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Effectiveness of Qigong vs. Physiotherapy to Improve Quality of Life of Women With Fibromyalgia

Primary Purpose

Fibromyalgia

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Qigong group
Physiotherapy
Sponsored by
University of Extremadura
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Fibromyalgia focused on measuring Fibromyalgia, Physiotherapy, Qigong, Quality of life

Eligibility Criteria

30 Years - 65 Years (Adult, Older Adult)FemaleDoes not accept healthy volunteers

Inclusion Criteria:

  • women between 30 and 65 years old,
  • diagnosed with Fibromyalgia by a specialized physician,

Exclusion Criteria:

  • The exclusion criteria were to present any limitation of mobility due to Fibromyalgia or other pathology, previous practice or knowledge of Qi gong, to be under Physiotherapy treatment and to practice any physical exercise.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm 3

    Arm Type

    Experimental

    Experimental

    No Intervention

    Arm Label

    Qigong

    Physiotherapy

    Control

    Arm Description

    The Qigong experimental group performed the 20 figures to improve health and longevity described by the master of Qigong 'Wang Ziping'. These are based on therapeutic exercises of Traditional Chinese Medicine. They work on breathing, flexibility and balance. Each figure was repeated 6 times. The sessions were administered twice a week during 45 minutes and were guided by a Doctor in Western Medicine who is also qualified as a Doctor of Traditional Chinese Medicine and Qigong teacher.

    The physiotherapy experimental group completed an active exercises program guided by a qualified physiotherapist. The exercise programme was based on active shoulder, hips and spine kinesiotherapy. It included a warm up of 3-5 minutes walking, followed by 6 repetitions of shoulder and hip exercises in standing, cervical spine exercises in sitting or standing, according to the comfort of the patient, thoracic and lumbar spine exercises performed in supine on a mat and balance exercises in standing. Stretching exercises were also performed at the end of the session. The exercises were accompanied by gentle breathing coordinated with the movements. The sessions were administered twice a week during 45 minutes.

    The control group did not receive any intervention. The participants continued with their routine medical treatment.

    Outcomes

    Primary Outcome Measures

    Change from the Spanish Fibromyalgia Impact Questionnaire (SFIQ) at post intervention (week 6)
    SFIQ measures the level of quality of life of subjects with Fibromyalgia with a score of 0 to 100. A higher score indicates more impact of the condition on the life of the person and therefore less quality of life.
    Change from Visual Analogue Scale (VAS) at post intervention (week 6)
    The Visual analogue scale measures the level of pain with a score of 0 to 10 where 0 indicates no pain and 10 indicates maximun pain.
    Change from Borg Scale of perceived exertion at post intervention (week 6)
    Borg scale measures the perceived exertion of a subject with a score of 0 to 10 where 0 is the minimum exertion and 10 is the maximun exertion.
    Changes from the values registered by the Spirobank-G (MIR)® spirometer
    Spirometry measures respiratory values being the reference values (Knudson model) for a 50 year old woman with 1,65 cm of height and 65 kilos weight: FVC (Forced vital capacity)= 3.611, FEV1 (Forced expiratory volume) = 2.7505, FEV1%= 76.17%, FEF (Forced expiratory flow) 25-75%= 2.625, PEF (peak expiratory flow)= 6.222
    Change from the centre of gravity registered with Wii-fit Nintendo®
    Static balance and postural control is the ability to maintain the centre of gravity within the base of support. Centre of gravity is measured in percentage through posturography study. A higher percentage means better balance
    Change from the monopodal stance test registered with Wii-fit Nintendo®
    Monopodal stance test measures static balance in percentage through posturography study. It is measure in percentage from 0 to 100 and a higher percentage means a better result.

    Secondary Outcome Measures

    Change from range of movement measured with goniometer
    Shoulder and hip range of movement
    Change from muscle strength measured with Lovett scale
    Shoulder and hip range of movement.Lovett scale is a modification of Daniels and Worthingham. The scale is measured from 0 to 5 where 0 means no muscle activation strength and 5 means normal strength against resistance
    Change from flexibility measured with the Wells y Dillon scale
    Flexibility is measured with this scale with the patient sitting and reaching the feet. It is measured in centimeter and a more positive value means a better record.

    Full Information

    First Posted
    March 27, 2020
    Last Updated
    April 3, 2020
    Sponsor
    University of Extremadura
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    1. Study Identification

    Unique Protocol Identification Number
    NCT04328142
    Brief Title
    Effectiveness of Qigong vs. Physiotherapy to Improve Quality of Life of Women With Fibromyalgia
    Official Title
    Effectiveness of Qigong vs. Physiotherapy to Improve Quality of Life of Women With Fibromyalgia: A Randomized Controlled Trial
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    April 2020
    Overall Recruitment Status
    Completed
    Study Start Date
    March 1, 2012 (Actual)
    Primary Completion Date
    September 30, 2013 (Actual)
    Study Completion Date
    September 30, 2013 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    University of Extremadura

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    No

    5. Study Description

    Brief Summary
    This study analyze the effectiveness of a Physiotherapy treatment versus a Qigong exercise programme improving quality of life of subjects with Fibromyalgia.
    Detailed Description
    Objective: This study investigated the effectiveness of a Physiotherapy treatment versus a Qigong exercise programme for the improvement of the quality of life of subjects with Fibromyalgia. Design: A single-blind randomized clinical controlled trial. Setting: University of Extremadura, Spain Subjects: Women with Fibromyalgia Interventions: 141 Participants were randomized to a Qigong exercise program group (n=47), a physiotherapy treatment group (n=47) and control group (n=47) for 6 weeks. Main Measures: Measures were taken at baseline (week 0), pre intervention (week 1) and post intervention (week 6). The primary outcome measure were quality of life (Spanish Fibromyalgia Impact Questionnaire (SFIQ), pain (VAS), perceive exertion (Borg scale), spirometry measures (Spirobank-G MIR spirometry) and balance (Wii-Fit, Nintendo ©). The secondary outcome measures were flexibility (Wells and Dillon test and Sit and Reach test), Range of movement (goniometer), muscle strength (Lowett scale).

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Fibromyalgia
    Keywords
    Fibromyalgia, Physiotherapy, Qigong, Quality of life

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Model Description
    Participants were randomized to a Qigong exercise programme group, a Physiotherapy treatment group and control group for a 6 week study.
    Masking
    Outcomes Assessor
    Masking Description
    Neither the participants nor their therapists were blind to the treatment allocation. However, the assessor was independent to the study and was not aware of the treatments applied or the objective of the therapy.
    Allocation
    Randomized
    Enrollment
    165 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Qigong
    Arm Type
    Experimental
    Arm Description
    The Qigong experimental group performed the 20 figures to improve health and longevity described by the master of Qigong 'Wang Ziping'. These are based on therapeutic exercises of Traditional Chinese Medicine. They work on breathing, flexibility and balance. Each figure was repeated 6 times. The sessions were administered twice a week during 45 minutes and were guided by a Doctor in Western Medicine who is also qualified as a Doctor of Traditional Chinese Medicine and Qigong teacher.
    Arm Title
    Physiotherapy
    Arm Type
    Experimental
    Arm Description
    The physiotherapy experimental group completed an active exercises program guided by a qualified physiotherapist. The exercise programme was based on active shoulder, hips and spine kinesiotherapy. It included a warm up of 3-5 minutes walking, followed by 6 repetitions of shoulder and hip exercises in standing, cervical spine exercises in sitting or standing, according to the comfort of the patient, thoracic and lumbar spine exercises performed in supine on a mat and balance exercises in standing. Stretching exercises were also performed at the end of the session. The exercises were accompanied by gentle breathing coordinated with the movements. The sessions were administered twice a week during 45 minutes.
    Arm Title
    Control
    Arm Type
    No Intervention
    Arm Description
    The control group did not receive any intervention. The participants continued with their routine medical treatment.
    Intervention Type
    Other
    Intervention Name(s)
    Qigong group
    Intervention Description
    Traditional Chinese Medicine exercise programme
    Intervention Type
    Other
    Intervention Name(s)
    Physiotherapy
    Intervention Description
    Physiotherapy exercise programme
    Primary Outcome Measure Information:
    Title
    Change from the Spanish Fibromyalgia Impact Questionnaire (SFIQ) at post intervention (week 6)
    Description
    SFIQ measures the level of quality of life of subjects with Fibromyalgia with a score of 0 to 100. A higher score indicates more impact of the condition on the life of the person and therefore less quality of life.
    Time Frame
    Baseline (week 0), pre intervention (week 1) and post intervention (week 6).
    Title
    Change from Visual Analogue Scale (VAS) at post intervention (week 6)
    Description
    The Visual analogue scale measures the level of pain with a score of 0 to 10 where 0 indicates no pain and 10 indicates maximun pain.
    Time Frame
    Baseline (week 0), pre intervention (week 1) and post intervention (week 6).
    Title
    Change from Borg Scale of perceived exertion at post intervention (week 6)
    Description
    Borg scale measures the perceived exertion of a subject with a score of 0 to 10 where 0 is the minimum exertion and 10 is the maximun exertion.
    Time Frame
    Baseline (week 0), pre intervention (week 1) and post intervention (week 6).
    Title
    Changes from the values registered by the Spirobank-G (MIR)® spirometer
    Description
    Spirometry measures respiratory values being the reference values (Knudson model) for a 50 year old woman with 1,65 cm of height and 65 kilos weight: FVC (Forced vital capacity)= 3.611, FEV1 (Forced expiratory volume) = 2.7505, FEV1%= 76.17%, FEF (Forced expiratory flow) 25-75%= 2.625, PEF (peak expiratory flow)= 6.222
    Time Frame
    Baseline (week 0), pre intervention (week 1) and post intervention (week 6).
    Title
    Change from the centre of gravity registered with Wii-fit Nintendo®
    Description
    Static balance and postural control is the ability to maintain the centre of gravity within the base of support. Centre of gravity is measured in percentage through posturography study. A higher percentage means better balance
    Time Frame
    Baseline (week 0), pre intervention (week 1) and post intervention (week 6).
    Title
    Change from the monopodal stance test registered with Wii-fit Nintendo®
    Description
    Monopodal stance test measures static balance in percentage through posturography study. It is measure in percentage from 0 to 100 and a higher percentage means a better result.
    Time Frame
    Baseline (week 0), pre intervention (week 1) and post intervention (week 6).
    Secondary Outcome Measure Information:
    Title
    Change from range of movement measured with goniometer
    Description
    Shoulder and hip range of movement
    Time Frame
    Baseline (week 0), pre intervention (week 1) and post intervention (week 6).
    Title
    Change from muscle strength measured with Lovett scale
    Description
    Shoulder and hip range of movement.Lovett scale is a modification of Daniels and Worthingham. The scale is measured from 0 to 5 where 0 means no muscle activation strength and 5 means normal strength against resistance
    Time Frame
    Baseline (week 0), pre intervention (week 1) and post intervention (week 6).
    Title
    Change from flexibility measured with the Wells y Dillon scale
    Description
    Flexibility is measured with this scale with the patient sitting and reaching the feet. It is measured in centimeter and a more positive value means a better record.
    Time Frame
    Baseline (week 0), pre intervention (week 1) and post intervention (week 6).

    10. Eligibility

    Sex
    Female
    Minimum Age & Unit of Time
    30 Years
    Maximum Age & Unit of Time
    65 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: women between 30 and 65 years old, diagnosed with Fibromyalgia by a specialized physician, Exclusion Criteria: The exclusion criteria were to present any limitation of mobility due to Fibromyalgia or other pathology, previous practice or knowledge of Qi gong, to be under Physiotherapy treatment and to practice any physical exercise.

    12. IPD Sharing Statement

    Plan to Share IPD
    No

    Learn more about this trial

    Effectiveness of Qigong vs. Physiotherapy to Improve Quality of Life of Women With Fibromyalgia

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