Immune Response and Affective States of Elderly and 50+ Individuals After Intentional and Indirect Contact With Nature

NCT05492006 | Completed DMC

• 1 other identifier: e-Nature NK
• Study Type: interventional
• Target: 54
• Locations: 1 country
• Sites: 1

Brief Summary

Randomized clinical trial on the influence of intentional and indirect contact with nature on the immune response and affective states in people aged 50 years or older.

Conditions

Elderly

Keywords

health promotion; healthy aging; nature; immunological; older

Outcome Measures

Primary Outcomes (3)

• Change from Baseline Concentration of Cytokines in Soluble Immune Profile at 30 minutes post intervention, within 48 hours post intervention and within 4 weeks post intervention.

  Quantify the change from baseline pre intervention in concentration of cytokines in plasma pg/ml (GM-CSF, IFNγ, IL-1β, IL-2, IL-4, IL-5, IL-6, IL-7, IL-8, IL-10, IL-12 (p70), IL-3, IL-17A, IL-21, IL-23, ITAC, MIP-1α, MIP 1β, MIP -3 and TNF-α) in comparison the concentrations between the periods of 30 minutes post intervention, within 48 hours post intervention and within 4 weeks post intervention

  immediately pre intervention, 30 minutes post intervention, within 48 hours post intervention and within 4 weeks post intervention

• Change from baseline percentage and absolute number levels of Cellular Immune Profile at 30 minutes post intervention, within 48 hours post intervention and within 4 weeks post intervention

  Quantify the changes from baseline pre intervention of frequencies in percentage of cells and absolute number in the blood of the subpopulation of lymphocytes and NK and their memory status within the period of 30 minutes post intervention, 48 hours and 4 weeks post intervention

  immediately pre intervention, 30 minutes post intervention, within 48 hours post intervention and within 4 weeks post intervention.

• Change from baseline percentage and absolute number levels of Cellular Immune Profile (others) at 30 minutes post intervention, within 48 hours and within 4 weeks post intervention

  To evaluate changes from baseline pre intervention of frequencies, percentage of cells positive for these biomarkers and intensity of expression in the pointed cells. Inhibiting, activating, effector and lytic molecules during the period of 30 minutes post intervention, within 48 hours and within 4 weeks post intervention.

  immediately pre intervention, 30 minutes post intervention, within 48 hours post intervention and within 4 weeks post intervention.

Secondary Outcomes (1)

• Change from baseline affective states at 30 minutes post intervention, within 48 hours post intervention and within 4 weeks post intervention.

  immediately pre intervention, 30 minutes post intervention, within 48 hours post intervention and within 4 weeks post intervention.

Study Arms (2)

Group A: intentional contact with nature

ACTIVE COMPARATOR

Group A volunteers will take a light walk along the park with green space in a single 1-hour session with an emphasis on sense-directed appreciation guided by research team.

Behavioral: Intentional contact with nature

Group B: indirect contact with nature

ACTIVE COMPARATOR

The members of Group B will watch a video with the images of nature during 4 consecutive 15-minute sessions accompanied by the researcher, totaling 1 hour.

Behavioral: Indirect contact with nature

Interventions

Indirect contact with nature BEHAVIORAL

The participants will watch a video with validated images of nature from e-Nature Positive Emotions Photography Database (e-NatPOEM). Four fifteen-minute sessions will be held on four consecutive days, totaling 1 hour.

Also known as: e-NatPOEM

Group B: indirect contact with nature

Intentional contact with nature BEHAVIORAL

The participants will take a light walk in a park with green spaces guided by research team in a single 1-hour session, with an emphasis on sense-directed appreciation.

Also known as: Forest Bathing

Group A: intentional contact with nature

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• individuals of both sexes
• capable of physical and mental to carry out the proposed activities
• capable of mental to fill in the questionnaires.

You may not qualify if:

• autoimmune diseases
• chronic or acute inflammatory diseases
• disease that affects the response of the immune system
• neuromuscular problems
• oncological diseases and neoplastic
• individuals being treated with immunosuppressive drugs or that affect the immune system
• individuals who are under the influence of alcohol or other substances that interfere with cognitive ability
• those who have had contact intentional relationship with nature in the 30-day period prior to participating in the study

Sponsors & Collaborators

• Hospital Israelita Albert Einstein: lead
• Conselho Nacional de Desenvolvimento Científico e Tecnológico: collaborator
• Paulo de Tarso Ricieri de Lima: collaborator

Study Sites (1)

Hospital Israelita Albert Einstein

São Paulo, São Paulo, 05652000, Brazil

Location

Related Publications (1)

• Dal Fabbro D, Catissi G, Borba G, Lima L, Hingst-Zaher E, Rosa J, Victor E, Bernardes L, Souza T, Leao E. e-Nature Positive Emotions Photography Database (e-NatPOEM): affectively rated nature images promoting positive emotions. Sci Rep. 2021 Jun 3;11(1):11696. doi: 10.1038/s41598-021-91013-9.

  PMID: 34083616 BACKGROUND

MeSH Terms

Interventions

Forest Therapy

Intervention Hierarchy (Ancestors)

Relaxation Therapy; Mind-Body Therapies; Complementary Therapies; Therapeutics

Study Officials

• Eliseth R Leão, PhD

  Hospital Israelita Albert Einstein

  PRINCIPAL INVESTIGATOR

• Roberta M Savieto, MNP

  Hospital Israelita Albert Einstein

  STUDY CHAIR

• Gabriela AG Gouveia, BPT

  Beneficência Portuguesa de São Paulo

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 5, 2022
• First Posted: August 8, 2022
• Study Start: June 20, 2023
• Primary Completion: November 30, 2023
• Study Completion: June 30, 2025
• Last Updated: July 18, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will not share

Locations

BR (1)