- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04328142
Effectiveness of Qigong vs. Physiotherapy to Improve Quality of Life of Women With Fibromyalgia
Effectiveness of Qigong vs. Physiotherapy to Improve Quality of Life of Women With Fibromyalgia: A Randomized Controlled Trial
Study Overview
Status
Conditions
Intervention / Treatment
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).
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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 Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Qigong
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.
|
Traditional Chinese Medicine exercise programme
|
Experimental: Physiotherapy
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.
|
Physiotherapy exercise programme
|
No Intervention: Control
The control group did not receive any intervention.
The participants continued with their routine medical treatment.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
|
Baseline (week 0), pre intervention (week 1) and post intervention (week 6).
|
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.
|
Baseline (week 0), pre intervention (week 1) and post intervention (week 6).
|
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.
|
Baseline (week 0), pre intervention (week 1) and post intervention (week 6).
|
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
|
Baseline (week 0), pre intervention (week 1) and post intervention (week 6).
|
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
|
Baseline (week 0), pre intervention (week 1) and post intervention (week 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.
|
Baseline (week 0), pre intervention (week 1) and post intervention (week 6).
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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
|
Baseline (week 0), pre intervention (week 1) and post intervention (week 6).
|
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
|
Baseline (week 0), pre intervention (week 1) and post intervention (week 6).
|
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.
|
Baseline (week 0), pre intervention (week 1) and post intervention (week 6).
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 11//2012
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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