Non-pharmacological Mitigation of Psoriasis

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

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.

Study Overview

• Status: Completed
• Conditions: Depression; Quality of Life; Inflammation; Sleep Disorder; Stress; Psoriasis; Pruritus
• Intervention / Treatment: Other: breathing exercises, cold exposure and meditation

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.

• Study Type: Interventional
• Enrollment (Actual): 38
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Poland
  • Łódzkie
    • Łódź, Łódzkie, Poland, 92-213
      • Medical Univeristy of Lodz, Chair of Clinical Immunology and Rheumatology

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years to 43 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Intervention; 19 people suffering from psoriasis were performing excersises for 10 weeks	Other: breathing exercises, cold exposure and meditation; It is a combination of exercises that include breathing exercises, cold exposure and meditation
No Intervention: Control; 19 people suffeing from psoriasis that didn't train the exercises

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Psoriasis Area Severity Index	Visual assessment of the skin condition. Extreme values: 0-72. The lower the score, the better	10 weeks
Dermatology Life Quality Index	Questionnaire regarding the influence of the disease on everyday functioning. Extreme values: 0-30. The lower the value, the better.	10 weeks
Pruritus Questionnaire	Intensity of pruritus measured with a questionnaire. Extreme values 0-18. The lower the score, the better.	10 weeks
Ointment treatment	Change in ointment treatment - consultation result	10 weeks
high sensitivity C-reactive protein in serum	Levels of C-reactive protein in serum using high sensitivity measurements	10 weeks
Interleukin 6 in serum	Level of interleukin 6 in measured serum	10 weeks
Interleukin 6 in saliva	Level of interleukin 6 in measured saliva	10 weeks
Interleukin 8 in serum	Level of interleukin 8 measured in saliva	10 weeks
Interleukin 8 in saliva	Levels of interleukin 8 measured in saliva	10 weeks
Interleukin 10 in serum	Levels of interleukin 10 measured in serum	10 weeks
Interleukin 10 in saliva	Levels of interleukine 10 measured in saliva	10 weeks
Tumor Necrosis Factor alpha in serum	Levels of Tumor Necrosis Factor in serum	10 weeks
Tumor Necrosis Factor alpha in saliva	Levels of Tumor Necrosis Factor in saliva	10 weeks
Monocyte count	Monocyte count in peripheral blood morphology	10 weeks
Lymphocyte count	Lymphocyte count in peripheral blood morphology	10 weeks
Platelet count	Platelet count in peripheral blood morphology	10 weeks
Neutrophil count	Neutrophil count in peripheral blood morphology	10 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Five Facet Mindfulness Questionnaire - total score	Total result of FFMQ. Extreme values: 39 - 195. The higher the score, the better.	10 weeks
Non-Judgement component of the Five Facet Mindfulness Questionnaire	Index regarding skill of restraining from labeling. Extreme values: 8-40. The higher the score, the better	10 weeks
Non-Reactivity component of the Five Facet Mindfulness Questionnaire	Index measuring skill of restraining from uncontrolled reactions. Extreme values: 7-35. The higher the score, the better	10 weeks
Observation component of the Five Facet Mindfulness Questionnaire	Index regarding objective observation. Extreme values: 8-40. The higher the score, the better	10 weeks
Acting with awareness component of the Five Facet Mindfulness Questionnaire	Index regarding everyday awareness. Extreme values: 8-40. The higher the score, the better	10 weeks
Describing component of the Five Facet Mindfulness Questionnaire	Index regarding skill of objective describing. Extreme values: 8-40. The higher the score, the better	10 weeks
Perceived Stress Scale - 10	Questionnaire regarding everyday stress. Extreme values 0-40. The lower the score, the better.	10 weeks
Patient Health Questionnaire - 9	Questionnaire regarding depressive symptoms. Extreme values 0 - 27. The lower the score, the better	10 weeks
Pittsburgh Sleep Quality Index	Questionnaire regarding sleep quality. Extreme values 0 - 21, the lower the score, the better	10 weeks

Collaborators and Investigators

• Sponsor: Medical University of Lodz
• Investigators: Study Director: Anna Zalewska-Janowska, professor, Psychodermatology Department

Study record dates

Study Major Dates

• Study Start (Actual): February 19, 2020
• Primary Completion (Actual): April 30, 2020
• Study Completion (Actual): October 6, 2020

Study Registration Dates

• First Submitted: February 2, 2021
• First Submitted That Met QC Criteria: February 8, 2021
• First Posted (Actual): February 9, 2021

Study Record Updates

• Last Update Posted (Actual): September 16, 2021
• Last Update Submitted That Met QC Criteria: September 9, 2021
• Last Verified: September 1, 2021

More Information

Terms related to this study

• Keywords: breathing; meditation; inflammation; exposure to cold
• Additional Relevant MeSH Terms: Mental Disorders; Pathologic Processes; Nervous System Diseases; Skin Diseases; Neurologic Manifestations; Skin Diseases, Papulosquamous; Skin Manifestations; Inflammation; Sleep Wake Disorders; Psoriasis; Pruritus
• Other Study ID Numbers: RNN/347/18/KE

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No