- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06893224
Can the Belgian Coastal Environment Improve Physical and Cognitive Health in Older Adults?
Can the Belgian Coastal Environment Boost Physical and Cognitive Health in Older Adults?
The goal of this interventional study is to learn if exposure to coastal environments improves the physical and cognitive health of older adults over the age of 60. The main questions it aims to answer are:
Does coastal exposure affect physical stress levels in older adults? Does coastal exposure affect self-reported stress levels in older adults? Does coastal exposure affect cognitive measures, such as sustained attention, in older adults? Does coastal exposure affect sleep quality in older adults? Is there a difference between the various components of coastal environments (e.g. dykes, dunes,...) in their effect on older adults' physical stress?
This wil be a within-subject study, in which participants get exposed to both a coastal and an urban environment to compare their response to these environments.
Participants will perform a coastal and urban walk on different days, equipped with wearable sensors (namely a wrist- and chestband) to measure various parameters such as heart rate and skin conductivity. Before, during and after the walk saliva samples will be collected for cortisol analysis. Before and after the walks they will also answer some questions (on e.g. overall demographics but also self-reported mental health) and perform cognitive tests (to study e.g. sustained attention).
Study Overview
Status
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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-
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Ghent, Belgium, 9000
- Ghent University
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
You are willing to make the time needed to complete the experiment. You understand and can communicate in Dutch. You are 60 years or older and retired. You are familiar with the city of Ostend. This means you visit Ostend multiple times per year and are preferably familiar with the area around the Grote Post and Fort Napoleon.
You smoke no more than 10 cigarettes per day. You are able and comfortable walking for approximately 30 minutes at an average pace without aids such as a cane or walker.
You do not have a pacemaker. You are not blind or deaf. You do not take tricyclic antidepressants or clozapine.
Exclusion Criteria:
People who cannot participate in the entire experiment, do not speak Dutch, are under 60 years old or not yet retired, have a pacemaker, are blind or deaf, take tricyclic antidepressants or clozapine, are not at all familiar with the city of Ostend, smoke more than 10 cigarettes per day, or are unable to walk for 30 minutes continuously without aids are not eligible to participate in the experiment.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Non-Randomized
- Interventional Model: Crossover Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
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Experimental: First a coastal exposure followed by an urban exposure
Participants assigned to this arm will first perform a coastal exposure (15 minutes of seated exposure, followed by 30 minute-walk), followed by an urban exposure a week later.
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This is a "real-life" exposure to the coastal environment, in which participants walk to a bench, sit there for 15 minutes, followed by a walk of approximately 30 minutes.
After the 15 minute sitting period, a saliva sample is collected.
During the walk, participants are equipped with wearable sensors.
The walking route is indicated on a map.
This is a "real-life" exposure to the urban environment, in which participants walk to a bench, sit there for 15 minutes, followed by a walk of approximately 30 minutes.
After the 15 minute sitting period, a saliva sample is collected.
During the walk, participants are equipped with wearable sensors.
The walking route is indicated on a map.
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|
Experimental: First an urban exposure, followed by a coastal exposure
Participants assigned to this arm will first perform an urban exposure (15 minutes of seated exposure, followed by 30 minute-walk), followed by a coastal exposure a week later.
|
This is a "real-life" exposure to the coastal environment, in which participants walk to a bench, sit there for 15 minutes, followed by a walk of approximately 30 minutes.
After the 15 minute sitting period, a saliva sample is collected.
During the walk, participants are equipped with wearable sensors.
The walking route is indicated on a map.
This is a "real-life" exposure to the urban environment, in which participants walk to a bench, sit there for 15 minutes, followed by a walk of approximately 30 minutes.
After the 15 minute sitting period, a saliva sample is collected.
During the walk, participants are equipped with wearable sensors.
The walking route is indicated on a map.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Heart rate variability - Time-domain measures
Time Frame: For a period of 2,5 to 3 hours
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During the entire protocol, both in the first and second phases of the study, interbeat intervals (IBIs) will be recorded using the Polar H10 chestband.
From these IBIs, heart rate variability (HRV) measures will be calculated.
Time-domain measures will be expressed in milliseconds (ms), including SDNN (Standard Deviation of NN intervals) and RMSSD (Root Mean Square of Successive Differences).
These parameters provide insight into autonomic nervous system activity, particularly parasympathetic modulation.
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For a period of 2,5 to 3 hours
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Heart rate variability - Frequency-domain measures
Time Frame: For a period of 2,5 to 3 hours
|
During the entire protocol, both in the first and second phases of the study, interbeat intervals (IBIs) will be recorded using the Polar H10 chestband.
From these IBIs, heart rate variability (HRV) measures will be calculated.
Frequency-domain measures, including low-frequency (LF) power, high-frequency (HF) power (expressed in milliseconds squared [ms²] or normalized units [nu]), and the LF/HF ratio (unitless), will be analyzed.
These parameters provide insight into autonomic nervous system activity, with HF power primarily reflecting parasympathetic modulation and the LF/HF ratio indicating the balance between sympathetic and parasympathetic influences.
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For a period of 2,5 to 3 hours
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Electrodermal activity
Time Frame: For a period of 2,5 to 3 hours
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Electrodermal activity (EDA) of participants will be measured using the EmbracePlus wristband.
EDA will be continuously recorded throughout the entire protocol, both during the first and second phases of the study.
The primary EDA outcome measures include skin conductance level (SCL) and skin conductance responses (SCRs), both expressed in microsiemens (µS), These parameters provide insight into sympathetic nervous system activity and arousal dynamics.
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For a period of 2,5 to 3 hours
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Salivary cortisol
Time Frame: At 4 time points: before the exposure (baseline), after the seated exposure of 15 minutes, right after the walk, and 20 minutes after the walk
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Saliva samples will be collected in the first phase of the study, at 4 time points: before the exposure (baseline), after the seated exposure of 15 minutes, right after the walk, and 20 minutes after the walk.
These saliva samples will be analysed for the presence of cortisol, which is expressed in nmol/L.
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At 4 time points: before the exposure (baseline), after the seated exposure of 15 minutes, right after the walk, and 20 minutes after the walk
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Sustained attention - Total number of items processed
Time Frame: Immediately before and immediately after the exposure to both environments (takes approximately 15 minutes)
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Sustained attention will be measured immediately before and after exposure to both environments, in both phases of the study.
The validated d2 test of attention will be used for this.
One outcome of this test is the total number of items processed (TN).
This represents the total number of stimuli (letters) that a participant has scanned and attempted to process within the given time, with higher numbers indicating better sustained attention.
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Immediately before and immediately after the exposure to both environments (takes approximately 15 minutes)
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Sustained attention - Performance
Time Frame: Immediately before and immediately after the exposure to both environments (takes approximately 15 minutes)
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Sustained attention will be measured immediately before and after exposure to both environments, in both phases of the study.
The validated d2 test of attention will be used for this.
Another outcome of this test is the performance (P).
This is calculated as the number of correctly marked target stimuli minus the number of errors (including both commission and omission errors).
The higher this performance score, the better the participants' sustained attention.
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Immediately before and immediately after the exposure to both environments (takes approximately 15 minutes)
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Sustained attention - Error percentage
Time Frame: Immediately before and immediately after the exposure to both environments (takes approximately 15 minutes)
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Sustained attention will be measured immediately before and after exposure to both environments, in both phases of the study.
The validated d2 test of attention will be used for this.
Another outcome of this test is error percentage.
This indicates the percentage of errors relative to the total number of marked items.
Errors can be divided into: 1) commission errors (false positives) and 2) ommission errors (false negatives).
Commision errors represent the incorrectly marked symbols that are not target stimuli.
The ommission errors are the target stimuli that weren't marked.
The lower the error percentage, the better participants' sustained attention.
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Immediately before and immediately after the exposure to both environments (takes approximately 15 minutes)
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Processing speed - Total correct responses
Time Frame: Immediately before and immediately after the exposure to both environments (takes approximately 15 minutes)
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Processing speed will be measured immediately before and after exposure to both environments, in both phases of the study.
The validated Symbol Digit Modalities Test will be used for this.
One outcome measure is the number of total correct responses.
This is the number of correct symbol-digit pairings made within the given time limit.
The higher this number, the better participants' processing speed.
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Immediately before and immediately after the exposure to both environments (takes approximately 15 minutes)
|
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Processing speed - Error rate
Time Frame: Before and after the exposure to both environments (takes approximately 15 minutes)
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Processing speed will be measured immediately before and after exposure to both environments, in both phases of the study.
The validated Symbol Digit Modalities Test will be used for this.
Another outcome measure of this test is the error rate, which is the number of incorrect responses.
The lower the error rate, the better for participants' processing speed.
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Before and after the exposure to both environments (takes approximately 15 minutes)
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Perceived stress
Time Frame: Immediately before and after exposure to both environments
|
Perceived stress will be evaluated immediately before and after exposure to both environments.
This will be measured using one question asking the participant "How stressed are you now?", which has to be scored on a ten-point Likert scale ranging from 1 (labelled "Not at all stressed") to 10 (labelled "Totally stressed").
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Immediately before and after exposure to both environments
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Perceived mental exhaustion
Time Frame: Immediately before and after exposure to both environments
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Perceived mental exhaustion will be evaluated immediately before and after exposure to both environments.
This will be measured using one question asking the participant "How mentally exhausted are you now?", which has to be scored on a ten-point Likert scale ranging from 1 (labelled "Not mentally exhausted at all") to 10 (labelled "Totally mentally exhausted").
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Immediately before and after exposure to both environments
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Positive mood and negative mood
Time Frame: Immediately before and after exposure to both environments
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Positive mood will be evaluated immediately before and after exposure to both environments.
This will be measured using the "Positive and Negative Affect Schedule".
Participants will have to indicate to what extent they experience each of the emotions or feelings listed on a scale ranging from 1 (labelled "Very slightly or not at all") to 5 (labelled "Extremely").
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Immediately before and after exposure to both environments
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Sleep quality
Time Frame: 14 days
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In the first phase of the study, participants will keep a sleeping diary for 14 days, to see whether the exposures to the different environments have an effect on their sleep quality.
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14 days
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Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Mirko Petrovic, University Ghent
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- ONZ-2024-0225
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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