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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04745429
Other study ID # RNN/347/18/KE
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date February 19, 2020
Est. completion date October 6, 2020

Study information

Verified date September 2021
Source Medical University of Lodz
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 38
Est. completion date October 6, 2020
Est. primary completion date April 30, 2020
Accepts healthy volunteers No
Gender All
Age group 18 Years to 45 Years
Eligibility 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 Design


Intervention

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

Locations

Country Name City State
Poland Medical Univeristy of Lodz, Chair of Clinical Immunology and Rheumatology Lódz Lódzkie

Sponsors (1)

Lead Sponsor Collaborator
Medical University of Lodz

Country where clinical trial is conducted

Poland, 

Outcome

Type Measure Description Time frame Safety issue
Primary Psoriasis Area Severity Index Visual assessment of the skin condition. Extreme values: 0-72. The lower the score, the better 10 weeks
Primary 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
Primary Pruritus Questionnaire Intensity of pruritus measured with a questionnaire. Extreme values 0-18. The lower the score, the better. 10 weeks
Primary Ointment treatment Change in ointment treatment - consultation result 10 weeks
Primary high sensitivity C-reactive protein in serum Levels of C-reactive protein in serum using high sensitivity measurements 10 weeks
Primary Interleukin 6 in serum Level of interleukin 6 in measured serum 10 weeks
Primary Interleukin 6 in saliva Level of interleukin 6 in measured saliva 10 weeks
Primary Interleukin 8 in serum Level of interleukin 8 measured in saliva 10 weeks
Primary Interleukin 8 in saliva Levels of interleukin 8 measured in saliva 10 weeks
Primary Interleukin 10 in serum Levels of interleukin 10 measured in serum 10 weeks
Primary Interleukin 10 in saliva Levels of interleukine 10 measured in saliva 10 weeks
Primary Tumor Necrosis Factor alpha in serum Levels of Tumor Necrosis Factor in serum 10 weeks
Primary Tumor Necrosis Factor alpha in saliva Levels of Tumor Necrosis Factor in saliva 10 weeks
Primary Monocyte count Monocyte count in peripheral blood morphology 10 weeks
Primary Lymphocyte count Lymphocyte count in peripheral blood morphology 10 weeks
Primary Platelet count Platelet count in peripheral blood morphology 10 weeks
Primary Neutrophil count Neutrophil count in peripheral blood morphology 10 weeks
Secondary Five Facet Mindfulness Questionnaire - total score Total result of FFMQ. Extreme values: 39 - 195. The higher the score, the better. 10 weeks
Secondary 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
Secondary 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
Secondary Observation component of the Five Facet Mindfulness Questionnaire Index regarding objective observation. Extreme values: 8-40. The higher the score, the better 10 weeks
Secondary 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
Secondary 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
Secondary Perceived Stress Scale - 10 Questionnaire regarding everyday stress. Extreme values 0-40. The lower the score, the better. 10 weeks
Secondary Patient Health Questionnaire - 9 Questionnaire regarding depressive symptoms. Extreme values 0 - 27. The lower the score, the better 10 weeks
Secondary Pittsburgh Sleep Quality Index Questionnaire regarding sleep quality. Extreme values 0 - 21, the lower the score, the better 10 weeks
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