Effect of Qi Gong Training on Quality of Life in Patients With Systemic Lupus Erythematous (LuQi) (LuQi)
Primary Purpose
Lupus Erythematosus, Systemic
Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Qi Gong
Sponsored by
About this trial
This is an interventional prevention trial for Lupus Erythematosus, Systemic focused on measuring Systemic Lupus Erythematous, Qi Gong, Quality of life
Eligibility 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
Sites / Locations
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Qi Gong
Arm Description
The effect of Qi Gong training on quality of life in patients with systemic lupus erythematosus
Outcomes
Primary Outcome Measures
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
Secondary Outcome Measures
Quality of life (SF-36), quality of life in patients with SLE
Full Information
NCT ID
NCT02732470
First Posted
March 29, 2016
Last Updated
October 31, 2018
Sponsor
University Hospital, Limoges
1. Study Identification
Unique Protocol Identification Number
NCT02732470
Brief Title
Effect of Qi Gong Training on Quality of Life in Patients With Systemic Lupus Erythematous (LuQi)
Acronym
LuQi
Official Title
Effect of Qi Gong Training on Quality of Life in Patients With Systemic Lupus Erythematous (LuQi)
Study Type
Interventional
2. Study Status
Record Verification Date
March 2018
Overall Recruitment Status
Completed
Study Start Date
April 25, 2016 (Actual)
Primary Completion Date
April 10, 2017 (Actual)
Study Completion Date
October 31, 2018 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Hospital, Limoges
4. Oversight
Data Monitoring Committee
No
5. 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Lupus Erythematosus, Systemic
Keywords
Systemic Lupus Erythematous, Qi Gong, Quality of life
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
33 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Qi Gong
Arm Type
Experimental
Arm Description
The effect of Qi Gong training on quality of life in patients with systemic lupus erythematosus
Intervention Type
Other
Intervention Name(s)
Qi Gong
Intervention Description
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 Measure Information:
Title
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 Measure Information:
Title
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
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
12. IPD Sharing Statement
Learn more about this trial
Effect of Qi Gong Training on Quality of Life in Patients With Systemic Lupus Erythematous (LuQi)
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