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

October 31, 2018 updated by: University Hospital, Limoges

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

33

Phase

  • Not Applicable

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

Ages Eligible for Study

16 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

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: Prevention
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
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
month 0 - month 6

Secondary Outcome Measures

Outcome Measure
Time Frame
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
months 0, months 2, months 4, months 9 and months 12

Collaborators and Investigators

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

Sponsor

University Hospital, Limoges

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)

April 25, 2016

Primary Completion (Actual)

April 10, 2017

Study Completion (Actual)

October 31, 2018

Study Registration Dates

First Submitted

March 29, 2016

First Submitted That Met QC Criteria

April 7, 2016

First Posted (Estimate)

April 8, 2016

Study Record Updates

Last Update Posted (Actual)

November 2, 2018

Last Update Submitted That Met QC Criteria

October 31, 2018

Last Verified

March 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • I15023

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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