Immune Response and Affective States of Elderly and 50+ Individuals After Intentional and Indirect Contact With Nature: a Randomized Controlled Clinical Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 54
- 试验地点
- 2
- 主要终点
- 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
研究概览
简要总结
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.
详细描述
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 48-72 hours and 25-35 days 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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •individuals of both sexes
- •capable of physical and mental to carry out the proposed activities
- •capable of mental to fill in the questionnaires.
排除标准
- •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
研究组 & 干预措施
Group B: indirect contact with nature
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.
干预措施: Indirect contact with nature (Behavioral)
Group A: intentional contact with nature
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.
干预措施: Intentional contact with nature (Behavioral)
结局指标
主要结局
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
时间窗: immediately pre intervention, 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
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.
时间窗: immediately pre intervention, 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
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
时间窗: immediately pre intervention, 30 minutes post intervention, within 48 hours post intervention 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.
Change from Baseline Concentration of Cytokines in Soluble Immune Profile at 30 minutes post intervention, within 48-72 hours post intervention and within 25-35 days post intervention.
时间窗: immediately pre intervention, 30 minutes post intervention, within 48-72 hours post intervention and within 25-35 days post intervention
Quantify the change from baseline pre intervention in concentration of cytokines in plasma ng/ml (IFN-γ, IL-10, Granzyme A, IL-13, Granzyme B, IL-2, IL-4, IL-6, TNF-α e perforina) in comparison the concentrations between the periods of 30 minutes post intervention, within 48-72 hours post intervention and within 25-35 days post intervention
Change from baseline of Cellular Immune Profile at 30 minutes post intervention, within 48-72 hours post intervention and within 25-25 days post intervention
时间窗: immediately pre intervention, 30 minutes post intervention, within 48-72 hours post intervention and within 25-35 days post intervention.
Quantify the changes from baseline pre intervention of frequency of cellular immune populations and their inhibiting, activating, effector and lytic molecules of subpopulation of lymphocytes and NK cells and their memory status in the blood within the period of 30 minutes post intervention, 48-72 hours and 25-35 days post intervention.
次要结局
- 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.)
- Change from baseline affective states at 30 minutes post intervention, within 48-72 hours post intervention and within 25-35 days post intervention.(immediately pre intervention, 30 minutes post intervention, within 48-72 hours post intervention and within 25-35 days post intervention.)