Clinical trial NCT05492006: Immune Response and Affective States of Elderly and 50+ Individuals After Intentional and Indirect Contact with Nature
Official title: Immune Response and Affective States of Elderly and 50+ Individuals After Intentional and Indirect Contact with Nature: a Randomized Controlled Clinical Trial
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Elderly
Keywords: health promotion
healthy aging
nature
immunological
older
Lead sponsor: Hospital Israelita Albert Einstein
Sponsor class: OTHER
Collaborators: name: Conselho Nacional de Desenvolvimento Científico e Tecnológico
name: Paulo de Tarso Ricieri de Lima
First posted: 2022-08-08
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

Detailed 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.

Eligibility criteria: 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

Primary outcomes:
measure: 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.
timeFrame: immediately pre intervention, 30 minutes post intervention, within 48 hours post intervention and within 4 weeks post intervention
measure: 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
timeFrame: immediately pre intervention, 30 minutes post intervention, within 48 hours post intervention and within 4 weeks post intervention.
measure: 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
timeFrame: immediately pre intervention, 30 minutes post intervention, within 48 hours post intervention and within 4 weeks post intervention.
Secondary outcomes:
measure: Change from baseline affective states at 30 minutes post intervention, within 48 hours post intervention and within 4 weeks post intervention.
timeFrame: immediately pre intervention, 30 minutes post intervention, within 48 hours post intervention and within 4 weeks post intervention.
Other outcomes:
Locations:
city: São Paulo
country: Brazil
facility: Hospital Israelita Albert Einstein
Study officials:
affiliation: Hospital Israelita Albert Einstein
name: Eliseth R Leão, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Hospital Israelita Albert Einstein
name: Roberta M Savieto, MNP
role: STUDY_CHAIR
affiliation: Beneficência Portuguesa de São Paulo
name: Gabriela AG Gouveia, BPT
role: STUDY_CHAIR
References:
citation: 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.