Clinical trial NCT04328142: 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
Overall status: COMPLETED
Phase: NA
Conditions: Fibromyalgia
Keywords: Fibromyalgia
Physiotherapy
Qigong
Quality of life
Lead sponsor: University of Extremadura
Sponsor class: OTHER
First posted: 2020-03-31
Enrollment: 165
Sex: FEMALE
Minimum age (years): 30
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Participants were randomized to a Qigong exercise programme group, a Physiotherapy treatment group and control group for a 6 week study.
Primary purpose: TREATMENT

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).

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.

Primary outcomes:
measure: Change from the Spanish Fibromyalgia Impact Questionnaire (SFIQ) at post intervention (week 6)
timeFrame: Baseline (week 0), pre intervention (week 1) and post intervention (week 6).
measure: Change from Visual Analogue Scale (VAS) at post intervention (week 6)
timeFrame: Baseline (week 0), pre intervention (week 1) and post intervention (week 6).
measure: Change from Borg Scale of perceived exertion at post intervention (week 6)
timeFrame: Baseline (week 0), pre intervention (week 1) and post intervention (week 6).
measure: Changes from the values registered by the Spirobank-G (MIR)® spirometer
timeFrame: Baseline (week 0), pre intervention (week 1) and post intervention (week 6).
measure: Change from the centre of gravity registered with Wii-fit Nintendo®
timeFrame: Baseline (week 0), pre intervention (week 1) and post intervention (week 6).
measure: Change from the monopodal stance test registered with Wii-fit Nintendo®
timeFrame: Baseline (week 0), pre intervention (week 1) and post intervention (week 6).
Secondary outcomes:
measure: Change from range of movement measured with goniometer
timeFrame: Baseline (week 0), pre intervention (week 1) and post intervention (week 6).
measure: Change from muscle strength measured with Lovett scale
timeFrame: Baseline (week 0), pre intervention (week 1) and post intervention (week 6).
measure: Change from flexibility measured with the Wells y Dillon scale
timeFrame: Baseline (week 0), pre intervention (week 1) and post intervention (week 6).
Other outcomes:
Locations:
Study officials:
References: