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Effect of Qi Gong Training on Quality of Life in Patients With Systemic Lupus Erythematous (LuQi) (LuQi)

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ClinicalTrials.gov Identifier: NCT02732470
Recruitment Status : Completed
First Posted : April 8, 2016
Last Update Posted : November 2, 2018
Sponsor:
Information provided by (Responsible Party):
University Hospital, Limoges

Brief Summary:

Systemic Lupus Erythematosus (SLE) is chronic and systemic autoimmune disease that mainly affecting women and leading to organ damages especially skin, joints, kidneys, central nervous system and heart. In SLE, immune system dysfunction leads to autoantibodies, autoreactive T cells and pro-inflammatory cytokines production. These elements will initiate and maintain organ damages. Patients with SLE have disease flares followed by period of remission. Flares can occur because of stress, infections, surgery, pregnancy or ultraviolet exposition. Furthermore the chronic nature of SLE is an important factor of depression in these patients.

Qi Gong is an ancient Chinese practice based on relaxation movements, posture and breathing in order to harmonize the body and mind. This practice improves the general state by reducing fatigue and improving sleep. The beneficial effect of Qi Gong in medicine has been studied in several diseases including cancer, diabetes, arterial hypertension and fibromyalgia. Qi Gong seems interesting in depressed patients but also to reduce stress in healthy subjects.

The aim of this study is to evaluate the effects of Qi Gong on quality if life in patients with SLE. Patients will have two lessons of 60 minutes per week for three months and a collective lesson of 90 minutes per week for three months. The teacher of Qi-Gong will evaluate adherence to the practice of Qi Gong every week. Clinical and biological data will be collected at baseline and at 2th, 4th, 6th, 9th and 12th month. Different evaluation scores and neurotrophin levels will be collected at baseline and at 6th month.


Condition or disease Intervention/treatment Phase
Lupus Erythematosus, Systemic Other: Qi Gong Not Applicable

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 33 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Effect of Qi Gong Training on Quality of Life in Patients With Systemic Lupus Erythematous (LuQi)
Actual Study Start Date : April 25, 2016
Actual Primary Completion Date : April 10, 2017
Actual Study Completion Date : October 31, 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Lupus

Arm Intervention/treatment
Experimental: Qi Gong
The effect of Qi Gong training on quality of life in patients with systemic lupus erythematosus
Other: Qi Gong
The aim of this study is to evaluate the effects of Qi Gong on quality if life in patients with Systemic Lupus Erythematosus




Primary Outcome Measures :
  1. Differences in quality of life with the SF-36 Physical Function Domain in patients with SLE at baseline and after a six month practice of Qi-Gong [ Time Frame: month 0 - month 6 ]

Secondary Outcome Measures :
  1. Quality of life (SF-36), quality of life in patients with SLE [ Time Frame: months 0, months 2, months 4, months 9 and months 12 ]


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Diagnosis of Systemic Lupus Erythematosus (SLE) according the American Rheumatology Association (ARA) and/or Systemic Lupus International Collaborating Clinics (SLICC) Criteria
  • Free and Clarified Consent Term signature.

Exclusion Criteria:

  • Patients who have other rheumatologic diseases (rheumatoid arthritis, sjogren syndrome, fibromyalgia, ankylosis spondylitis);
  • Systemic Lupus Erythematosus Disease Assessment Index (SLEDAI) > 5;
  • Patients with malignancy;
  • Patients who do not accept the study rules as time and/or follow-up exercise program time proposed;
  • Suspected or pregnancy confirmation;
  • Patients with Inability or unwillingness to understand and/or sign informed consent

Responsible Party: University Hospital, Limoges
ClinicalTrials.gov Identifier: NCT02732470     History of Changes
Other Study ID Numbers: I15023
First Posted: April 8, 2016    Key Record Dates
Last Update Posted: November 2, 2018
Last Verified: March 2018

Keywords provided by University Hospital, Limoges:
Systemic Lupus Erythematous
Qi Gong
Quality of life

Additional relevant MeSH terms:
Lupus Erythematosus, Systemic
Connective Tissue Diseases
Autoimmune Diseases
Immune System Diseases