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

Elderly Clinical Trial

Official title:

Immune Response and Affective States of Elderly and 50+ Individuals After Intentional and Indirect Contact With Nature: a Randomized Controlled Clinical Trial

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05492006
• Other study ID #: e-Nature NK
• Status: Recruiting
• Phase: N/A
• Start date: June 20, 2023
• Est. completion date: July 2024

Study information

• Verified date: July 2022
• Source: Hospital Israelita Albert Einstein
• Contact: Eliseth R Leão, PhD
• Phone: +5511996186489
• Email: eliseth.leao[@]einstein.br
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Description:

Interaction with nature creates a state of physical relaxation, helping the individual to manage stress and promote health. Along with the ability to reduce stress, nature has been shown to improve immune function in some specific environments. Science already proves that stress conditions affect the immune capacity, generating pathological immune responses and inflammatory responses inappropriate. Therefore, if contact with nature is capable of reducing stress, through this study can find manifestations of improvement of the functions immunological.

This clinical trial aims to analyze intentional (Forest Bathing) and indirect contact (e-NatPOEM) with nature. After informed consent form, participants will be randomized to the study arms. Will be evaluated cells and enzymes of the of the immune system and affective states immediately before the intervention, 30 minutes post intervention, and within 48 hours and four weeks after the intervention. The hypothesis of our study is that both nature-based interventions will stimulate the immune system and will improve affective states. However, intentional direct contact with nature will have superior results than indirect contact.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 60
• Est. completion date: July 2024
• Est. primary completion date: September 30, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• individuals of both sexes

• capable of physical and mental to carry out the proposed activities

• capable of mental to fill in the questionnaires.

Exclusion Criteria:

• 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

Related Conditions & MeSH terms

• Elderly

Intervention

Behavioral:
• Indirect contact with nature
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.
• Intentional contact with nature
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.

Locations

Country	Name	City	State
Brazil	Hospital Israelita Albert Einstein	São Paulo

Sponsors (3)

Lead Sponsor	Collaborator
Hospital Israelita Albert Einstein	Conselho Nacional de Desenvolvimento Científico e Tecnológico, Paulo de Tarso Ricieri de Lima

Country where clinical trial is conducted

Brazil, 

References & 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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, IFN?, IL-1ß, 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-1a, MIP 1ß, MIP -3 and TNF-a) 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
Primary	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.
Primary	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	Change from baseline affective states at 30 minutes post intervention, within 48 hours post intervention and within 4 weeks post intervention.	Will be applied the Profile of Mood States - POMS. It is one of the most used instruments in psychology to assess the states emotions and mood states, as well as the variation associated with them.; Assesses six transient mood states: tension, depression, anger, vigor, fatigue and mental confusion. Each item can be rated on a Likert-type frequency scale of sensations, ranging from 0 (not at all) to 4 (extremely). Scores are not applicable to this scale.	immediately pre intervention, 30 minutes post intervention, within 48 hours post intervention and within 4 weeks post intervention.