Non-pharmacological Mitigation of Psoriasis
Primary Purpose
Psoriasis, Stress, Inflammation
Status
Completed
Phase
Not Applicable
Locations
Poland
Study Type
Interventional
Intervention
breathing exercises, cold exposure and meditation
Sponsored by
About this trial
This is an interventional treatment trial for Psoriasis focused on measuring meditation, exposure to cold, inflammation, breathing
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
Sites / Locations
- Medical Univeristy of Lodz, Chair of Clinical Immunology and Rheumatology
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
Intervention
Control
Arm Description
19 people suffering from psoriasis were performing excersises for 10 weeks
19 people suffeing from psoriasis that didn't train the exercises
Outcomes
Primary Outcome Measures
Psoriasis Area Severity Index
Visual assessment of the skin condition. Extreme values: 0-72. The lower the score, the better
Dermatology Life Quality Index
Questionnaire regarding the influence of the disease on everyday functioning. Extreme values: 0-30. The lower the value, the better.
Pruritus Questionnaire
Intensity of pruritus measured with a questionnaire. Extreme values 0-18. The lower the score, the better.
Ointment treatment
Change in ointment treatment - consultation result
high sensitivity C-reactive protein in serum
Levels of C-reactive protein in serum using high sensitivity measurements
Interleukin 6 in serum
Level of interleukin 6 in measured serum
Interleukin 6 in saliva
Level of interleukin 6 in measured saliva
Interleukin 8 in serum
Level of interleukin 8 measured in saliva
Interleukin 8 in saliva
Levels of interleukin 8 measured in saliva
Interleukin 10 in serum
Levels of interleukin 10 measured in serum
Interleukin 10 in saliva
Levels of interleukine 10 measured in saliva
Tumor Necrosis Factor alpha in serum
Levels of Tumor Necrosis Factor in serum
Tumor Necrosis Factor alpha in saliva
Levels of Tumor Necrosis Factor in saliva
Monocyte count
Monocyte count in peripheral blood morphology
Lymphocyte count
Lymphocyte count in peripheral blood morphology
Platelet count
Platelet count in peripheral blood morphology
Neutrophil count
Neutrophil count in peripheral blood morphology
Secondary Outcome Measures
Five Facet Mindfulness Questionnaire - total score
Total result of FFMQ. Extreme values: 39 - 195. The higher the score, the better.
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
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
Observation component of the Five Facet Mindfulness Questionnaire
Index regarding objective observation. Extreme values: 8-40. The higher the score, the better
Acting with awareness component of the Five Facet Mindfulness Questionnaire
Index regarding everyday awareness. Extreme values: 8-40. The higher the score, the better
Describing component of the Five Facet Mindfulness Questionnaire
Index regarding skill of objective describing. Extreme values: 8-40. The higher the score, the better
Perceived Stress Scale - 10
Questionnaire regarding everyday stress. Extreme values 0-40. The lower the score, the better.
Patient Health Questionnaire - 9
Questionnaire regarding depressive symptoms. Extreme values 0 - 27. The lower the score, the better
Pittsburgh Sleep Quality Index
Questionnaire regarding sleep quality. Extreme values 0 - 21, the lower the score, the better
Full Information
NCT ID
NCT04745429
First Posted
February 2, 2021
Last Updated
September 9, 2021
Sponsor
Medical University of Lodz
1. Study Identification
Unique Protocol Identification Number
NCT04745429
Brief Title
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
2. Study Status
Record Verification Date
September 2021
Overall Recruitment Status
Completed
Study Start Date
February 19, 2020 (Actual)
Primary Completion Date
April 30, 2020 (Actual)
Study Completion Date
October 6, 2020 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Medical University of Lodz
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. 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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Psoriasis, Stress, Inflammation, Depression, Pruritus, Sleep Disorder, Quality of Life
Keywords
meditation, exposure to cold, inflammation, breathing
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
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.
Allocation
Randomized
Enrollment
38 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Intervention
Arm Type
Experimental
Arm Description
19 people suffering from psoriasis were performing excersises for 10 weeks
Arm Title
Control
Arm Type
No Intervention
Arm Description
19 people suffeing from psoriasis that didn't train the exercises
Intervention Type
Other
Intervention Name(s)
breathing exercises, cold exposure and meditation
Intervention Description
It is a combination of exercises that include breathing exercises, cold exposure and meditation
Primary Outcome Measure Information:
Title
Psoriasis Area Severity Index
Description
Visual assessment of the skin condition. Extreme values: 0-72. The lower the score, the better
Time Frame
10 weeks
Title
Dermatology Life Quality Index
Description
Questionnaire regarding the influence of the disease on everyday functioning. Extreme values: 0-30. The lower the value, the better.
Time Frame
10 weeks
Title
Pruritus Questionnaire
Description
Intensity of pruritus measured with a questionnaire. Extreme values 0-18. The lower the score, the better.
Time Frame
10 weeks
Title
Ointment treatment
Description
Change in ointment treatment - consultation result
Time Frame
10 weeks
Title
high sensitivity C-reactive protein in serum
Description
Levels of C-reactive protein in serum using high sensitivity measurements
Time Frame
10 weeks
Title
Interleukin 6 in serum
Description
Level of interleukin 6 in measured serum
Time Frame
10 weeks
Title
Interleukin 6 in saliva
Description
Level of interleukin 6 in measured saliva
Time Frame
10 weeks
Title
Interleukin 8 in serum
Description
Level of interleukin 8 measured in saliva
Time Frame
10 weeks
Title
Interleukin 8 in saliva
Description
Levels of interleukin 8 measured in saliva
Time Frame
10 weeks
Title
Interleukin 10 in serum
Description
Levels of interleukin 10 measured in serum
Time Frame
10 weeks
Title
Interleukin 10 in saliva
Description
Levels of interleukine 10 measured in saliva
Time Frame
10 weeks
Title
Tumor Necrosis Factor alpha in serum
Description
Levels of Tumor Necrosis Factor in serum
Time Frame
10 weeks
Title
Tumor Necrosis Factor alpha in saliva
Description
Levels of Tumor Necrosis Factor in saliva
Time Frame
10 weeks
Title
Monocyte count
Description
Monocyte count in peripheral blood morphology
Time Frame
10 weeks
Title
Lymphocyte count
Description
Lymphocyte count in peripheral blood morphology
Time Frame
10 weeks
Title
Platelet count
Description
Platelet count in peripheral blood morphology
Time Frame
10 weeks
Title
Neutrophil count
Description
Neutrophil count in peripheral blood morphology
Time Frame
10 weeks
Secondary Outcome Measure Information:
Title
Five Facet Mindfulness Questionnaire - total score
Description
Total result of FFMQ. Extreme values: 39 - 195. The higher the score, the better.
Time Frame
10 weeks
Title
Non-Judgement component of the Five Facet Mindfulness Questionnaire
Description
Index regarding skill of restraining from labeling. Extreme values: 8-40. The higher the score, the better
Time Frame
10 weeks
Title
Non-Reactivity component of the Five Facet Mindfulness Questionnaire
Description
Index measuring skill of restraining from uncontrolled reactions. Extreme values: 7-35. The higher the score, the better
Time Frame
10 weeks
Title
Observation component of the Five Facet Mindfulness Questionnaire
Description
Index regarding objective observation. Extreme values: 8-40. The higher the score, the better
Time Frame
10 weeks
Title
Acting with awareness component of the Five Facet Mindfulness Questionnaire
Description
Index regarding everyday awareness. Extreme values: 8-40. The higher the score, the better
Time Frame
10 weeks
Title
Describing component of the Five Facet Mindfulness Questionnaire
Description
Index regarding skill of objective describing. Extreme values: 8-40. The higher the score, the better
Time Frame
10 weeks
Title
Perceived Stress Scale - 10
Description
Questionnaire regarding everyday stress. Extreme values 0-40. The lower the score, the better.
Time Frame
10 weeks
Title
Patient Health Questionnaire - 9
Description
Questionnaire regarding depressive symptoms. Extreme values 0 - 27. The lower the score, the better
Time Frame
10 weeks
Title
Pittsburgh Sleep Quality Index
Description
Questionnaire regarding sleep quality. Extreme values 0 - 21, the lower the score, the better
Time Frame
10 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Anna Zalewska-Janowska, professor
Organizational Affiliation
Psychodermatology Department
Official's Role
Study Director
Facility Information:
Facility Name
Medical Univeristy of Lodz, Chair of Clinical Immunology and Rheumatology
City
Łódź
State/Province
Łódzkie
ZIP/Postal Code
92-213
Country
Poland
12. IPD Sharing Statement
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Non-pharmacological Mitigation of Psoriasis
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