Clinical trial NCT04745429: Non-pharmacological Mitigation of Psoriasis
Official title: Combination of Breathing Exercises, Cold Exposure, and Meditation Mitigate Psoriasis - Open Label, Randomized, Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Psoriasis
Stress
Inflammation
Depression
Pruritus
Sleep Disorder
Quality of Life
Keywords: meditation
exposure to cold
inflammation
breathing
Lead sponsor: Medical University of Lodz
Sponsor class: OTHER
First posted: 2021-02-09
Enrollment: 38
Sex: ALL
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Two groups, intervention and control, 10 weeks of intervention. Study visits, blood, saliva collection twice: "before" and "after".
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Psoriasis Area Severity Index
timeFrame: 10 weeks
measure: Dermatology Life Quality Index
timeFrame: 10 weeks
measure: Pruritus Questionnaire
timeFrame: 10 weeks
measure: Ointment treatment
timeFrame: 10 weeks
measure: high sensitivity C-reactive protein in serum
timeFrame: 10 weeks
measure: Interleukin 6 in serum
timeFrame: 10 weeks
measure: Interleukin 6 in saliva
timeFrame: 10 weeks
measure: Interleukin 8 in serum
timeFrame: 10 weeks
measure: Interleukin 8 in saliva
timeFrame: 10 weeks
measure: Interleukin 10 in serum
timeFrame: 10 weeks
measure: Interleukin 10 in saliva
timeFrame: 10 weeks
measure: Tumor Necrosis Factor alpha in serum
timeFrame: 10 weeks
measure: Tumor Necrosis Factor alpha in saliva
timeFrame: 10 weeks
measure: Monocyte count
timeFrame: 10 weeks
measure: Lymphocyte count
timeFrame: 10 weeks
measure: Platelet count
timeFrame: 10 weeks
measure: Neutrophil count
timeFrame: 10 weeks
Secondary outcomes:
measure: Five Facet Mindfulness Questionnaire - total score
timeFrame: 10 weeks
measure: Non-Judgement component of the Five Facet Mindfulness Questionnaire
timeFrame: 10 weeks
measure: Non-Reactivity component of the Five Facet Mindfulness Questionnaire
timeFrame: 10 weeks
measure: Observation component of the Five Facet Mindfulness Questionnaire
timeFrame: 10 weeks
measure: Acting with awareness component of the Five Facet Mindfulness Questionnaire
timeFrame: 10 weeks
measure: Describing component of the Five Facet Mindfulness Questionnaire
timeFrame: 10 weeks
measure: Perceived Stress Scale - 10
timeFrame: 10 weeks
measure: Patient Health Questionnaire - 9
timeFrame: 10 weeks
measure: Pittsburgh Sleep Quality Index
timeFrame: 10 weeks
Other outcomes:
Locations:
city: Łódź
country: Poland
facility: Medical Univeristy of Lodz, Chair of Clinical Immunology and Rheumatology
state: Łódzkie
Study officials:
affiliation: Psychodermatology Department
name: Anna Zalewska-Janowska, professor
role: STUDY_DIRECTOR
References: