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

Sponsor
University Hospital, Limoges (Other)
Overall Status
Completed
CT.gov ID
NCT02732470
Collaborator
(none)
33
1
30.2

Study Details

Study Description

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
  • Other: Qi Gong
N/A

Study Design

Study Type:
Interventional
Actual Enrollment :
33 participants
Allocation:
N/A
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 :
Apr 25, 2016
Actual Primary Completion Date :
Apr 10, 2017
Actual Study Completion Date :
Oct 31, 2018

Arms and Interventions

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

Outcome Measures

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 [month 0 - month 6]

Secondary Outcome Measures

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

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

  • University Hospital, Limoges

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
University Hospital, Limoges
ClinicalTrials.gov Identifier:
NCT02732470
Other Study ID Numbers:
  • I15023
First Posted:
Apr 8, 2016
Last Update Posted:
Nov 2, 2018
Last Verified:
Mar 1, 2018
Keywords provided by University Hospital, Limoges
Additional relevant MeSH terms:

Study Results

No Results Posted as of Nov 2, 2018