Non-pharmacological Mitigation of Psoriasis

September 9, 2021 updated by: Jan Czarnecki, Medical University of Lodz

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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 Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
38

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Poland
    • Łódzkie
      • Łódź, Łódzkie, Poland, 92-213
        • Medical Univeristy of Lodz, Chair of Clinical Immunology and Rheumatology

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

14 years to 41 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Psoriasis Area Severity Index
Time Frame: 10 weeks
Visual assessment of the skin condition. Extreme values: 0-72. The lower the score, the better
10 weeks
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.
10 weeks
Pruritus Questionnaire
Time Frame: 10 weeks
Intensity of pruritus measured with a questionnaire. Extreme values 0-18. The lower the score, the better.
10 weeks
Ointment treatment
Time Frame: 10 weeks
Change in ointment treatment - consultation result
10 weeks
high sensitivity C-reactive protein in serum
Time Frame: 10 weeks
Levels of C-reactive protein in serum using high sensitivity measurements
10 weeks
Interleukin 6 in serum
Time Frame: 10 weeks
Level of interleukin 6 in measured serum
10 weeks
Interleukin 6 in saliva
Time Frame: 10 weeks
Level of interleukin 6 in measured saliva
10 weeks
Interleukin 8 in serum
Time Frame: 10 weeks
Level of interleukin 8 measured in saliva
10 weeks
Interleukin 8 in saliva
Time Frame: 10 weeks
Levels of interleukin 8 measured in saliva
10 weeks
Interleukin 10 in serum
Time Frame: 10 weeks
Levels of interleukin 10 measured in serum
10 weeks
Interleukin 10 in saliva
Time Frame: 10 weeks
Levels of interleukine 10 measured in saliva
10 weeks
Tumor Necrosis Factor alpha in serum
Time Frame: 10 weeks
Levels of Tumor Necrosis Factor in serum
10 weeks
Tumor Necrosis Factor alpha in saliva
Time Frame: 10 weeks
Levels of Tumor Necrosis Factor in saliva
10 weeks
Monocyte count
Time Frame: 10 weeks
Monocyte count in peripheral blood morphology
10 weeks
Lymphocyte count
Time Frame: 10 weeks
Lymphocyte count in peripheral blood morphology
10 weeks
Platelet count
Time Frame: 10 weeks
Platelet count in peripheral blood morphology
10 weeks
Neutrophil count
Time Frame: 10 weeks
Neutrophil count in peripheral blood morphology
10 weeks

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Five Facet Mindfulness Questionnaire - total score
Time Frame: 10 weeks
Total result of FFMQ. Extreme values: 39 - 195. The higher the score, the better.
10 weeks
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
10 weeks
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
10 weeks
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
10 weeks
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
10 weeks
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
10 weeks
Perceived Stress Scale - 10
Time Frame: 10 weeks
Questionnaire regarding everyday stress. Extreme values 0-40. The lower the score, the better.
10 weeks
Patient Health Questionnaire - 9
Time Frame: 10 weeks
Questionnaire regarding depressive symptoms. Extreme values 0 - 27. The lower the score, the better
10 weeks
Pittsburgh Sleep Quality Index
Time Frame: 10 weeks
Questionnaire regarding sleep quality. Extreme values 0 - 21, the lower the score, the better
10 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Medical University of Lodz

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Director: Anna Zalewska-Janowska, professor, Psychodermatology Department

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
February 19, 2020

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
April 30, 2020

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
October 6, 2020

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
February 2, 2021

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 8, 2021

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
February 9, 2021

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
September 16, 2021

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 9, 2021

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
September 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • RNN/347/18/KE

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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