Non-pharmacological Mitigation of Psoriasis

Sponsor
Medical University of Lodz (Other)
Overall Status
Completed
CT.gov ID
NCT04745429
Collaborator
(none)
38
Enrollment
1
Location
2
Arms
7.6
Actual Duration (Months)
5
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or DiseaseIntervention/TreatmentPhase
  • Other: breathing exercises, cold exposure and meditation
N/A

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 Design

Study Type:
Interventional
Actual Enrollment :
38 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Intervention Model Description:
Two groups, intervention and control, 10 weeks of intervention. Study visits, blood, saliva collection twice: "before" and "after".Two groups, intervention and control, 10 weeks of intervention. Study visits, blood, saliva collection twice: "before" and "after".
Masking:
None (Open Label)
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.
Primary Purpose:
Treatment
Official Title:
Combination of Breathing Exercises, Cold Exposure, and Meditation Mitigate Psoriasis - Open Label, Randomized, Controlled Trial
Actual Study Start Date :
Feb 19, 2020
Actual Primary Completion Date :
Apr 30, 2020
Actual Study Completion Date :
Oct 6, 2020

Arms and Interventions

ArmIntervention/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

Outcome Measures

Primary Outcome Measures

  1. Psoriasis Area Severity Index [10 weeks]

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

  2. 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.

  3. Pruritus Questionnaire [10 weeks]

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

  4. Ointment treatment [10 weeks]

    Change in ointment treatment - consultation result

  5. high sensitivity C-reactive protein in serum [10 weeks]

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

  6. Interleukin 6 in serum [10 weeks]

    Level of interleukin 6 in measured serum

  7. Interleukin 6 in saliva [10 weeks]

    Level of interleukin 6 in measured saliva

  8. Interleukin 8 in serum [10 weeks]

    Level of interleukin 8 measured in saliva

  9. Interleukin 8 in saliva [10 weeks]

    Levels of interleukin 8 measured in saliva

  10. Interleukin 10 in serum [10 weeks]

    Levels of interleukin 10 measured in serum

  11. Interleukin 10 in saliva [10 weeks]

    Levels of interleukine 10 measured in saliva

  12. Tumor Necrosis Factor alpha in serum [10 weeks]

    Levels of Tumor Necrosis Factor in serum

  13. Tumor Necrosis Factor alpha in saliva [10 weeks]

    Levels of Tumor Necrosis Factor in saliva

  14. Monocyte count [10 weeks]

    Monocyte count in peripheral blood morphology

  15. Lymphocyte count [10 weeks]

    Lymphocyte count in peripheral blood morphology

  16. Platelet count [10 weeks]

    Platelet count in peripheral blood morphology

  17. Neutrophil count [10 weeks]

    Neutrophil count in peripheral blood morphology

Secondary Outcome Measures

  1. Five Facet Mindfulness Questionnaire - total score [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 [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 [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 [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 [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 [10 weeks]

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

  7. Perceived Stress Scale - 10 [10 weeks]

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

  8. Patient Health Questionnaire - 9 [10 weeks]

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

  9. Pittsburgh Sleep Quality Index [10 weeks]

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

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 45 Years
Sexes Eligible for Study:
All
Accepts 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

Contacts and Locations

Locations

SiteCityStateCountryPostal Code
1Medical Univeristy of Lodz, Chair of Clinical Immunology and RheumatologyŁódźŁódzkiePoland92-213

Sponsors and Collaborators

  • Medical University of Lodz

Investigators

  • Study Director: Anna Zalewska-Janowska, professor, Psychodermatology Department

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Jan Czarnecki, Principal Investigator, Medical University of Lodz
ClinicalTrials.gov Identifier:
NCT04745429
Other Study ID Numbers:
  • RNN/347/18/KE
First Posted:
Feb 9, 2021
Last Update Posted:
Sep 16, 2021
Last Verified:
Sep 1, 2021
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Jan Czarnecki, Principal Investigator, Medical University of Lodz
Additional relevant MeSH terms:

Study Results

No Results Posted as of Sep 16, 2021