FibromyalgiaNCT00961805
Effectiveness of Dance on Patients With Fibromyalgia
A study testing Dance in people with Fibromyalgia, run by Federal University of São Paulo at 1 site in Brazil.
Trial summary
The aim of the present study is to assess the effectiveness of belly dance as a treatment for pain and improving the quality of life of patients with fibromyalgia. Eighty female patients with fibromyalgia between 18 to 65 years were randomly allocated to a dance group (n=40) and control group (n=40). Read more about this study
- Who is it for?
- Ages 18 to 65 years, women only
- Conditions the study is for
- Fibromyalgia
- What is being tested?
- Dance
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteBrazil
- Study dates
- Aug 2007to Nov 2008
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 65 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- classification of fibromyalgia based on the criteria of the American College of Rheumatology
- female gender
- aged between 18 and 65 years
Who cannot join
- not having altered treatment in previous three years
- having signed a term of informed consent
- patients with other rheumatic diseases, painful osteoarticular conditions, uncontrolled cardiopulmonary disease, diseases of the lower limbs or uncontrolled diabetes were excluded
Trial locations and contacts
1 site in 1 country.
About this study
The aim of the present study is to assess the effectiveness of belly dance as a treatment for pain and improving the quality of life of patients with fibromyalgia.
Eighty female patients with fibromyalgia between 18 to 65 years were randomly allocated to a dance group (n=40) and control group (n=40). Patients in the dance group underwent 16 weeks of belly dance twice a week, while the patients in the control group remained on a waiting list. Patients were evaluated with regard to pain (Visual Analogue Scale), function (6 minute walk test), quality of life (Fibromyalgia Impact Questionnaire and SF-36), depression (Beck Inventory), anxiety (State-Trait Anxiety Inventory) and self-image (Body Dysmorphic Disorder Examination) questionnaire. Evaluations were carried out at baseline, after 16 weeks and after 32 weeks.
- Conditions
- Fibromyalgia
- Being tested
- Dance, Control Group
- Keywords
- Fibromyalgia, Treatment, Dance, Randomized controlled study, Exercise
- Medical subject headings
- Fibromyalgia, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DanceBehavioural
Belly dance classes twice a week for 16 weeks. Each class had a maximum of eight students. The classes were administered by a physiotherapist with eight years of experience in belly dance. Classes began with a warm-up exercise, followed by the predetermined movements for the day, choreography and a cool-down exercise. The participants received a compact disc with music and an exercise book with the history and movements proposed for the program. Beginning in the fourth week, a set sequence of movements in the form of choreography was established for memorization and training at home.
Control GroupOther
The control group did not receive any intervention. They attended all assessments and remained on the waiting lis (after the end of the study was offered to this group the same treatment in the intervention group).
| Study group | Role | What they receive |
|---|---|---|
| Dance Group | Experimental | Belly dance Receives: Behavioral: Dance |
| Control Group | No intervention | Waiting list Receives: Other: Control Group |
What is being measured
The primary outcome is the main question the study is designed to answer.
Visual Analog Scale for Pain
score between 0 and 100 where 0 is no pain and 100 in unbearable pain
Measured: baseline, after 16 weeks and after 32 weeks
Secondary outcomes (12)
Function - 6 Minute Walk Test
meters traveled on a 20-meter course over a six-minute period
Measured: baseline, after 16 weeks and after 32 weeks
Quality of Life - Fibromyalgia Impact Questionnaire
score between 0 from 10 with 0 indicating no impairment and 10 indicating maximum impairment
Measured: baseline, after 16 weeks and after 32 weeks
Quality of Life - SF-36 -Functional Capacity
score between 0 from 100, with higher scores denoting better quality of life
Measured: baseline, after 16 weeks and after 32 weeks
Quality of Life - SF-36 - Physical Limitation
score between 0 from 100, with higher scores denoting better quality of life
Measured: baseline, after 16 weeks and after 32 weeks
Quality of Life - Sf-36 - Pain
score between 0 from 100, with higher scores denoting better quality of life
Measured: baseline, after 16 weeks and after 32 weeks
Quality of Life - Sf-36 - General Health State
score between 0 from 100, with higher scores denoting better quality of life
Measured: baseline, after 16 weeks and after 32 weeks
Quality of Life - SF-36 - Vitality
score between 0 from 100, with higher scores denoting better quality of life
Measured: baseline, after 16 weeks and after 32 weeks
Quality of Life - SF-36 - Social Aspects
score between 0 from 100, with higher scores denoting better quality of life
Measured: baseline, after 16 weeks and after 32 weeks
Quality of Life - SF-36 - Emotional Aspects
score between 0 from 100, with higher scores denoting better quality of life
Measured: baseline, after 16 weeks and after 32 weeks
Quality of Life - SF-36 - Mental Health
score between 0 from 100, with higher scores denoting better quality of life
Measured: baseline, after 16 weeks and after 32 weeks
Depression - Beck Inventory
score between 0 from 63, with higher score indicating greater depression
Measured: Baseline, after 16 weeks and after 32 weeks
Self-image - Body Dysmorphic Disorder Examination Questionnaire
scored between 0 from 168, with higher scores indicating greater level of dissatisfaction with self-image
Measured: Baseline, after 16 weeks and after 32 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Aug 2009 (estimated)
- Study startAug 2007
- Primary completionSep 2007
- Study completionNov 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 80 participants (actual)
Sponsor and investigators
- Lead sponsor
- Federal University of São Paulo
- Sponsor type
- University, hospital or other
- Investigators
- Andreia S Baptista, PT, Principal investigator, Federal University of São PauloJamil Natour, MD, Study chair, Federal University of São Paulo
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00961805
- Sponsor's protocol ID
- 1044/06
- Status last verified
- Aug 2009
- First submitted
- 30 Apr 2009
- Last updated
- 25 Aug 2009
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Publications
Baptista AS, Villela AL, Jones A, Natour J. Effectiveness of dance in patients with fibromyalgia: a randomized, single-blind, controlled study. Clin Exp Rheumatol. 2012 Nov-Dec;30(6 Suppl 74):18-23. Epub 2012 Dec 14.
PubMed 23020850
Study at a glance
From the registry record, last updated by the sponsor on 25 Aug 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of Dance on Patients With Fibromyalgia
- ClinicalTrials.gov ID
- NCT00961805
- Acronym / sponsor ID
- 1044/06
- Conditions
- Fibromyalgia
- Keywords
- Fibromyalgia, Treatment, Dance, Randomized controlled study, Exercise
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- Federal University of São PauloUniversity, hospital or other
- Study start
- Aug 2007
- Primary completion
- Sep 2007 (actual)
- Study completion
- Nov 2008 (actual)
- First posted
- 19 Aug 2009 (estimated)
- Results
- Posted 19 Aug 2009
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The aim of the present study is to assess the effectiveness of belly dance as a treatment for pain and improving the quality of life of patients with fibromyalgia.
Eighty female patients with fibromyalgia between 18 to 65 years were randomly allocated to a dance group (n=40) and control group (n=40). Patients in the dance group underwent 16 weeks of belly dance twice a week, while the patients in the control group remained on a waiting list. Patients were evaluated with regard to pain (Visual Analogue Scale), function (6 minute walk test), quality of life (Fibromyalgia Impact Questionnaire and SF-36), depression (Beck Inventory), anxiety (State-Trait Anxiety Inventory) and self-image (Body Dysmorphic Disorder Examination) questionnaire. Evaluations were carried out at baseline, after 16 weeks and after 32 weeks.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Dance Group | Experimental | Behavioral: DanceBelly dance |
| Control Group | No intervention | Other: Control GroupWaiting list |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- classification of fibromyalgia based on the criteria of the American College of Rheumatology
- female gender
- aged between 18 and 65 years
Key exclusion criteria (3 listed)
- not having altered treatment in previous three years
- having signed a term of informed consent
- patients with other rheumatic diseases, painful osteoarticular conditions, uncontrolled cardiopulmonary disease, diseases of the lower limbs or uncontrolled diabetes were excluded
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 |
|---|---|---|
| DanceBelly dance classes twice a week for 16 weeks. Each class had a maximum of eight students. The classes were administered by a physiotherapist with eight years of experience in belly dance. Classes began with a warm-up exercise, followed by the predetermined movements for the day, choreography and a cool-down exercise. The participants received a compact disc with music and an exercise book with the history and movements proposed for the program. Beginning in the fourth week, a set sequence of movements in the form of choreography was established for memorization and training at home. | Behavioural | Dance Group |
| Control GroupThe control group did not receive any intervention. They attended all assessments and remained on the waiting lis (after the end of the study was offered to this group the same treatment in the intervention group). | Other | Control Group |
Primary outcome
Visual Analog Scale for Pain
Time frame: baseline, after 16 weeks and after 32 weeks
score between 0 and 100 where 0 is no pain and 100 in unbearable pain
12 secondary outcomes
Function - 6 Minute Walk Test
Time frame: baseline, after 16 weeks and after 32 weeks
Quality of Life - Fibromyalgia Impact Questionnaire
Time frame: baseline, after 16 weeks and after 32 weeks
Quality of Life - SF-36 -Functional Capacity
Time frame: baseline, after 16 weeks and after 32 weeks
Quality of Life - SF-36 - Physical Limitation
Time frame: baseline, after 16 weeks and after 32 weeks
Quality of Life - Sf-36 - Pain
Time frame: baseline, after 16 weeks and after 32 weeks
Quality of Life - Sf-36 - General Health State
Time frame: baseline, after 16 weeks and after 32 weeks
Quality of Life - SF-36 - Vitality
Time frame: baseline, after 16 weeks and after 32 weeks
Quality of Life - SF-36 - Social Aspects
Time frame: baseline, after 16 weeks and after 32 weeks
Quality of Life - SF-36 - Emotional Aspects
Time frame: baseline, after 16 weeks and after 32 weeks
Quality of Life - SF-36 - Mental Health
Time frame: baseline, after 16 weeks and after 32 weeks
Depression - Beck Inventory
Time frame: Baseline, after 16 weeks and after 32 weeks
Self-image - Body Dysmorphic Disorder Examination Questionnaire
Time frame: Baseline, after 16 weeks and after 32 weeks
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Aug 2009.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 23020850Baptista AS, Villela AL, Jones A, Natour J. Effectiveness of dance in patients with fibromyalgia: a randomized, single-blind, controlled study. Clin Exp Rheumatol. 2012 Nov-Dec;30(6 Suppl 74):18-23. Epub 2012 Dec 14.
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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.
Andreia S Baptista, PT principal investigator
Federal University of São Paulo
Jamil Natour, MD study chair
Federal University of São Paulo
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Dance in people with Fibromyalgia, run by Federal University of São Paulo at 1 site in Brazil.
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 3 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 25 Aug 2009. 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 Brazil. 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.
Are results available for this study?
Yes. Results are posted in the registry (first posted 19 Aug 2009). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Visual Analog Scale for Pain (time frame: baseline, after 16 weeks and after 32 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 NCT00961805, 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 25 Aug 2009.