PsoriasisNCT04745429
Non-pharmacological Mitigation of Psoriasis
A study testing breathing exercises, cold exposure and meditation in people with Psoriasis and Stress, run by Medical University of Lodz at 1 site in Poland.
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. Read more about this study
- Who is it for?
- Ages 18 to 45 years
- Conditions the study is for
- Psoriasis, Stress, Inflammation
- What is being tested?
- breathing exercises, cold exposure and meditation
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 38 participants
- Where
- 1 sitePoland
- Study dates
- 19 Feb 2020to 6 Oct 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 45 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Aforementioned Age
- Confirmed diagnosis of plaque psoriasis
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Poland1 site
Medical Univeristy of Lodz, Chair of Clinical Immunology and Rheumatology
Lodz, Łódź Voivodeship, 92-213
About this study
Official title: 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.
Read the 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.
- Conditions
- Psoriasis, Stress, Inflammation, Depression, Pruritus, Sleep Disorder
- Being tested
- breathing exercises, cold exposure and meditation
- Keywords
- meditation, exposure to cold, inflammation, breathing
- Medical subject headings
- Psoriasis, Inflammation, Depression, Pruritus, Sleep Wake Disorders, Respiratory Aspiration
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
breathing exercises, cold exposure and meditationOther
It is a combination of exercises that include breathing exercises, cold exposure and meditation
| Study group | Role | What they receive |
|---|---|---|
| Intervention | Experimental | 19 people suffering from psoriasis were performing excersises for 10 weeks Receives: Other: breathing exercises, cold exposure and meditation |
| Control | No intervention | 19 people suffeing from psoriasis that didn't train the exercises |
What is being measured
The primary outcome is the main question the study is designed to answer.
Psoriasis Area Severity Index
Visual assessment of the skin condition. Extreme values: 0-72. The lower the score, the better
Measured: 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.
Measured: 10 weeks
Pruritus Questionnaire
Intensity of pruritus measured with a questionnaire. Extreme values 0-18. The lower the score, the better.
Measured: 10 weeks
Ointment treatment
Change in ointment treatment - consultation result
Measured: 10 weeks
high sensitivity C-reactive protein in serum
Levels of C-reactive protein in serum using high sensitivity measurements
Measured: 10 weeks
Interleukin 6 in serum
Level of interleukin 6 in measured serum
Measured: 10 weeks
Interleukin 6 in saliva
Level of interleukin 6 in measured saliva
Measured: 10 weeks
Interleukin 8 in serum
Level of interleukin 8 measured in saliva
Measured: 10 weeks
Interleukin 8 in saliva
Levels of interleukin 8 measured in saliva
Measured: 10 weeks
Interleukin 10 in serum
Levels of interleukin 10 measured in serum
Measured: 10 weeks
Interleukin 10 in saliva
Levels of interleukine 10 measured in saliva
Measured: 10 weeks
Tumor Necrosis Factor alpha in serum
Levels of Tumor Necrosis Factor in serum
Measured: 10 weeks
Tumor Necrosis Factor alpha in saliva
Levels of Tumor Necrosis Factor in saliva
Measured: 10 weeks
Monocyte count
Monocyte count in peripheral blood morphology
Measured: 10 weeks
Lymphocyte count
Lymphocyte count in peripheral blood morphology
Measured: 10 weeks
Platelet count
Platelet count in peripheral blood morphology
Measured: 10 weeks
Neutrophil count
Neutrophil count in peripheral blood morphology
Measured: 10 weeks
Secondary outcomes (9)
Five Facet Mindfulness Questionnaire - total score
Total result of FFMQ. Extreme values: 39 - 195. The higher the score, the better.
Measured: 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
Measured: 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
Measured: 10 weeks
Observation component of the Five Facet Mindfulness Questionnaire
Index regarding objective observation. Extreme values: 8-40. The higher the score, the better
Measured: 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
Measured: 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
Measured: 10 weeks
Perceived Stress Scale - 10
Questionnaire regarding everyday stress. Extreme values 0-40. The lower the score, the better.
Measured: 10 weeks
Patient Health Questionnaire - 9
Questionnaire regarding depressive symptoms. Extreme values 0 - 27. The lower the score, the better
Measured: 10 weeks
Pittsburgh Sleep Quality Index
Questionnaire regarding sleep quality. Extreme values 0 - 21, the lower the score, the better
Measured: 10 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Feb 2021
- Study start19 Feb 2020
- Primary completion30 Apr 2020
- Study completion6 Oct 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PsoriasisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Two groups, intervention and control, 10 weeks of intervention. Study visits, blood, saliva collection twice: "before" and "after".
- Masking
- None (open label)
- Enrolment
- 38 participants (actual)
Sponsor and investigators
- Lead sponsor
- Medical University of Lodz
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jan Czarnecki, Medical University of Lodz
- Investigators
- Anna Zalewska-Janowska, professor, Study director, Psychodermatology Department
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04745429
- Sponsor's protocol ID
- RNN/347/18/KE
- Status last verified
- Sep 2021
- First submitted
- 2 Feb 2021
- Last updated
- 16 Sep 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Sep 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Combination of Breathing Exercises, Cold Exposure, and Meditation Mitigate Psoriasis - Open Label, Randomized, Controlled Trial
- ClinicalTrials.gov ID
- NCT04745429
- Acronym / sponsor ID
- RNN/347/18/KE
- Conditions
- Psoriasis, Stress, Inflammation, Depression, Pruritus, Sleep Disorder
- Keywords
- meditation, exposure to cold, inflammation, breathing
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 38 participants (actual)
- Lead sponsor
- Medical University of LodzUniversity, hospital or other
- Study start
- 19 Feb 2020 (actual)
- Primary completion
- 30 Apr 2020 (actual)
- Study completion
- 6 Oct 2020 (actual)
- First posted
- 9 Feb 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Two groups, intervention and control, 10 weeks of intervention. Study visits, blood, saliva collection twice: "before" and "after".
| Arm | Type | Receives |
|---|---|---|
| Intervention | Experimental | Other: breathing exercises, cold exposure and meditation19 people suffering from psoriasis were performing excersises for 10 weeks |
| Control | No intervention | –19 people suffeing from psoriasis that didn't train the exercises |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Aforementioned Age
- Confirmed diagnosis of plaque psoriasis
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| breathing exercises, cold exposure and meditationIt is a combination of exercises that include breathing exercises, cold exposure and meditation | Other | Intervention |
Primary outcome
Psoriasis Area Severity Index
Time frame: 10 weeks
Visual assessment of the skin condition. Extreme values: 0-72. The lower the score, the better
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.
Pruritus Questionnaire
Time frame: 10 weeks
Intensity of pruritus measured with a questionnaire. Extreme values 0-18. The lower the score, the better.
Ointment treatment
Time frame: 10 weeks
Change in ointment treatment - consultation result
high sensitivity C-reactive protein in serum
Time frame: 10 weeks
Levels of C-reactive protein in serum using high sensitivity measurements
Interleukin 6 in serum
Time frame: 10 weeks
Level of interleukin 6 in measured serum
Interleukin 6 in saliva
Time frame: 10 weeks
Level of interleukin 6 in measured saliva
Interleukin 8 in serum
Time frame: 10 weeks
Level of interleukin 8 measured in saliva
Interleukin 8 in saliva
Time frame: 10 weeks
Levels of interleukin 8 measured in saliva
Interleukin 10 in serum
Time frame: 10 weeks
Levels of interleukin 10 measured in serum
Interleukin 10 in saliva
Time frame: 10 weeks
Levels of interleukine 10 measured in saliva
Tumor Necrosis Factor alpha in serum
Time frame: 10 weeks
Levels of Tumor Necrosis Factor in serum
Tumor Necrosis Factor alpha in saliva
Time frame: 10 weeks
Levels of Tumor Necrosis Factor in saliva
Monocyte count
Time frame: 10 weeks
Monocyte count in peripheral blood morphology
Lymphocyte count
Time frame: 10 weeks
Lymphocyte count in peripheral blood morphology
Platelet count
Time frame: 10 weeks
Platelet count in peripheral blood morphology
Neutrophil count
Time frame: 10 weeks
Neutrophil count in peripheral blood morphology
9 secondary outcomes
Five Facet Mindfulness Questionnaire - total score
Time frame: 10 weeks
Non-Judgement component of the Five Facet Mindfulness Questionnaire
Time frame: 10 weeks
Non-Reactivity component of the Five Facet Mindfulness Questionnaire
Time frame: 10 weeks
Observation component of the Five Facet Mindfulness Questionnaire
Time frame: 10 weeks
Acting with awareness component of the Five Facet Mindfulness Questionnaire
Time frame: 10 weeks
Describing component of the Five Facet Mindfulness Questionnaire
Time frame: 10 weeks
Perceived Stress Scale - 10
Time frame: 10 weeks
Patient Health Questionnaire - 9
Time frame: 10 weeks
Pittsburgh Sleep Quality Index
Time frame: 10 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Sep 2021.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Anna Zalewska-Janowska, professor study director
Psychodermatology Department
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing breathing exercises, cold exposure and meditation in people with Psoriasis and Stress, run by Medical University of Lodz at 1 site in Poland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 16 Sep 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Poland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Psoriasis Area Severity Index (time frame: 10 weeks). The study lists 17 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Sep 2021.