Cognitively Enriched Walking Program

NCT ID: NCT05500183

Last Updated: 2023-10-24

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 113 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-07-01
• Study Completion Date: 2024-12-31

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: DOUBLE

Study Groups

PA + CA

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

Group Type: EXPERIMENTAL

Cognitively enriched walking program

Intervention Type: 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 only

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

Group Type: ACTIVE_COMPARATOR

walking program

Intervention Type: 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.

control

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

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Cognitively enriched walking program

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

walking program

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.

Intervention Type: BEHAVIORAL

Eligibility Criteria

Inclusion Criteria

1. male and female volunteers

2. aged 65 years and older

3. community-dwelling

Exclusion Criteria

1. Have a neurodegenerative disorder (i.e. Alzheimer's disease, Parkinson's disease, Multiple Sclerosis,…);

2. Are diagnosed with mild cognitive impairment (MCI);

3. Are diagnosed with a psychiatric disorder (e.g. schizophrenia, bipolar disorder, borderline personality disorder,…);

4. Are currently having a depressive episode;

5. Have had a serious brain injury in the past year, or before and still experience consequences (i.e. traumatic brain injury, stroke, brain haemorrhage);

6. Have a history of, or current, addiction to drugs or excessive alcohol abuse;

7. Are not able to walk approximately three kilometres in one hour (at an average walking pace);

8. Make use of a walking aid (i.e. a cane, a (rollator) walker, or a wheelchair);

9. One or both of their parents were diagnosed with juvenile dementia;

10. 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).

• Minimum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Research Foundation Flanders

OTHER

Sponsor Role: collaborator

KU Leuven

OTHER

Sponsor Role: collaborator

University Ghent

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Pauline Hotterbeex, MSc

Role: PRINCIPAL_INVESTIGATOR

Ghent University / KU Leuven

Locations

Ghent University

Ghent, East-Flanders, Belgium

Site Status: RECRUITING

KU Leuven

Leuven, Vlaams Brabant, Belgium

Site Status: RECRUITING

Countries

Belgium

Central Contacts

Greet Cardon, PhD

Role: CONTACT

Greet.Cardon@ugent.be

+32 9 264 91 42

Jannique van Uffelen, PhD

Role: CONTACT

jannique.vanuffelen@kuleuven.be

Facility Contacts

Melanie Beeckman, PhD

Role: primary

mebeeckm.beeckman@ugent.be

Greet Cardon, PhD

Role: backup

greet.cardon@ugent.be

Pauline Hotterbeex, MSc

Role: primary

pauline.hotterbeex@kuleuven.be

Jannique van Uffelen, PhD

Role: backup

jannique.vanuffelen@kuleuven.be

Other Identifiers

WALKYOURBRAIN

Identifier Type: -

Identifier Source: org_study_id