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

Not Applicable
Completed
Conditions
Fibromyalgia
Interventions
Other: Qigong group
Other: Physiotherapy
Registration Number
NCT04328142
Lead Sponsor
University of Extremadura
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).

Recruitment & Eligibility

Status
COMPLETED
Sex
Female
Target Recruitment
165
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.

Study & Design

Study Type
INTERVENTIONAL
Study Design
PARALLEL
Arm && Interventions
GroupInterventionDescription
QigongQigong groupThe 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.
PhysiotherapyPhysiotherapyThe 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.
Primary Outcome Measures
NameTimeMethod
Change from the Spanish Fibromyalgia Impact Questionnaire (SFIQ) at post intervention (week 6)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.

Changes from the values registered by the Spirobank-G (MIR)® spirometerBaseline (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

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

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

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

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

Secondary Outcome Measures
NameTimeMethod
Change from range of movement measured with goniometerBaseline (week 0), pre intervention (week 1) and post intervention (week 6).

Shoulder and hip range of movement

Change from muscle strength measured with Lovett scaleBaseline (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

Change from flexibility measured with the Wells y Dillon scaleBaseline (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.

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