FibromyalgiaPhase 4NCT00600574
Ai Chi Versus Stretching in Fibromyalgia Management
A Phase 4 study testing physical therapy in people with Fibromyalgia, run by Universidad de Granada at 1 site in Spain.
Trial summary
The purpose of the study is to compare the efficacy and tolerability of Ai Chi, an adaptation of Tai Chi exercise to water, with stretching on fibromyalgia symtomatology. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Fibromyalgia
- What is being tested?
- physical therapy
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 94 participants
- Where
- 1 siteSpain
- Study dates
- Jan 2007to Feb 2008
- Phase
- Phase 4
- 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 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- diagnosis of fibromyalgia according to the ACR criteria
- 18 years or older
- written informed consent to participate
Who cannot join
- unable to tolerate warm chlorinated water
- associated medical condition contraindicating exercise in warm water
Trial locations and contacts
1 site in 1 country.
Spain1 site
Hospital Universitario "Virgen de las Nieves"
Granada, Granada, 18014
About this study
Official title: A Randomized Controlled Trial Comparing the Efficay and Tolerability of Ai Chi Versus Stretching in Fibromyalgia Management: a Six Months Study
The purpose of the study is to compare the efficacy and tolerability of Ai Chi, an adaptation of Tai Chi exercise to water, with stretching on fibromyalgia symtomatology.
Read the detailed description
Physical therapies have shown to be effective in the treatment of fibromyalgia and It is generally assumed that a multidisciplinary approach, combining both pharmacologic and non-pharmacologic measures, is probably the optimal treatment approach for most fibromyalgia patients. As these patients are usually physically deconditioned, low-intensity exercise has been recommended at least as initial treatment. At this respect, exercise in warm water is considered a good option as both temperature and water buoyancy minimize body weight's stress and help patients to minimize pain. In a previous study comparing short term physiotherapy with stretching and Ai Chi we found that Ai Chi was at least as effective as stretching and induced a significant reduction in fibromyalgia core symptomatology and in sleep parameters. The objective of the present randomized controlled study is to compare both physiotherapy techniques in a long term basis.
- Conditions
- Fibromyalgia
- Being tested
- physical therapy
- Keywords
- fibromyalgia, physical therapies, stretching, Ai Chi
- Medical subject headings
- Fibromyalgia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
physical therapyOther
Also called physiotherapy
weekly pool physiotherapy with muscle stretching
physical therapyOther
Also called physiotherapy
weekly pool physiotherapy with Ai Chi movements during a 6 months period
| Study group | Role | What they receive |
|---|---|---|
| S | Active comparator | physiotherapy in warm pool by means of stretching Receives: Other: physical therapy |
| AI | Experimental | physiotherapy in warm pool by means of Ai Chi Receives: Other: physical therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Fibromialgya Impact Questionnaire
Measured: baseline, 6 months, 1 year
Secondary outcomes (5)
Pittsbugh Sleep Quality Index
Measured: baseline, 6 months, 12 months
Hospital Anxiety and Depression Scale
Measured: baseline, 6 months, 12 months
SF-36 Health Survey
Measured: baseline, 6 months, 12 months
Brief Pain Inventory
Measured: baseline, 6 months, 12 months
Adverse reaction recording
Measured: baseline, 6 months, 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jan 2008 (estimated)
- Study startJan 2007
- Primary completionFeb 2008
- Study completionFeb 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 94 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universidad de Granada
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Elena Pita Calandre, Universidad de Granada
- Investigators
- Elena P. Calandre, M.D., Study director, Universidad de Granada
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00600574
- Sponsor's protocol ID
- ML-2007
- Status last verified
- Dec 2014
- First submitted
- 14 Jan 2008
- Last updated
- 3 Dec 2014
- Results posted
- No
- Data monitoring committee
- No
Publications
Gowans SE, deHueck A. Pool exercise for individuals with fibromyalgia. Curr Opin Rheumatol. 2007 Mar;19(2):168-73. doi: 10.1097/BOR.0b013e3280327944.
PubMed 17278933
Study at a glance
From the registry record, last updated by the sponsor on 3 Dec 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Controlled Trial Comparing the Efficay and Tolerability of Ai Chi Versus Stretching in Fibromyalgia Management: a Six Months Study
- ClinicalTrials.gov ID
- NCT00600574
- Acronym / sponsor ID
- ML-2007
- Conditions
- Fibromyalgia
- Keywords
- fibromyalgia, physical therapies, stretching, Ai Chi
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 94 participants (actual)
- Lead sponsor
- Universidad de GranadaUniversity, hospital or other
- Study start
- Jan 2007
- Primary completion
- Feb 2008 (actual)
- Study completion
- Feb 2008 (actual)
- First posted
- 25 Jan 2008 (estimated)
- 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.
The purpose of the study is to compare the efficacy and tolerability of Ai Chi, an adaptation of Tai Chi exercise to water, with stretching on fibromyalgia symtomatology.
Detailed description
Physical therapies have shown to be effective in the treatment of fibromyalgia and It is generally assumed that a multidisciplinary approach, combining both pharmacologic and non-pharmacologic measures, is probably the optimal treatment approach for most fibromyalgia patients. As these patients are usually physically deconditioned, low-intensity exercise has been recommended at least as initial treatment. At this respect, exercise in warm water is considered a good option as both temperature and water buoyancy minimize body weight's stress and help patients to minimize pain. In a previous study comparing short term physiotherapy with stretching and Ai Chi we found that Ai Chi was at least as effective as stretching and induced a significant reduction in fibromyalgia core symptomatology and in sleep parameters. The objective of the present randomized controlled study is to compare both physiotherapy techniques in a long term basis.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| S | Active comparator | Other: physical therapyphysiotherapy in warm pool by means of stretching |
| AI | Experimental | Other: physical therapyphysiotherapy in warm pool by means of Ai Chi |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- diagnosis of fibromyalgia according to the ACR criteria
- 18 years or older
- written informed consent to participate
Key exclusion criteria (2 listed)
- unable to tolerate warm chlorinated water
- associated medical condition contraindicating exercise in warm water
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 |
|---|---|---|
| physical therapyAlso: physiotherapyweekly pool physiotherapy with muscle stretching | Other | S |
| physical therapyAlso: physiotherapyweekly pool physiotherapy with Ai Chi movements during a 6 months period | Other | AI |
Primary outcome
Fibromialgya Impact Questionnaire
Time frame: baseline, 6 months, 1 year
5 secondary outcomes
Pittsbugh Sleep Quality Index
Time frame: baseline, 6 months, 12 months
Hospital Anxiety and Depression Scale
Time frame: baseline, 6 months, 12 months
SF-36 Health Survey
Time frame: baseline, 6 months, 12 months
Brief Pain Inventory
Time frame: baseline, 6 months, 12 months
Adverse reaction recording
Time frame: baseline, 6 months, 12 months
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 3 Dec 2014.
- Background: PubMed 17278933Gowans SE, deHueck A. Pool exercise for individuals with fibromyalgia. Curr Opin Rheumatol. 2007 Mar;19(2):168-73. doi: 10.1097/BOR.0b013e3280327944.
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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.
Elena P. Calandre, M.D. study director
Universidad de Granada
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing physical therapy in people with Fibromyalgia, run by Universidad de Granada at 1 site in Spain.
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 3 inclusion and 2 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 3 Dec 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Fibromialgya Impact Questionnaire (time frame: baseline, 6 months, 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00600574, which also lists 1 linked publication.
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 3 Dec 2014.