Combination of Breathing Exercises, Cold Exposure, and Meditation Mitigate Psoriasis - Open Label, Randomized, Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 38
- 试验地点
- 2
- 主要终点
- Pruritus Questionnaire
研究概览
简要总结
In the past few years, research has provided evidence for a possibility of dampening immune system by one's will after undergoing a specific training program. Aim of this study was to verity the efficacy in affecting both mind and body by assessing psoriasis activity and psychological functioning. Among the members of both of the groups intensity of skin lesions and pruritus were assessed, consultation regarding treatment took place and multiple questionnaires regarding sleep quality, mindfulness and depressive symptoms were distributed. Blood samples were collected to asses intensity of inflammation, including interleukins.
详细描述
Psoriasis is a skin disease of an unknown origin. Current understanding of its pathophysiology focuses on an undefined imbalance between the immune system and the nervous system. In this study the researchers assessed the effects of a training program which was proven to affect both. A group of psoriatic patients volunteered, and were randomized to either the intervention (n = 19), or control group (n = 19). Subjects in the intervention group were trained for 10 weeks in breathing techniques, exposure to cold and meditation. The control group was not trained.
After two weeks of the intervention, a full lockdown due to the COVID-19 pandemics was introduced. Modified protocol included exercises possible to conduct at home only.
Two study visits (before and after the intervention) took place.
Total count of variables analysed equaled 60. Primary endpoints regarded intensity of psoriasis. This group included laboratory markers (hsCRP, WBC, LEU, MONO, IL-6, IL-8, IL-10, IL-17, TNFalpha) measured in serum and saliva, visual skin assessment performed by a health professional using Psoriasis Area Severity Index, consultations regarding treatment, and results of the questionnaires (Dermatological Life Quality Index, pruritus). Secondary endpoints pertained comorbidities of psoriasis. These were also assessed using questionnaires, and included Pittsburgh Sleep Quality Index, Patient Health Questionnaire - 9 (depressive symptoms), Five Facet Mindfulness Questionnaire, Perceived Stress Scale - 10.
The intervention is a specific combination of breathing exercises, meditation and cold exposure. It has been previously proven to have an effect among healthy young males who were able to drop febrile temperatures induced with an intravenously distributed LPS. That phenomena was achieved using previously trained breathing techniques.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
盲法说明
It is impossible to conduct a masked trial as the intervention is collection of exercises that have to be taught by an instructor.
入排标准
- 年龄范围
- 18 Years 至 45 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Aforementioned Age
- •Confirmed diagnosis of plaque psoriasis
排除标准
- •ultraviolet therapy 2 months prior or introduced later during intervention period
- •lifestyle changes defined as changing jobs, introducing a new diet, or sport, or changing their place of residence
- •kidney disease
- •heart disease
- •active infection
- •pregnancy
- •breastfeeding
结局指标
主要结局
Pruritus Questionnaire
时间窗: 10 weeks
Intensity of pruritus measured with a questionnaire. Extreme values 0-18. The lower the score, the better.
Psoriasis Area Severity Index
时间窗: 10 weeks
Visual assessment of the skin condition. Extreme values: 0-72. The lower the score, the better
Ointment treatment
时间窗: 10 weeks
Change in ointment treatment - consultation result
high sensitivity C-reactive protein in serum
时间窗: 10 weeks
Levels of C-reactive protein in serum using high sensitivity measurements
Interleukin 6 in serum
时间窗: 10 weeks
Level of interleukin 6 in measured serum
Interleukin 10 in saliva
时间窗: 10 weeks
Levels of interleukine 10 measured in saliva
Lymphocyte count
时间窗: 10 weeks
Lymphocyte count in peripheral blood morphology
Platelet count
时间窗: 10 weeks
Platelet count in peripheral blood morphology
Interleukin 8 in saliva
时间窗: 10 weeks
Levels of interleukin 8 measured in saliva
Dermatology Life Quality Index
时间窗: 10 weeks
Questionnaire regarding the influence of the disease on everyday functioning. Extreme values: 0-30. The lower the value, the better.
Interleukin 8 in serum
时间窗: 10 weeks
Level of interleukin 8 measured in saliva
Interleukin 10 in serum
时间窗: 10 weeks
Levels of interleukin 10 measured in serum
Tumor Necrosis Factor alpha in serum
时间窗: 10 weeks
Levels of Tumor Necrosis Factor in serum
Tumor Necrosis Factor alpha in saliva
时间窗: 10 weeks
Levels of Tumor Necrosis Factor in saliva
Monocyte count
时间窗: 10 weeks
Monocyte count in peripheral blood morphology
Interleukin 6 in saliva
时间窗: 10 weeks
Level of interleukin 6 in measured saliva
Neutrophil count
时间窗: 10 weeks
Neutrophil count in peripheral blood morphology
次要结局
- Pittsburgh Sleep Quality Index(10 weeks)
- Observation component of the Five Facet Mindfulness Questionnaire(10 weeks)
- Non-Judgement component of the Five Facet Mindfulness Questionnaire(10 weeks)
- Describing component of the Five Facet Mindfulness Questionnaire(10 weeks)
- Five Facet Mindfulness Questionnaire - total score(10 weeks)
- Non-Reactivity component of the Five Facet Mindfulness Questionnaire(10 weeks)
- Perceived Stress Scale - 10(10 weeks)
- Patient Health Questionnaire - 9(10 weeks)
- Acting with awareness component of the Five Facet Mindfulness Questionnaire(10 weeks)
研究者
Jan Czarnecki
Principal Investigator
Medical University of Lodz