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Non-pharmacological Mitigation of Psoriasis

Combination of Breathing Exercises, Cold Exposure, and Meditation Mitigate Psoriasis - Open Label, Randomized, Controlled Trial

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04745429
Enrollment
38
Registered
2021-02-09
Start date
2020-02-19
Completion date
2020-10-06
Last updated
2021-09-16

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Depression, Inflammation, Pruritus, Psoriasis, Quality of Life, Sleep Disorder, Stress

Keywords

meditation, exposure to cold, inflammation, breathing

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.

Interventions

OTHERbreathing exercises, cold exposure and meditation

It is a combination of exercises that include breathing exercises, cold exposure and meditation

Sponsors

Medical University of Lodz
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Masking description

It is impossible to conduct a masked trial as the intervention is collection of exercises that have to be taught by an instructor.

Intervention model description

Two groups, intervention and control, 10 weeks of intervention. Study visits, blood, saliva collection twice: before and after.

Eligibility

Sex/Gender
ALL
Age
18 Years to 45 Years
Healthy volunteers
No

Inclusion criteria

* Aforementioned Age * Confirmed diagnosis of plaque psoriasis

Exclusion criteria

* 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

Design outcomes

Primary

MeasureTime frameDescription
Neutrophil count10 weeksNeutrophil count in peripheral blood morphology
Interleukin 8 in serum10 weeksLevel of interleukin 8 measured in saliva
Interleukin 8 in saliva10 weeksLevels of interleukin 8 measured in saliva
Interleukin 10 in serum10 weeksLevels of interleukin 10 measured in serum
Interleukin 10 in saliva10 weeksLevels of interleukine 10 measured in saliva
Tumor Necrosis Factor alpha in serum10 weeksLevels of Tumor Necrosis Factor in serum
Tumor Necrosis Factor alpha in saliva10 weeksLevels of Tumor Necrosis Factor in saliva
Monocyte count10 weeksMonocyte count in peripheral blood morphology
Lymphocyte count10 weeksLymphocyte count in peripheral blood morphology
Platelet count10 weeksPlatelet count in peripheral blood morphology
Psoriasis Area Severity Index10 weeksVisual assessment of the skin condition. Extreme values: 0-72. The lower the score, the better
Dermatology Life Quality Index10 weeksQuestionnaire regarding the influence of the disease on everyday functioning. Extreme values: 0-30. The lower the value, the better.
Pruritus Questionnaire10 weeksIntensity of pruritus measured with a questionnaire. Extreme values 0-18. The lower the score, the better.
Ointment treatment10 weeksChange in ointment treatment - consultation result
high sensitivity C-reactive protein in serum10 weeksLevels of C-reactive protein in serum using high sensitivity measurements
Interleukin 6 in serum10 weeksLevel of interleukin 6 in measured serum
Interleukin 6 in saliva10 weeksLevel of interleukin 6 in measured saliva

Secondary

MeasureTime frameDescription
Non-Judgement component of the Five Facet Mindfulness Questionnaire10 weeksIndex regarding skill of restraining from labeling. Extreme values: 8-40. The higher the score, the better
Non-Reactivity component of the Five Facet Mindfulness Questionnaire10 weeksIndex measuring skill of restraining from uncontrolled reactions. Extreme values: 7-35. The higher the score, the better
Observation component of the Five Facet Mindfulness Questionnaire10 weeksIndex regarding objective observation. Extreme values: 8-40. The higher the score, the better
Acting with awareness component of the Five Facet Mindfulness Questionnaire10 weeksIndex regarding everyday awareness. Extreme values: 8-40. The higher the score, the better
Describing component of the Five Facet Mindfulness Questionnaire10 weeksIndex regarding skill of objective describing. Extreme values: 8-40. The higher the score, the better
Perceived Stress Scale - 1010 weeksQuestionnaire regarding everyday stress. Extreme values 0-40. The lower the score, the better.
Patient Health Questionnaire - 910 weeksQuestionnaire regarding depressive symptoms. Extreme values 0 - 27. The lower the score, the better
Pittsburgh Sleep Quality Index10 weeksQuestionnaire regarding sleep quality. Extreme values 0 - 21, the lower the score, the better
Five Facet Mindfulness Questionnaire - total score10 weeksTotal result of FFMQ. Extreme values: 39 - 195. The higher the score, the better.

Countries

Poland

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026