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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
University Hospital, Limoges
About
Eligibility
Locations
Arms
Outcomes
Full info

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

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

    First Posted
    March 29, 2016
    Last Updated
    October 31, 2018
    Sponsor
    University Hospital, Limoges
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    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

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