NCT07114146

Brief Summary

Natural environments, and more specifically forest environments, have shown in the last decade a growing interest as a protection against the frenetic pace of life of a large part of the urban population in developed countries, where symptoms related to stress and anxiety are associated with an increasingly frequent state of sub-health. The investigators propose to perform a randomized crossover study to analyze the effects of a walk in the forest on physiological and psychological markers related to autonomic nervous system activity in healthy adult. In addition, the investigators intend to observe whether the characteristics and perceptions of the forest environment could affect the results obtained in these markers using a scale created for this purpose. Participants will be healthy adults with no history of serious physical or psychological illnesses, who will be exposed to three forest environments. Physiological markers will be measured, including heart rate variability, which will be measured with a heart rate sensor that will monitor data throughout the exposure period, and heart rate and systolic and diastolic blood pressure, which will be measured with an automated device before and after each exposure. Before and after the walk through each of the forest environments, mood will be measured using the POMS scale, and our scale will be used to measure the perceived environmental quality after exposure to each environment. In addition to the walk through the three forest environments, a control environment on an indoor treadmill will be used as a comparator, where distance, slope and walking speed will be adjusted to replicate the intensity and physical demand of the three outdoor routes. The four interventions will be organized to create three different exposure sequences. Each exposure sequence will be randomly assigned to a different group. In turn, each participant will be randomly assigned to one of the three groups, so that all participants will undergo all four interventions in a repeated measures design. Our hypothesis supports the idea that exposure to forest environments causes changes in physiological parameters and mood associated with positive regulation for health and for the autonomic nervous system in healthy adults compared to a neutral non-forest environment. As a second hypothesis, environmental characteristics as well as the perceived quality of the forest environment would be related to the magnitude of such changes associated with autonomic nervous system regulation and mood in healthy adults.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
16

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jul 2025

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

July 27, 2025

Completed
1 day until next milestone

First Submitted

Initial submission to the registry

July 28, 2025

Completed
14 days until next milestone

First Posted

Study publicly available on registry

August 11, 2025

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 22, 2025

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

October 30, 2025

Completed
Last Updated

April 23, 2026

Status Verified

April 1, 2026

Enrollment Period

2 months

First QC Date

July 28, 2025

Last Update Submit

April 18, 2026

Conditions

Keywords

Forest therapyAutonomic nervous systemMoodforest

Outcome Measures

Primary Outcomes (12)

  • CHANGES IN RR INTERVAL DURING FOREST EXPOSURE

    We will measure this variable continuously from 5 minutes before the start of each walk to 5 minutes after the end of each walk. The RR interval is a parameter related to Heart Rate Variability, its analysis is commonly used to evaluate the functioning of cardiac autonomic regulation.

    This measurement is carried out each of the four days in which the subjects take a walk in each of the four study places. From 5 minutes before the start of the 3 km walk until 5 minutes after the end of the walk.

  • CHANGES IN Root Mean Square of Successive Difference Root of RR Interval (RMSSD) DURING FOREST EXPOSURE

    We will measure this variable continuously from 5 minutes before the start of each walk to 5 minutes after the end of each walk. The RMSSD is a parameter related to Heart Rate Variability, its analysis is commonly used to evaluate the functioning of cardiac autonomic regulation.

    This measurement is carried out each of the four days in which the subjects take a walk in each of the four study places. From 5 minutes before the start of the 3 km walk until 5 minutes after the end of the walk.

  • CHANGES IN standard deviation of RR intervals (SDNN) DURING FOREST EXPOSURE

    We will measure this variable continuously from 5 minutes before the start of each walk to 5 minutes after the end of each walk. The SDNN is a parameter related to Heart Rate Variability, its analysis is commonly used to evaluate the functioning of cardiac autonomic regulation.

    This measurement is carried out each of the four days in which the subjects take a walk in each of the four study places. From 5 minutes before the start of the 3 km walk until 5 minutes after the end of the walk.

  • CHANGES IN High frequency component (HF) DURING FOREST EXPOSURE

    We will measure this variable continuously from 5 minutes before the start of each walk to 5 minutes after the end of each walk. The HF component is a parameter related to Heart Rate Variability, its analysis is commonly used to evaluate the functioning of cardiac autonomic regulation.

    This measurement is carried out each of the four days in which the subjects take a walk in each of the four study places. From 5 minutes before the start of the 3 km walk until 5 minutes after the end of the walk.

  • CHANGES IN Low frequency component (LF) DURING FOREST EXPOSURE

    We will measure this variable continuously from 5 minutes before the start of each walk to 5 minutes after the end of each walk. The LF component is a parameter related to Heart Rate Variability, its analysis is commonly used to evaluate the functioning of cardiac autonomic regulation.

    This measurement is carried out each of the four days in which the subjects take a walk in each of the four study places. From 5 minutes before the start of the 3 km walk until 5 minutes after the end of the walk.

  • CHANGES IN Sympathovagal balance (LF/HF) DURING FOREST EXPOSURE

    We will measure this variable continuously from 5 minutes before the start of each walk to 5 minutes after the end of each walk. The sympathovagal balance is a parameter related to Heart Rate Variability, its analysis is commonly used to evaluate the functioning of cardiac autonomic regulation.

    This measurement is carried out each of the four days in which the subjects take a walk in each of the four study places. From 5 minutes before the start of the 3 km walk until 5 minutes after the end of the walk.

  • CHANGES IN HEART RATE

    We will measure this variable punctually on four occasions each of the 4 days of intervention. This data will be taken with an Automated Blood Pressure Device placed on the left arm with participants resting in a seated position. Each measurement is taken three times. Participants rest for 5 minutes before the measurements.

    This measurement is carried out each of the four days in which the subjects take a walk in each of the four study places: Baseline (min 0), 5 minutes pre walk, 5 minutes post walk and after the period of time corresponding to the vehicle journey.

  • CHANGES IN SYSTOLIC BLOOD PRESSURE

    We will measure this variable punctually on four occasions each of the 4 days of intervention. This data will be taken with an Automated Blood Pressure Device placed on the left arm with participants resting in a seated position. Each measurement is taken three times. Participants rest for 5 minutes before the measurements.

    This measurement is carried out each of the four days in which the subjects take a walk in each of the four study places: Baseline (min 0), 5 minutes pre walk, 5 minutes post walk and after the period of time corresponding to the vehicle journey.

  • CHANGES IN DIASTOLIC BLOOD PRESSURE

    We will measure this variable punctually on four occasions each of the 4 days of intervention. This data will be taken with an Automated Blood Pressure Device placed on the left arm with participants resting in a seated position. Each measurement is taken three times. Participants rest for 5 minutes before the measurements.

    This measurement is carried out each of the four days in which the subjects take a walk in each of the four study places: Baseline (min 0), 5 minutes pre walk, 5 minutes post walk and after the period of time corresponding to the vehicle journey.

  • CHANGES IN THE PROFILE OF MOOD STATES. SHORT SPANISH VERSION

    We will measure this variable punctually on two occasions each of the 4 days of intervention. The POMS is a questionnaire for the measurement of mood. POMS is a reliable and valid psychometric instrument that includes 30 adjectives in this Spanish short versions, rated on a scale of 0-4 (0 = none; 4 = very strong), which can be integrated into six factors, four of these factors are negative: Anger, Fatigue, Tension and Depressed State; and two are positive: Vigour and Friendship.

    This measurement is carried out each of the four days in which the subjects take a walk in each of the four study places: Baseline (min 0) and post walk immediately after finishing physiological measurements

  • CHANGES IN TOTAL MOOD DISTURBANCE

    We will measure this variable punctually on two occasions each of the 4 days of intervention. Total Mood Disturbance TMD It is a score that measures a person's emotional distress, psychological distress or subjective well-being. It can be obtained from POMS results; it is calculated from the sum of all the values obtained for each factor, with the exception of the two positive factors, which are subtracted.

    This measurement is carried out each of the four days in which the subjects take a walk in each of the four study places: Baseline (min 0) and post walk immediately after finishing physiological measurements

  • SCALE OF PERCEIVED ENVIRONMENTAL QUALITY OF THE FOREST ENVIRONMENT

    We will measure this variable once each of the 4 days of intervention. We will use the "Scale of perceived environmental quality of the forest environment", a 41-question recording method to determine the quality perceived by the respondent of a given forest environment. It is configured by means of a series of questions in which the person quantitatively rates certain characteristics of the tree stands according to his or her own criteria. 39 of the questions use a 5-point Likert scale in which each question is rated from 1 to 5, with 1 = Not at all, and 5 = Very much. Questions 40 and 41 are called criterion questions where on a scale of 1 to 10 the person responds according to his or her criteria 1 = very low/very little and 10 = outstanding.

    This measurement is performed on each of the three days when subjects take a walk in each of the three outdoor study environments: Post walk, immediately after completing the physiological measurements.

Study Arms (3)

EXPOSURE IN SEQUENCE OF A-B-C-D ENVIRONMENTS

EXPERIMENTAL
Other: WALK THROUGH ENVIRONMENT AOther: WALK THROUGH ENVIRONMENT BOther: WALK THROUGH ENVIRONMENT COther: WALK THROUGH ENVIRONMENT D

EXPOSURE IN SEQUENCE OF B-C-A-D ENVIRONMENTS

EXPERIMENTAL
Other: WALK THROUGH ENVIRONMENT AOther: WALK THROUGH ENVIRONMENT BOther: WALK THROUGH ENVIRONMENT COther: WALK THROUGH ENVIRONMENT D

EXPOSURE IN SEQUENCE OF C-A-B-D ENVIRONMENTS

EXPERIMENTAL
Other: WALK THROUGH ENVIRONMENT AOther: WALK THROUGH ENVIRONMENT BOther: WALK THROUGH ENVIRONMENT COther: WALK THROUGH ENVIRONMENT D

Interventions

A 3 km solo hike at a leisurely walking pace on a path that is easy to walk and has very little elevation gain. Located in Pontevedra Province.

EXPOSURE IN SEQUENCE OF A-B-C-D ENVIRONMENTSEXPOSURE IN SEQUENCE OF B-C-A-D ENVIRONMENTSEXPOSURE IN SEQUENCE OF C-A-B-D ENVIRONMENTS

A 3 km solo hike at a leisurely pace on an easy walking trail with very little elevation gain. Located in the province of Pontevedra.

EXPOSURE IN SEQUENCE OF A-B-C-D ENVIRONMENTSEXPOSURE IN SEQUENCE OF B-C-A-D ENVIRONMENTSEXPOSURE IN SEQUENCE OF C-A-B-D ENVIRONMENTS

3 km solo hike at a leisurely pace on an easy trail with little elevation gain. Located in the province of Pontevedra.

EXPOSURE IN SEQUENCE OF A-B-C-D ENVIRONMENTSEXPOSURE IN SEQUENCE OF B-C-A-D ENVIRONMENTSEXPOSURE IN SEQUENCE OF C-A-B-D ENVIRONMENTS

Individual 3 km treadmill walk in a closed room facing a wall without pictures or windows at a leisurely walking pace with no gradient. This room will be located on the Pontevedra University Campus.

EXPOSURE IN SEQUENCE OF A-B-C-D ENVIRONMENTSEXPOSURE IN SEQUENCE OF B-C-A-D ENVIRONMENTSEXPOSURE IN SEQUENCE OF C-A-B-D ENVIRONMENTS

Eligibility Criteria

Age50 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • \- Those who have the ability and physical strength to walk 3 km in a calm manner without presenting or consciously suffering any type of adverse symptom.

You may not qualify if:

  • Pregnancy
  • History of severe physical or mental illness
  • Drug addiction (including narcotic drugs and non-narcotics) habitual.
  • High risk of fall
  • Severe outdoor allergies

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Universidad de Vigo. Campus Pontevedra

Pontevedra, Pontevedra, 36005, Spain

Location

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
CARE PROVIDER
Masking Details
The persons in charge of the measurements will also be masked before the transfer of the subjects and after the return of the subjects to the place of departure on the days of exposure; they will not know which exposure each subject will perform on each day of intervention.
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal investigator

Study Record Dates

First Submitted

July 28, 2025

First Posted

August 11, 2025

Study Start

July 27, 2025

Primary Completion

September 22, 2025

Study Completion

October 30, 2025

Last Updated

April 23, 2026

Record last verified: 2026-04

Locations