Physiologic MonitoringNCT06893224
Can the Belgian Coastal Environment Improve Physical and Cognitive Health in Older Adults?
A study testing Coastal exposure and Urban exposure in people with Physiologic Monitoring and Self-report Questionnaire, run by University Ghent at 1 site in Belgium.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 60 years and olderHealthy volunteers can take part
- Conditions the study is for
- Physiologic Monitoring, Self-report Questionnaire, Sleep Quality
- What is being tested?
- Coastal exposure and Urban exposure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteBelgium
- Study dates
- 25 Sep 2024to 31 Dec 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 60 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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?
Read more
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).
Read the detailed description
Due to practical reasons regarding time, infrastructure and resources, the second phase with video exposure was cancelled. Furthermore, although randomization was initially planned, allocation to intervention order was ultimately determined by room availability constraints, resulting in a non-randomized design.
- Being tested
- Coastal exposure, Urban exposure
- Keywords
- Coastal environments, Older adults, Physiological stress, Cognitive function, Sleep quality
- Medical subject headings
- Sleep Initiation and Maintenance Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Coastal exposureOther
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.
Urban exposureOther
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.
| Study group | Role | What they receive |
|---|---|---|
| First a coastal exposure followed by an urban exposure | Experimental | 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. Receives: Other: Coastal exposure; Other: Urban exposure |
| First an urban exposure, followed by a coastal exposure | Experimental | 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. Receives: Other: Coastal exposure; Other: Urban exposure |
What is being measured
The primary outcome is the main question the study is designed to answer.
Heart rate variability - Time-domain measures
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.
Measured: For a period of 2,5 to 3 hours
Heart rate variability - Frequency-domain measures
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.
Measured: For a period of 2,5 to 3 hours
Electrodermal activity
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.
Measured: For a period of 2,5 to 3 hours
Salivary cortisol
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.
Measured: 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
Sustained attention - Total number of items processed
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.
Measured: Immediately before and immediately after the exposure to both environments (takes approximately 15 minutes)
Sustained attention - Performance
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.
Measured: Immediately before and immediately after the exposure to both environments (takes approximately 15 minutes)
Sustained attention - Error percentage
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.
Measured: Immediately before and immediately after the exposure to both environments (takes approximately 15 minutes)
Processing speed - Total correct responses
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.
Measured: Immediately before and immediately after the exposure to both environments (takes approximately 15 minutes)
Processing speed - Error rate
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.
Measured: Before and after the exposure to both environments (takes approximately 15 minutes)
Secondary outcomes (4)
Perceived stress
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").
Measured: Immediately before and after exposure to both environments
Perceived mental exhaustion
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").
Measured: Immediately before and after exposure to both environments
Positive mood and negative mood
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").
Measured: Immediately before and after exposure to both environments
Sleep quality
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.
Measured: 14 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Mar 2025
- Study start25 Sep 2024
- Primary completionDec 2026 (estimated)
- Study completion31 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Physiologic MonitoringStudies of the same condition, open and under way.
- More trials run by University GhentThe sponsor's other registered studies.
- 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
- Non-randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Ghent
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Mirko Petrovic, Principal investigator, University Ghent
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06893224
- Sponsor's protocol ID
- ONZ-2024-0225
- Status last verified
- Apr 2026
- First submitted
- 17 Feb 2025
- Last updated
- 14 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Can the Belgian Coastal Environment Boost Physical and Cognitive Health in Older Adults?
- ClinicalTrials.gov ID
- NCT06893224
- Acronym / sponsor ID
- ONZ-2024-0225
- Keywords
- Coastal environments, Older adults, Physiological stress, Cognitive function, Sleep quality
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- University GhentUniversity, hospital or other
- Study start
- 25 Sep 2024 (actual)
- Primary completion
- Dec 2026 (estimated)
- Study completion
- 31 Dec 2027 (estimated)
- First posted
- 25 Mar 2025 (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.
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).
Detailed description
Due to practical reasons regarding time, infrastructure and resources, the second phase with video exposure was cancelled. Furthermore, although randomization was initially planned, allocation to intervention order was ultimately determined by room availability constraints, resulting in a non-randomized design.
Study design
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| First a coastal exposure followed by an urban exposure | Experimental | Other: Coastal exposure, Other: Urban exposureParticipants 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. |
| First an urban exposure, followed by a coastal exposure | Experimental | Other: Coastal exposure, Other: Urban exposureParticipants 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. |
Who may qualify
- Ages
- 60 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (1 listed)
- 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.
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 |
|---|---|---|
| Coastal exposureThis 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. | Other | First a coastal exposure followed by an urban exposure, First an urban exposure, followed by a coastal exposure |
| Urban exposureThis 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. | Other | First a coastal exposure followed by an urban exposure, First an urban exposure, followed by a coastal exposure |
Primary outcome
Heart rate variability - Time-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. 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.
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.
Electrodermal activity
Time frame: For a period of 2,5 to 3 hours
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.
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
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.
Sustained attention - Total number of items processed
Time frame: Immediately before and immediately after the exposure to both environments (takes approximately 15 minutes)
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.
Sustained attention - Performance
Time frame: Immediately before and immediately after the exposure to both environments (takes approximately 15 minutes)
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.
Sustained attention - Error percentage
Time frame: Immediately before and immediately after the exposure to both environments (takes approximately 15 minutes)
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.
Processing speed - Total correct responses
Time frame: Immediately before and immediately after the exposure to both environments (takes approximately 15 minutes)
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.
Processing speed - Error rate
Time frame: Before and after the exposure to both environments (takes approximately 15 minutes)
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.
4 secondary outcomes
Perceived stress
Time frame: Immediately before and after exposure to both environments
Perceived mental exhaustion
Time frame: Immediately before and after exposure to both environments
Positive mood and negative mood
Time frame: Immediately before and after exposure to both environments
Sleep quality
Time frame: 14 days
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Apr 2026.
- Individual participant dataSharing planned: No
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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.
Mirko Petrovic principal investigator
University Ghent
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Coastal exposure and Urban exposure in people with Physiologic Monitoring and Self-report Questionnaire, run by University Ghent at 1 site 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 1 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: under way, not looking for participants, as of the sponsor's last update on 14 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Heart rate variability - Time-domain measures (time frame: For a period of 2,5 to 3 hours). The study lists 9 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 14 Apr 2026.