FibromyalgiaNCT04328142
Effectiveness of Qigong vs. Physiotherapy to Improve Quality of Life of Women With Fibromyalgia
A study testing Qigong group and Physiotherapy in people with Fibromyalgia, run by University of Extremadura.
Trial summary
This study analyze the effectiveness of a Physiotherapy treatment versus a Qigong exercise programme improving quality of life of subjects with Fibromyalgia. Read more about this study
- Who is it for?
- Ages 30 to 65 years, women only
- Conditions the study is for
- Fibromyalgia
- What is being tested?
- Qigong group and Physiotherapy
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 165 participants
- Where
- No sites listed yet
- Study dates
- 1 Mar 2012to 30 Sep 2013
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 30 to 65 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- women between 30 and 65 years old,
- diagnosed with Fibromyalgia by a specialized physician,
Who cannot join
- 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.
About this study
Official title: Effectiveness of Qigong vs. Physiotherapy to Improve Quality of Life of Women With Fibromyalgia: A Randomized Controlled Trial
This study analyze the effectiveness of a Physiotherapy treatment versus a Qigong exercise programme improving quality of life of subjects with Fibromyalgia.
Read the 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).
- Conditions
- Fibromyalgia
- Being tested
- Qigong group, Physiotherapy
- Keywords
- Fibromyalgia, Physiotherapy, Qigong, Quality of life
- Medical subject headings
- Fibromyalgia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Qigong groupOther
Traditional Chinese Medicine exercise programme
PhysiotherapyOther
Physiotherapy exercise programme
| Study group | Role | What they receive |
|---|---|---|
| Qigong | Experimental | 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. Receives: Other: Qigong group |
| Physiotherapy | Experimental | 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. Receives: Other: Physiotherapy |
| Control | No intervention | The control group did not receive any intervention. The participants continued with their routine medical treatment. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline (week 0), pre intervention (week 1) and post intervention (week 6).
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.
Measured: Baseline (week 0), pre intervention (week 1) and post intervention (week 6).
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.
Measured: Baseline (week 0), pre intervention (week 1) and post intervention (week 6).
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
Measured: Baseline (week 0), pre intervention (week 1) and post intervention (week 6).
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
Measured: Baseline (week 0), pre intervention (week 1) and post intervention (week 6).
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.
Measured: Baseline (week 0), pre intervention (week 1) and post intervention (week 6).
Secondary outcomes (3)
Change from range of movement measured with goniometer
Shoulder and hip range of movement
Measured: Baseline (week 0), pre intervention (week 1) and post intervention (week 6).
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
Measured: Baseline (week 0), pre intervention (week 1) and post intervention (week 6).
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.
Measured: Baseline (week 0), pre intervention (week 1) and post intervention (week 6).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Mar 2020
- Study start1 Mar 2012
- Primary completion30 Sep 2013
- Study completion30 Sep 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for FibromyalgiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Participants were randomized to a Qigong exercise programme group, a Physiotherapy treatment group and control group for a 6 week study.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 165 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Extremadura
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Abel Mejías Gil, University of Extremadura
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04328142
- Sponsor's protocol ID
- 11//2012
- Status last verified
- Apr 2020
- First submitted
- 27 Mar 2020
- Last updated
- 7 Apr 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Apr 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of Qigong vs. Physiotherapy to Improve Quality of Life of Women With Fibromyalgia: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT04328142
- Acronym / sponsor ID
- 11//2012
- Conditions
- Fibromyalgia
- Keywords
- Fibromyalgia, Physiotherapy, Qigong, Quality of life
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 165 participants (actual)
- Lead sponsor
- University of ExtremaduraUniversity, hospital or other
- Study start
- 1 Mar 2012 (actual)
- Primary completion
- 30 Sep 2013 (actual)
- Study completion
- 30 Sep 2013 (actual)
- First posted
- 31 Mar 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
- Model description
- Participants were randomized to a Qigong exercise programme group, a Physiotherapy treatment group and control group for a 6 week study.
| Arm | Type | Receives |
|---|---|---|
| Qigong | Experimental | Other: Qigong 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. |
| Physiotherapy | Experimental | Other: PhysiotherapyThe 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. |
| Control | No intervention | –The control group did not receive any intervention. The participants continued with their routine medical treatment. |
Who may qualify
- Ages
- 30 to 65 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- women between 30 and 65 years old,
- diagnosed with Fibromyalgia by a specialized physician,
Key exclusion criteria (1 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Qigong groupTraditional Chinese Medicine exercise programme | Other | Qigong |
| PhysiotherapyPhysiotherapy exercise programme | Other | Physiotherapy |
Primary outcome
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.
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.
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.
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
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
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.
3 secondary outcomes
Change from range of movement measured with goniometer
Time frame: 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).
Change from flexibility measured with the Wells y Dillon scale
Time frame: Baseline (week 0), pre intervention (week 1) and post intervention (week 6).
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Apr 2020.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing Qigong group and Physiotherapy in people with Fibromyalgia, run by University of Extremadura.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 7 Apr 2020. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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).). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Apr 2020.