Cognitively Enriched Walking Program

NCT05500183 | Unknown

• 1 other identifier: WALKYOURBRAIN
• Study Type: interventional
• Target: 113
• Locations: 1 country
• Sites: 2

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.

Conditions

Healthy Aging; Cognitive Decline; Physical Inactivity

Outcome Measures

Primary Outcomes (12)

• 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).

  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).

  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).

  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).

  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.

  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.

  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.

  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.

  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.

  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.

  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.

  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.

  12 months follow-up

Secondary Outcomes (20)

• Psychosocial wellbeing questionnaires T1

  baseline

• Psychosocial wellbeing questionnaires T2

  3 months follow-up

• Psychosocial wellbeing questionnaires T3

  6 months follow-up

• Psychosocial wellbeing questionnaires T4

  12 months follow-up

• Physical activity assessment (subjective) T1

  baseline

Other Outcomes (3)

• Process evaluation questionnaire T1

  baseline,3 months, 6 months follow-up

• Process evaluation questionnaire T2

  baseline,3 months, 6 months follow-up

• Process evaluation questionnaire T3

  baseline,3 months, 6 months follow-up

Study Arms (3)

PA + CA

EXPERIMENTAL

a cognitively enriched walking program (Physical Activity (PA)+Cognitive Activity (CA)

Behavioral: Cognitively enriched walking program

PA only

ACTIVE COMPARATOR

a walking program without cognitive enrichment (Physical Activity (PA) only)

Behavioral: walking program

control

NO INTERVENTION

a passive control group (CG). The passive CG will receive no intervention program.

Interventions

Cognitively enriched walking program BEHAVIORAL

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.

PA + CA

walking program BEHAVIORAL

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.

PA only

Eligibility Criteria

• Age: 65 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Older Adult (65+)

You may qualify if:

• male and female volunteers
• aged 65 years and older
• community-dwelling

You may not qualify if:

• 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).

Sponsors & Collaborators

• University Ghent: lead
• Research Foundation Flanders: collaborator
• KU Leuven: collaborator

Study Sites (2)

Ghent University

Ghent, East-Flanders, 9000, Belgium

RECRUITING

KU Leuven

Leuven, Vlaams Brabant, 3000, Belgium

RECRUITING

MeSH Terms

Conditions

Cognitive Dysfunction; Sedentary Behavior

Condition Hierarchy (Ancestors)

Cognition Disorders; Neurocognitive Disorders; Mental Disorders; Behavior

Study Officials

• Pauline Hotterbeex, MSc

  Ghent University / KU Leuven

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Greet Cardon, PhD

CONTACT

+32 9 264 91 42; Greet.Cardon@ugent.be

Jannique van Uffelen, PhD

CONTACT

jannique.vanuffelen@kuleuven.be

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 8, 2022
• First Posted: August 15, 2022
• Study Start: July 1, 2022
• Primary Completion: December 31, 2024
• Study Completion: December 31, 2024
• Last Updated: October 24, 2023

Record last verified: 2023-10

Data Sharing

• IPD Sharing: Will not share

Locations

BE (2)