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NCT Number: NCT04328142

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

This study analyze the effectiveness of a Physiotherapy treatment versus a Qigong exercise programme improving quality of life of subjects with Fibromyalgia.

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Key information

Conditions

Fibromyalgia Muscular Diseases Musculoskeletal Diseases Nervous System Diseases Neuromuscular Diseases Rheumatic Diseases

Age range

30 year–65 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

About this study

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).

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Qigong group

Other

Traditional Chinese Medicine exercise programme

Physiotherapy

Other

Physiotherapy exercise programme

Primary outcomes

  1. Change from the Spanish Fibromyalgia Impact Questionnaire (SFIQ) at post intervention (week 6)

    Time frame: Baseline (week 0), pre intervention (week 1) and 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.

  2. Change from Visual Analogue Scale (VAS) at post intervention (week 6)

    Time frame: Baseline (week 0), pre intervention (week 1) and 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.

  3. Change from Borg Scale of perceived exertion at post intervention (week 6)

    Time frame: Baseline (week 0), pre intervention (week 1) and 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.

  4. Changes from the values registered by the Spirobank-G (MIR)® spirometer

    Time frame: Baseline (week 0), pre intervention (week 1) and post intervention (week 6).

    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

  5. Change from the centre of gravity registered with Wii-fit Nintendo®

    Time frame: Baseline (week 0), pre intervention (week 1) and post intervention (week 6).

    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

  6. Change from the monopodal stance test registered with Wii-fit Nintendo®

    Time frame: Baseline (week 0), pre intervention (week 1) and post intervention (week 6).

    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 outcomes

  1. Change from range of movement measured with goniometer

    Time frame: Baseline (week 0), pre intervention (week 1) and post intervention (week 6).

    Shoulder and hip range of movement

  2. Change from muscle strength measured with Lovett scale

    Time frame: Baseline (week 0), pre intervention (week 1) and post intervention (week 6).

    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

  3. Change from flexibility measured with the Wells y Dillon scale

    Time frame: Baseline (week 0), pre intervention (week 1) and post intervention (week 6).

    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.

Sponsors and collaborators

Lead sponsor

University of Extremadura

Other

Registry information

Official study title

Effectiveness of Qigong vs. Physiotherapy to Improve Quality of Life of Women With Fibromyalgia: A Randomized Controlled Trial

Important dates

Study start
2012
Primary completion
2013
Study completion
2013
First posted
Mar 31, 2020
Registry last updated
Apr 7, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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