NCT06893224

Brief 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 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).

Trial Health

75
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
20mo left

Started Sep 2024

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
active not recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress49%
Sep 2024Dec 2027

Study Start

First participant enrolled

September 25, 2024

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

February 17, 2025

Completed
1 month until next milestone

First Posted

Study publicly available on registry

March 25, 2025

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2026

Expected
1.1 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2027

Last Updated

April 14, 2026

Status Verified

April 1, 2026

Enrollment Period

2.2 years

First QC Date

February 17, 2025

Last Update Submit

April 8, 2026

Conditions

Keywords

Coastal environmentsOlder adultsPhysiological stressCognitive functionSleep quality

Outcome Measures

Primary Outcomes (9)

  • 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.

    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.

    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.

    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.

    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.

    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.

    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.

    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.

    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.

    Before and after the exposure to both environments (takes approximately 15 minutes)

Secondary Outcomes (4)

  • Perceived stress

    Immediately before and after exposure to both environments

  • Perceived mental exhaustion

    Immediately before and after exposure to both environments

  • Positive mood and negative mood

    Immediately before and after exposure to both environments

  • Sleep quality

    14 days

Study Arms (2)

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.

Other: Coastal exposureOther: 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.

Other: Coastal exposureOther: Urban exposure

Interventions

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.

First a coastal exposure followed by an urban exposureFirst an urban exposure, followed by a coastal exposure

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.

First a coastal exposure followed by an urban exposureFirst an urban exposure, followed by a coastal exposure

Eligibility Criteria

Age60 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Ghent University

Ghent, 9000, Belgium

Location

MeSH Terms

Conditions

Sleep Initiation and Maintenance Disorders

Condition Hierarchy (Ancestors)

Sleep Disorders, IntrinsicDyssomniasSleep Wake DisordersNervous System DiseasesMental Disorders

Study Officials

  • Mirko Petrovic

    University Ghent

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 17, 2025

First Posted

March 25, 2025

Study Start

September 25, 2024

Primary Completion (Estimated)

December 1, 2026

Study Completion (Estimated)

December 31, 2027

Last Updated

April 14, 2026

Record last verified: 2026-04

Data Sharing

IPD Sharing
Will not share

Locations