Clinical trial NCT05500183: 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
Overall status: RECRUITING
Phase: NA
Conditions: Healthy Aging
Cognitive Decline
Physical Inactivity
Lead sponsor: University Ghent
Sponsor class: OTHER
Collaborators: name: Research Foundation Flanders
name: KU Leuven
First posted: 2022-08-15
Enrollment: 113
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.


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).

Primary outcomes:
measure: objective cognitive functioning T1
timeFrame: baseline
measure: objective cognitive functioning T2
timeFrame: 3 months follow-up
measure: objective cognitive functioning T3
timeFrame: 6 months follow-up
measure: cognitive functioning T4
timeFrame: 12 months follow-up
measure: subjective cognitive functioning T1 - Cognitive Failures Questionnaire
timeFrame: baseline
measure: subjective cognitive functioning T1 - Cognitive and Leisure Activities Scale (CLAS)
timeFrame: baseline
measure: subjective cognitive functioning T2 - Cognitive Failures Questionnaire (CFQ)
timeFrame: 3 months follow-up
measure: subjective cognitive functioning T2 - Cognitive and Leisure Activities Scale (CLAS)
timeFrame: 3 months follow-up
measure: subjective cognitive functioning T3 - Cognitive Failures Questionnaire (CFQ)
timeFrame: 6 months follow-up
measure: subjective cognitive functioning T3 - Cognitive and Leisure Activities Scale (CLAS)
timeFrame: 6 months follow-up
measure: subjective cognitive functioning T4 - Cognitive Failures Questionnaire (CFQ)
timeFrame: 12 months follow-up
measure: subjective cognitive functioning T4 - Cognitive and Leisure Activities Scale (CLAS)
timeFrame: 12 months follow-up
Secondary outcomes:
measure: Psychosocial wellbeing questionnaires T1
timeFrame: baseline
measure: Psychosocial wellbeing questionnaires T2
timeFrame: 3 months follow-up
measure: Psychosocial wellbeing questionnaires T3
timeFrame: 6 months follow-up
measure: Psychosocial wellbeing questionnaires T4
timeFrame: 12 months follow-up
measure: Physical activity assessment (subjective) T1
timeFrame: baseline
measure: Physical activity assessment (objective) T1
timeFrame: baseline
measure: Physical activity assessment (subjective) T2
timeFrame: 3 months follow-up
measure: Physical activity assessment (objective) T2
timeFrame: 3 months follow-up
measure: Physical activity assessment (subjective) T3
timeFrame: 6 months follow-up
measure: Physical activity assessment (objective) T3
timeFrame: 6 months follow-up
measure: Physical activity assessment (subjective) T4
timeFrame: 12 months follow-up
measure: Physical activity assessment (objective) T4
timeFrame: 12 months follow-up
measure: General health questionnaires T1 - General Health
timeFrame: baseline
measure: General health questionnaires T1 - Sleep Disturbances
timeFrame: baseline
measure: General health questionnaires T2 - General Health
timeFrame: 3 months follow-up
measure: General health questionnaires T2 - Sleep Disturbances
timeFrame: 3 months follow-up
measure: General health questionnaires T3 - General Health
timeFrame: 6 months follow-up
measure: General health questionnaires T3 - Sleep Disturbances
timeFrame: 6 months follow-up
measure: General health questionnaires T4 - General Health
timeFrame: 12 months follow-up
measure: General health questionnaires T4 - Sleep Disturbances
timeFrame: 12 months follow-up
Other outcomes:
measure: Process evaluation questionnaire T1
timeFrame: baseline,3 months, 6 months follow-up
measure: Process evaluation questionnaire T2
timeFrame: baseline,3 months, 6 months follow-up
measure: Process evaluation questionnaire T3
timeFrame: baseline,3 months, 6 months follow-up
Locations:
city: Ghent
country: Belgium
facility: Ghent University
state: East-Flanders
city: Leuven
country: Belgium
facility: KU Leuven
state: Vlaams Brabant
Study officials:
affiliation: Ghent University / KU Leuven
name: Pauline Hotterbeex, MSc
role: PRINCIPAL_INVESTIGATOR
References: