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Non-pharmacological Mitigation of Psoriasis

M

Medical University of Lodz

Status

Completed

Conditions

Psoriasis
Inflammation
Quality of Life
Sleep Disorder
Depression
Pruritus
Stress

Treatments

Other: breathing exercises, cold exposure and meditation

Study type

Interventional

Funder types

Other

Identifiers

NCT04745429
RNN/347/18/KE

Details and patient eligibility

About

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.

Full 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.

Enrollment

38 patients

Sex

All

Ages

18 to 45 years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

38 participants in 2 patient groups

Intervention
Experimental group
Description:
19 people suffering from psoriasis were performing excersises for 10 weeks
Treatment:
Other: breathing exercises, cold exposure and meditation
Control
No Intervention group
Description:
19 people suffeing from psoriasis that didn't train the exercises

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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