FibromyalgiaPhase 4NCT00550641
Pool-based Exercise 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
Pharmacologic treatment remains the primary therapeutic approach in fibromyalgia management, but different non-pharmacologic measures, especially physical therapies and psychologically-based interventions, have also shown to be effective in the treatment of this disease. 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
- 90 participants
- Where
- 1 siteSpain
- Study dates
- Mar 2006to Dec 2006
- 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, 18012
About this study
Official title: Pool-based Exercise in Fibromyalgia Management: a Prospective Randomized Comparison Between Stretching and Ai Chi
Pharmacologic treatment remains the primary therapeutic approach in fibromyalgia management, but different non-pharmacologic measures, especially physical therapies and psychologically-based interventions, have also shown to be effective in the treatment of this disease. The objective of the present randomized controlled trial is to compare the efficacy and tolerability of two different modalities of active low-impact exercise in warm water: stretching and Ai Chi. Each group of patients will receive 18 physiotherapy sessions lasting 60 minutes and will be evaluated at baseline, at treatment termination, and after 4 and 12 weeks of follow up. Main outcome measures are the Fibromyalgia Impact Questionnaire (FIQ) and the Pittsburgh Sleep Quality Index (PSQI). Secondary outcome measures include the Beck Depression Inventory (BDI), the State and Trait Anxiety Inventory (STAI), and the SF-12 Health Survey (SF-12. Data analysis will be done using repeated measures ANOVA, unpaired Student's t test, and effect sizes' estimation (ES).
- Conditions
- Fibromyalgia
- Being tested
- physical therapy
- Keywords
- fibromyalgia, pool-based exercise
- 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
physical therapy in warm pool performing stretching
physical therapyOther
physical therapy in warm pool performing Ai Chi
| Study group | Role | What they receive |
|---|---|---|
| 1 | Active comparator | Not described Receives: Other: physical therapy |
| 2 | Experimental | Not described Receives: Other: physical therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Improvement in fibromyalgia symptomatology
Measured: 18 weeks
Secondary outcomes (1)
Improvement in sleep, depressive and anxiety symptomatology and quality of life
Measured: 18 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Oct 2007 (estimated)
- Study startMar 2006
- Study completionDec 2006
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
- 90 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universidad de Granada
- Sponsor type
- University, hospital or other
- Investigators
- Elena P. Calandre, Study director, Professor of Clinical PharmacologyMª Luz Rodriguez-Claro, Principal investigator, physiotherapist
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00550641
- Sponsor's protocol ID
- ML-2006
- Status last verified
- Sep 2007
- First submitted
- 26 Oct 2007
- Last updated
- 6 Apr 2010
- Results posted
- No
- Data monitoring committee
- No
Publications
Calandre EP, Rodriguez-Claro ML, Rico-Villademoros F, Vilchez JS, Hidalgo J, Delgado-Rodriguez A. Effects of pool-based exercise in fibromyalgia symptomatology and sleep quality: a prospective randomised comparison between stretching and Ai Chi. Clin Exp Rheumatol. 2009 Sep-Oct;27(5 Suppl 56):S21-8.
PubMed 20074435
Study at a glance
From the registry record, last updated by the sponsor on 6 Apr 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pool-based Exercise in Fibromyalgia Management: a Prospective Randomized Comparison Between Stretching and Ai Chi
- ClinicalTrials.gov ID
- NCT00550641
- Acronym / sponsor ID
- ML-2006
- Conditions
- Fibromyalgia
- Keywords
- fibromyalgia, pool-based exercise
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 90 participants (actual)
- Lead sponsor
- Universidad de GranadaUniversity, hospital or other
- Study start
- Mar 2006
- Study completion
- Dec 2006 (actual)
- First posted
- 30 Oct 2007 (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.
Pharmacologic treatment remains the primary therapeutic approach in fibromyalgia management, but different non-pharmacologic measures, especially physical therapies and psychologically-based interventions, have also shown to be effective in the treatment of this disease. The objective of the present randomized controlled trial is to compare the efficacy and tolerability of two different modalities of active low-impact exercise in warm water: stretching and Ai Chi. Each group of patients will receive 18 physiotherapy sessions lasting 60 minutes and will be evaluated at baseline, at treatment termination, and after 4 and 12 weeks of follow up. Main outcome measures are the Fibromyalgia Impact Questionnaire (FIQ) and the Pittsburgh Sleep Quality Index (PSQI). Secondary outcome measures include the Beck Depression Inventory (BDI), the State and Trait Anxiety Inventory (STAI), and the SF-12 Health Survey (SF-12. Data analysis will be done using repeated measures ANOVA, unpaired Student's t test, and effect sizes' estimation (ES).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Active comparator | Other: physical therapy |
| 2 | Experimental | Other: physical therapy |
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 therapyphysical therapy in warm pool performing stretching | Other | 1 |
| physical therapyphysical therapy in warm pool performing Ai Chi | Other | 2 |
Primary outcome
Improvement in fibromyalgia symptomatology
Time frame: 18 weeks
1 secondary outcome
Improvement in sleep, depressive and anxiety symptomatology and quality of life
Time frame: 18 weeks
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 6 Apr 2010.
- Results publication: PubMed 20074435Calandre EP, Rodriguez-Claro ML, Rico-Villademoros F, Vilchez JS, Hidalgo J, Delgado-Rodriguez A. Effects of pool-based exercise in fibromyalgia symptomatology and sleep quality: a prospective randomised comparison between stretching and Ai Chi. Clin Exp Rheumatol. 2009 Sep-Oct;27(5 Suppl 56):S21-8.
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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 study director
Professor of Clinical Pharmacology
Mª Luz Rodriguez-Claro principal investigator
physiotherapist
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 6 Apr 2010. 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?
Improvement in fibromyalgia symptomatology (time frame: 18 weeks). 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 NCT00550641, 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 6 Apr 2010.