measured: 6 months follow-up
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.
Measured: 12 months follow-up
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.
Measured: 12 months follow-up
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.
Measured: baseline
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.
Measured: baseline
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.
Measured: 3 months follow-up
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.
Measured: 3 months follow-up
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.
Measured: 6 months follow-up
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.
Measured: 6 months follow-up
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.
Measured: 12 months follow-up
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.
Measured: 12 months follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Aug 2022
- Study start1 Jul 2022
- Primary completion31 Dec 2024 (estimated)
- Study completion31 Dec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Healthy AgingStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 113 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Ghent
- Sponsor type
- University, hospital or other
- Collaborators
- Research Foundation Flanders, KU Leuven
- Responsible party
- Sponsor
- Investigators
- Pauline Hotterbeex, MSc, Principal investigator, Ghent University / KU Leuven
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05500183
- Sponsor's protocol ID
- WALKYOURBRAIN
- Status last verified
- Oct 2023
- First submitted
- 8 Jul 2022
- Last updated
- 24 Oct 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Hotterbeex P, Cardon G, Beeckman M, Latomme J, Fias W, van Puyenbroeck S, Chastin S, van Uffelen J. Does a Real-Life Cognitively Enriched Walking Program "Take a Walk With Your Brain" Benefit Cognitive Functioning and Physical Activity in Community-Dwelling Older Adults? A Randomized Controlled Trial. Gerontologist. 2025 May 10;65(6):gnaf043. doi: 10.1093/geront/gnaf043.
PubMed 39898431
Study at a glance
From the registry record, last updated by the sponsor on 24 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT05500183
- Acronym / sponsor ID
- WALKYOURBRAIN
- Conditions
- Healthy Aging, Cognitive Decline, Physical Inactivity
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 113 participants (estimated)
- Lead sponsor
- University GhentUniversity, hospital or other
- Collaborators
- Research Foundation Flanders, KU Leuven
- Study start
- 1 Jul 2022 (actual)
- Primary completion
- 31 Dec 2024 (estimated)
- Study completion
- 31 Dec 2024 (estimated)
- First posted
- 15 Aug 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| PA + CA | Experimental | Behavioral: Cognitively enriched walking programa cognitively enriched walking program (Physical Activity (PA)+Cognitive Activity (CA) |
| PA only | Active comparator | Behavioral: walking programa walking program without cognitive enrichment (Physical Activity (PA) only) |
| control | No intervention | –a passive control group (CG). The passive CG will receive no intervention program. |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Older adult
Key inclusion criteria (3 listed)
- male and female volunteers
- aged 65 years and older
- community-dwelling
Key exclusion criteria (10 listed)
- 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);
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Cognitively enriched walking programThe 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. | Behavioural | PA + CA |
| walking programThe 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. | Behavioural | PA only |
Primary outcome
objective cognitive functioning T1
Time frame: baseline
- 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
Time frame: 3 months follow-up
- 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
Time frame: 6 months follow-up
- 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
Time frame: 12 months follow-up
- 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
Time frame: baseline
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)
Time frame: baseline
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)
Time frame: 3 months follow-up
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)
Time frame: 3 months follow-up
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)
Time frame: 6 months follow-up
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)
Time frame: 6 months follow-up
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)
Time frame: 12 months follow-up
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)
Time frame: 12 months follow-up
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.
20 secondary outcomes
Psychosocial wellbeing questionnaires T1
Time frame: baseline
Psychosocial wellbeing questionnaires T2
Time frame: 3 months follow-up
Psychosocial wellbeing questionnaires T3
Time frame: 6 months follow-up
Psychosocial wellbeing questionnaires T4
Time frame: 12 months follow-up
Physical activity assessment (subjective) T1
Time frame: baseline
Physical activity assessment (objective) T1
Time frame: baseline
Physical activity assessment (subjective) T2
Time frame: 3 months follow-up
Physical activity assessment (objective) T2
Time frame: 3 months follow-up
Physical activity assessment (subjective) T3
Time frame: 6 months follow-up
Physical activity assessment (objective) T3
Time frame: 6 months follow-up
Physical activity assessment (subjective) T4
Time frame: 12 months follow-up
Physical activity assessment (objective) T4
Time frame: 12 months follow-up
General health questionnaires T1 - General Health
Time frame: baseline
General health questionnaires T1 - Sleep Disturbances
Time frame: baseline
General health questionnaires T2 - General Health
Time frame: 3 months follow-up
General health questionnaires T2 - Sleep Disturbances
Time frame: 3 months follow-up
General health questionnaires T3 - General Health
Time frame: 6 months follow-up
General health questionnaires T3 - Sleep Disturbances
Time frame: 6 months follow-up
General health questionnaires T4 - General Health
Time frame: 12 months follow-up
General health questionnaires T4 - Sleep Disturbances
Time frame: 12 months follow-up
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Oct 2023.
- Derived from this study: PubMed 39898431Hotterbeex P, Cardon G, Beeckman M, Latomme J, Fias W, van Puyenbroeck S, Chastin S, van Uffelen J. Does a Real-Life Cognitively Enriched Walking Program "Take a Walk With Your Brain" Benefit Cognitive Functioning and Physical Activity in Community-Dwelling Older Adults? A Randomized Controlled Trial. Gerontologist. 2025 May 10;65(6):gnaf043. doi: 10.1093/geront/gnaf043.
- Individual participant dataSharing planned: No
Related trials for Healthy Aging
RecruitingObservational study
Genetic and Epigenetic Signatures of Translational Aging Laboratory Testing (GESTALT)
Healthy Volunteers, Non-Healthy/Non-Frail
Not yet recruitingObservational study
China Healthy Aging and Fitness Longitudinal Study
Physical Fitness, Aging
Not yet recruiting
Effects of Increased Water Intake on Hormonal Response, Hydration Status, and Physical Function in Low-drinking Older Adults
Dehydrated, Water-Electrolyte Imbalance, Malnutrition, Dehydration (Physiology)
Not yet recruiting
Effects of Probiotics on Skin Health in Healthy Women
Skin Aging, Dry Skin
Not yet recruiting
Intervention Program for Psychological Well-Being in Institutionalized Older Adults Through Virtual Reality
Healthy Volunteers, Aging, Healthy
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jannique van Uffelen, PhD contact
Pauline Hotterbeex, MSc principal investigator
Ghent University / KU Leuven
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Cognitively enriched walking program and walking program in people with Healthy Aging and Cognitive Decline, run by University Ghent at 2 sites in Belgium.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 24 Oct 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Belgium. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Greet Cardon, PhD (+32 9 264 91 42, Greet.Cardon@ugent.be), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
objective cognitive functioning T1 (time frame: baseline). The study lists 12 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05500183, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Oct 2023.