Non-pharmacological Mitigation of Psoriasis
- Conditions
- Sleep DisorderDepressionQuality of LifePsoriasisStressInflammationPruritus
- Interventions
- Other: breathing exercises, cold exposure and meditation
- Registration Number
- NCT04745429
- Lead Sponsor
- Medical University of Lodz
- Brief Summary
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.
- Detailed Description
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.
For 10 weeks members of the intervention group were trained via popular social media platform. Exercises included exposure to cold using regular, cold showers, performing breathing exercises finished with a short meditation session. Length and general difficulty were gradually built up.
Initially, total number of the subjects equaled 54. 31 for the intervention group and 23 for the control group. Due to drop-out or meeting the exclusion criteria, final count for both of the groups was 19 participants.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 38
- Aforementioned Age
- Confirmed diagnosis of plaque psoriasis
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Intervention breathing exercises, cold exposure and meditation 19 people suffering from psoriasis were performing excersises for 10 weeks
- Primary Outcome Measures
Name Time Method Pruritus Questionnaire 10 weeks Intensity of pruritus measured with a questionnaire. Extreme values 0-18. The lower the score, the better.
Psoriasis Area Severity Index 10 weeks Visual assessment of the skin condition. Extreme values: 0-72. The lower the score, the better
Ointment treatment 10 weeks Change in ointment treatment - consultation result
high sensitivity C-reactive protein in serum 10 weeks Levels of C-reactive protein in serum using high sensitivity measurements
Interleukin 6 in serum 10 weeks Level of interleukin 6 in measured serum
Interleukin 10 in saliva 10 weeks Levels of interleukine 10 measured in saliva
Lymphocyte count 10 weeks Lymphocyte count in peripheral blood morphology
Platelet count 10 weeks Platelet count in peripheral blood morphology
Interleukin 8 in saliva 10 weeks Levels of interleukin 8 measured in saliva
Dermatology Life Quality Index 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 10 weeks Level of interleukin 8 measured in saliva
Interleukin 10 in serum 10 weeks Levels of interleukin 10 measured in serum
Tumor Necrosis Factor alpha in serum 10 weeks Levels of Tumor Necrosis Factor in serum
Tumor Necrosis Factor alpha in saliva 10 weeks Levels of Tumor Necrosis Factor in saliva
Monocyte count 10 weeks Monocyte count in peripheral blood morphology
Interleukin 6 in saliva 10 weeks Level of interleukin 6 in measured saliva
Neutrophil count 10 weeks Neutrophil count in peripheral blood morphology
- Secondary Outcome Measures
Name Time Method Pittsburgh Sleep Quality Index 10 weeks Questionnaire regarding sleep quality. Extreme values 0 - 21, the lower the score, the better
Observation component of the Five Facet Mindfulness Questionnaire 10 weeks Index regarding objective observation. Extreme values: 8-40. The higher the score, the better
Non-Judgement component of the Five Facet Mindfulness Questionnaire 10 weeks Index regarding skill of restraining from labeling. Extreme values: 8-40. The higher the score, the better
Describing component of the Five Facet Mindfulness Questionnaire 10 weeks Index regarding skill of objective describing. Extreme values: 8-40. The higher the score, the better
Five Facet Mindfulness Questionnaire - total score 10 weeks Total result of FFMQ. Extreme values: 39 - 195. The higher the score, the better.
Non-Reactivity component of the Five Facet Mindfulness Questionnaire 10 weeks Index measuring skill of restraining from uncontrolled reactions. Extreme values: 7-35. The higher the score, the better
Perceived Stress Scale - 10 10 weeks Questionnaire regarding everyday stress. Extreme values 0-40. The lower the score, the better.
Patient Health Questionnaire - 9 10 weeks Questionnaire regarding depressive symptoms. Extreme values 0 - 27. The lower the score, the better
Acting with awareness component of the Five Facet Mindfulness Questionnaire 10 weeks Index regarding everyday awareness. Extreme values: 8-40. The higher the score, the better
Trial Locations
- Locations (1)
Medical Univeristy of Lodz, Chair of Clinical Immunology and Rheumatology
🇵🇱Łódź, Łódzkie, Poland