NCT07043205

Brief Summary

The literature suggests that natural environments, such as those on the Belgian coast, improve several psychological and physiological health parameters. In these environments, recreational activities often involve walking. However, it is still unknown how the effects of the environment and of walking together influence health. This study investigates the effects of a walk on the Belgian coast versus in the city on various psychological and physiological parameters of mental and physical health, both while walking and at rest after walking. A second set of research questions concerns the determination of the mediating roles of the physical activity performed, the other people in the environment, and environmental factors such as weather and perceived safety. This means that the investigators need to measure how these mediators differ between both environments, and to what extent these mediators have an impact on the subjects. A third set of research questions concerns the moderating roles of the individual characteristics (e.g. age, sex, SES personality, health) on the effects. 100 healthy Belgian adult subjects have to take a walk in both environments according to a within-subject cross-over design, while measurements are taken before, during, and after the walks. Before each walk there is also a walking session on a treadmill for baseline measurements, and rest periods before and during the walk to measure responses after the physical activity with the influence of the environment. The walk on the Belgian coast will take place in Ostend on the dike between the beach and the dunes, and the walk in the city will take place in Ghent center on a similar hard surface. A lot of physiological measurements will be done to determine the activity of the nervous systems and the HPA axis. More specifically, the heart rate will be derived from the electrocardiogram (ECG) as a general measure of the activation of the body and the high-frequency heart rate variability (HF-HRV) as a measure of the change in the activity of the parasympathetic nervous system. From a blood volume pulse signal (BVP) the mean arterial Pressure (MAP) will be derived as a general measure for the activation of the body and the blood circulation. From a skin conductance signal (EDA) the skin conductance level (SCL) and skin conductance responses (SCR) will be derived as measures of the activity of the sympathetic nervous system. From a respiration signal, respiration rate and depth will be derived as measures of regulation by the respiratory center in the brain. The average tone will be derived from the electromyogram (EMG) as a measure of musculoskeletal activation. These electrophysiological measurements will be made using sensors on the body and MindMedia's medically validated Nexus-10 MKII device. The activity of the HPA axis of stress will be measured by determining the concentration of the cortisol hormone in saliva. In addition, many questionnaires will be administered that measure the stress level, mood, psychological tension (arousal), worrying and rumination, mindfulness-related and subjective experiences of the participants. The investigators will closely monitor the mediating role of physical activity using a smartphone that will measure accelerometry, location and walking speed. The mediating roles of the other persons in the environment, the weather, and other environmental factors (e.g. naturalness) will be retrospectively questioned via post-walk questionnaires. It is not unimportant that many characteristics of the test subjects can respond to the effect sizes. That is why the investigators also ask for a lot of data about demographics, socio-economic status, lifestyle, health, personality, and other factors for the experiment. The hypothesis is that as a result of the physical activity, all physiological parameters of stress will increase, because physical activity affects the same physiological pathways as those of stress. The walk on the coast would increase the psychological and physiological differently than the walk in the urban environment. According to the literature, these effects should be are mediated by physical activity, other people in the vicinity, weather, and other environmental factors (e.g. perceived naturalness).

Trial Health

87
On Track

Trial Health Score

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

Enrollment
42

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Aug 2023

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

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 Start

First participant enrolled

August 2, 2023

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 11, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 11, 2023

Completed
1.2 years until next milestone

First Submitted

Initial submission to the registry

January 9, 2025

Completed
6 months until next milestone

First Posted

Study publicly available on registry

June 29, 2025

Completed
Last Updated

June 29, 2025

Status Verified

January 1, 2025

Enrollment Period

2 months

First QC Date

January 9, 2025

Last Update Submit

June 20, 2025

Conditions

Outcome Measures

Primary Outcomes (13)

  • Heart rate in number of beats per minute.

    Derived from electrocardiogram

    Monitored continuously. Outcome calculated for 2-minute intervals during the different stages of the experiment (i.e., baseline, during walk, during rest after walk; e.g., for two 2-minute intervals during 5-minute baseline).

  • High frequency hart rate variability with unit ms²

    Derived from electrocardiogram

    Monitored continuously. Outcome calculated for 2-minute intervals during the different stages of the experiment (i.e., baseline, during walk, during rest after walk; e.g., for two 2-minute intervals during 5-minute baseline).

  • Mean arterial blood pressure in unit µV

    Derived from blood volume pulse

    Monitored continuously. Outcome calculated for 2-minute intervals during the different stages of the experiment (i.e., baseline, during walk, during rest after walk; e.g., for two 2-minute intervals during 5-minute baseline).

  • Skin conductance level in µV

    Derived from skin conductance signal

    Monitored continuously. Outcome calculated for 2-minute intervals during the different stages of the experiment (i.e., baseline, during walk, during rest after walk; e.g., for two 2-minute intervals during 5-minute baseline).

  • Skin conductance response in muS

    Derived from skin conductance signal

    Monitored continuously. Outcome calculated for 2-minute intervals during the different stages of the experiment (i.e., baseline, during walk, during rest after walk; e.g., for two 2-minute intervals during 5-minute baseline).

  • Respiration rate (breaths/minute)

    Derived from respiration signal

    Monitored continuously. Outcome calculated for 2-minute intervals during the different stages of the experiment (i.e., baseline, during walk, during rest after walk; e.g., for two 2-minute intervals during 5-minute baseline).

  • Respiration depth in µV

    Derived from respiration signal

    Monitored continuously. Outcome calculated for 2-minute intervals during the different stages of the experiment (i.e., baseline, during walk, during rest after walk; e.g., for two 2-minute intervals during 5-minute baseline).

  • Average muscle tone in µV

    Derived from Electromyography

    Monitored continuously. Outcome calculated for 2-minute intervals during the different stages of the experiment (i.e., baseline, during walk, during rest after walk; e.g., for two 2-minute intervals during 5-minute baseline).

  • salivary cortisol concentration in nmol/l

    Derived from saliva

    Monitored continuously. Outcome calculated for 2-minute intervals during the different stages of the experiment (i.e., baseline, during walk, during rest after walk; e.g., for two 2-minute intervals during 5-minute baseline).

  • Stress level (1 item VAS 1-10, higher values mean more stress)

    Assessed via questionnaire

    Through study completion, an average of 2 hours

  • Positive mood (10 items, scale 1-5, larger is more positive mood)

    Assessed via questionnaire Positive and Negative Affect Scale (PANAS)

    Through study completion, an average of 2 hours

  • Negative mood (10 items, scale 1-5, larger is more negative mood)

    Assessed via questionnaire Positive and Negative Affect Scale (PANAS)

    Through study completion, an average of 2 hours

  • Arousal level (20 items, scale 1-4, larger is more arousal)

    Assessed via questionnaire Activation-Deactivation Adjective; AD ACL

    Through study completion, an average of 2 hours

Secondary Outcomes (3)

  • x, y, z accelerometry in m/s²

    Through study completion, an average of 2 hours

  • GPS location in coordinates

    Through study completion, an average of 2 hours

  • Walking speed in m/s

    Through study completion, an average of 2 hours

Other Outcomes (3)

  • Perceived naturalness of the environment (VAS, 1-10, higher is more natural)

    Through study completion, an average of 2 hours

  • Enjoyment of weather (VAS, 1-10, higher is more enjoying)

    Through study completion, an average of 2 hours

  • Enjoyment of other people in environment (VAS, 1-10, higher is more enjoying)

    Through study completion, an average of 2 hours

Study Arms (1)

40' walking

EXPERIMENTAL
Behavioral: Coastal walkBehavioral: Urban walk

Interventions

Coastal walkBEHAVIORAL

A 40-minute walk with psychophysiological monitoring in Ostend (along the beach)

40' walking
Urban walkBEHAVIORAL

40' walk in Ghent (urban)

40' walking

Eligibility Criteria

Age18 Years - 45 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • speaking dutch
  • years old
  • being a student or having a paid job
  • being able to walk for 1 hour

You may not qualify if:

  • not having a chronic mental or physical condition
  • not taking antidepressant drugs
  • not being pregnant
  • having no uncorrected sensory impairments

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Ghent University

Ghent, East-Flanders, 9000, Belgium

Location

Related Links

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 9, 2025

First Posted

June 29, 2025

Study Start

August 2, 2023

Primary Completion

October 11, 2023

Study Completion

October 11, 2023

Last Updated

June 29, 2025

Record last verified: 2025-01

Locations