Skip to main content
OpenTrials
Completed

NCT Number: NCT04745429

Non-pharmacological Mitigation of Psoriasis

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.

Completed

Looking for future studies?

Notify Me

Key information

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

breathing exercises, cold exposure and meditation

Other

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

Primary outcomes

  1. Psoriasis Area Severity Index

    Time frame: 10 weeks

    Visual assessment of the skin condition. Extreme values: 0-72. The lower the score, the better

  2. Dermatology Life Quality Index

    Time frame: 10 weeks

    Questionnaire regarding the influence of the disease on everyday functioning. Extreme values: 0-30. The lower the value, the better.

  3. Pruritus Questionnaire

    Time frame: 10 weeks

    Intensity of pruritus measured with a questionnaire. Extreme values 0-18. The lower the score, the better.

  4. Ointment treatment

    Time frame: 10 weeks

    Change in ointment treatment - consultation result

  5. high sensitivity C-reactive protein in serum

    Time frame: 10 weeks

    Levels of C-reactive protein in serum using high sensitivity measurements

  6. Interleukin 6 in serum

    Time frame: 10 weeks

    Level of interleukin 6 in measured serum

  7. Interleukin 6 in saliva

    Time frame: 10 weeks

    Level of interleukin 6 in measured saliva

  8. Interleukin 8 in serum

    Time frame: 10 weeks

    Level of interleukin 8 measured in saliva

  9. Interleukin 8 in saliva

    Time frame: 10 weeks

    Levels of interleukin 8 measured in saliva

  10. Interleukin 10 in serum

    Time frame: 10 weeks

    Levels of interleukin 10 measured in serum

  11. Interleukin 10 in saliva

    Time frame: 10 weeks

    Levels of interleukine 10 measured in saliva

  12. Tumor Necrosis Factor alpha in serum

    Time frame: 10 weeks

    Levels of Tumor Necrosis Factor in serum

  13. Tumor Necrosis Factor alpha in saliva

    Time frame: 10 weeks

    Levels of Tumor Necrosis Factor in saliva

  14. Monocyte count

    Time frame: 10 weeks

    Monocyte count in peripheral blood morphology

  15. Lymphocyte count

    Time frame: 10 weeks

    Lymphocyte count in peripheral blood morphology

  16. Platelet count

    Time frame: 10 weeks

    Platelet count in peripheral blood morphology

  17. Neutrophil count

    Time frame: 10 weeks

    Neutrophil count in peripheral blood morphology

Secondary outcomes

  1. Five Facet Mindfulness Questionnaire - total score

    Time frame: 10 weeks

    Total result of FFMQ. Extreme values: 39 - 195. The higher the score, the better.

  2. Non-Judgement component of the Five Facet Mindfulness Questionnaire

    Time frame: 10 weeks

    Index regarding skill of restraining from labeling. Extreme values: 8-40. The higher the score, the better

  3. Non-Reactivity component of the Five Facet Mindfulness Questionnaire

    Time frame: 10 weeks

    Index measuring skill of restraining from uncontrolled reactions. Extreme values: 7-35. The higher the score, the better

  4. Observation component of the Five Facet Mindfulness Questionnaire

    Time frame: 10 weeks

    Index regarding objective observation. Extreme values: 8-40. The higher the score, the better

  5. Acting with awareness component of the Five Facet Mindfulness Questionnaire

    Time frame: 10 weeks

    Index regarding everyday awareness. Extreme values: 8-40. The higher the score, the better

  6. Describing component of the Five Facet Mindfulness Questionnaire

    Time frame: 10 weeks

    Index regarding skill of objective describing. Extreme values: 8-40. The higher the score, the better

  7. Perceived Stress Scale - 10

    Time frame: 10 weeks

    Questionnaire regarding everyday stress. Extreme values 0-40. The lower the score, the better.

  8. Patient Health Questionnaire - 9

    Time frame: 10 weeks

    Questionnaire regarding depressive symptoms. Extreme values 0 - 27. The lower the score, the better

  9. Pittsburgh Sleep Quality Index

    Time frame: 10 weeks

    Questionnaire regarding sleep quality. Extreme values 0 - 21, the lower the score, the better

Sponsors and collaborators

Lead sponsor

Medical University of Lodz

Other

Registry information

Official study title

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

Important dates

Study start
2020
Primary completion
2020
Study completion
2020
First posted
Feb 9, 2021
Registry last updated
Sep 16, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.