FibromyalgiaNCT03971890
Effectiveness of Dance Therapy in Fibromyalgia.
A study testing Dance therapy and Educational group in people with Fibromyalgia, run by Universidad de Granada at 1 site in Spain.
Trial summary
The purpose of this study is to analyze the effects of an intervention with dance on balance,movility, pain and sleep in patients with Fibromyalgia in comparison to a control group that will have an educational intervention. Read more about this study
- Who is it for?
- Ages 18 to 64 years, women only
- Conditions the study is for
- Fibromyalgia
- What is being tested?
- Dance therapy and Educational group
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 70 participants
- Where
- 1 siteSpain
- Study dates
- 22 Apr 2019to 21 Sep 2019
- 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 18 to 64 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- Being over 18 years of age until 64.
- Being diagnosed with FMS in accordance with American College of Rheumatology - ACR
Who cannot join
- Participants with diagnoses of other inflammatory rheumatic diseases, previous neurological or orthopedic diseases,
- Use aids for balance, hearing and visual problems.
- Cognitive impairment.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effectiveness of a Exercise Program Based on Dance Therapy in Fibromyalgia: A Randomized Controlled Trial.
The purpose of this study is to analyze the effects of an intervention with dance on balance,movility, pain and sleep in patients with Fibromyalgia in comparison to a control group that will have an educational intervention.
Read the detailed description
Fibromyalgia is a chronic disease consisting of widespread pain, fatigue, sleep disturbances, and cognitive impairments, among other symptoms, which affect daily physical activity.
The regular physical exercise improves the functional, physiological, and behavioral components of physical fitness. Dance therapy seems to increase motivation and adherence to therapy, and can provide a real alternative to conventional exercise
The experimental group will receive a dance program treatment .
The control group will receive an educational intervention.
- Conditions
- Fibromyalgia
- Being tested
- Dance therapy, Educational group
- Keywords
- Balance, Pain, TUG, Dance
- Medical subject headings
- Fibromyalgia, Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dance therapyOther
Also called Exercise treatment
The experimental group will receive a dance treatment.This protocol will be administered at weekly sessions of 60 minutes with a period of 2 times / week with a total of 16 sessions, distributed over a 8-week period. They will be evaluated at baseline, after the end of the last treatment session.
Educational groupOther
Also called Control group
The control group will receive an educational intervention. They will be evaluated at baseline, after the end of the last treatment session.
| Study group | Role | What they receive |
|---|---|---|
| DanceTherapy Group | Experimental | The experimental group will receive a dance treatment. Receives: Other: Dance therapy |
| Control Group | Experimental | The control group will be subjected to a educational treatment. Receives: Other: Educational group |
What is being measured
The primary outcome is the main question the study is designed to answer.
Timed Up and Go (TUG)
Change from de baseline in functional mobility and predict risk of falls. The single-task subscale consists of a measurement of the time in seconds for the patient to rise from sitting in a standard arm chair, walk 3 meters, turn, walk back to the chair, and sit down. The dual task subscale adds a cognitive task (TUGCognitive) or a manual task (TUGManual) to the simple task.
Measured: 8 weeks
Secondary outcomes (11)
One leg stance
Change from de baseline in postural steadiness (static balance) in a static position by registering the number of seconds a person can maintain this position.
Measured: 8 weeks
SLUMP Test
Change from de baseline in the movement of the pain-sensitive nerve structures.
Measured: 8 weeks
Straight Leg Raise test (SLR)
Change from de baseline in the movement of the pain-sensitive nerve structures.
Measured: 8 weeks
Revised Fibromyalgia Impact Questionnaire (FIQR)
Change from the baseline on the impact of symptoms on quality of life in people with fibromyalgia. Questionnaire with 21-items on a visual analogue scale.
Measured: 8 weeks
Sheehan Disability Scale (SDS)
Change from the baseline on the severity of general disability in the items of work, family life/home responsibilities and social life/leisure activities.
Measured: 8 weeks
Pittsburgh Sleep Quality Index (PSQI)
change from the baseline on sleep quality. The self-rated items of the PSQI generate seven component scores (with subscales ranged 0-3): sleep quality, sleep latency, sleep duration, habitual sleep efficiency, sleep disturbance, use of sleeping medication, and daytime dysfunction.
Measured: 8 weeks
Athens Insomnia Scale (AIS)
Change from the baseline on insomnia. It is a self-rating instrument of eigth items.
Measured: 8 weeks
Spanish version of the Brief Pain Inventory questionnaire (CBD)
Change from the baseline on the intensity of pain and its impact on activities of daily living.
Measured: 8 weeks
Health Assessment Questionnaire - Disability Index (HAQ-DI)
Change from the baseline on physical disability related to activities of eight categories of daily living over the last week.
Measured: 8 weeks
Epworth Sleepiness Scale, (EES)
Change from thebaseline of the subject's general level of daytime sleepiness.
Measured: 8 weeks
Minibestest
Change from baseline in Dynamic Balance: areas are anticipatory postural adjustments, reactive postural responses, sensory orientation, and stability in gait. This tool has 14 items, with a maximum score of 28 points.
Measured: 8 Weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Jun 2019
- Study start22 Apr 2019
- Primary completion21 Aug 2019
- Study completion21 Sep 2019
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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 70 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universidad de Granada
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Encarnación Aguilar Ferrandiz, Universidad de Granada
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03971890
- Sponsor's protocol ID
- ExerFib
- Status last verified
- Sep 2019
- First submitted
- 31 May 2019
- Last updated
- 1 Oct 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Oct 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of a Exercise Program Based on Dance Therapy in Fibromyalgia: A Randomized Controlled Trial.
- ClinicalTrials.gov ID
- NCT03971890
- Acronym / sponsor ID
- ExerFib
- Conditions
- Fibromyalgia
- Keywords
- Balance, Pain, TUG, Dance
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 70 participants (actual)
- Lead sponsor
- Universidad de GranadaUniversity, hospital or other
- Study start
- 22 Apr 2019 (actual)
- Primary completion
- 21 Aug 2019 (actual)
- Study completion
- 21 Sep 2019 (actual)
- First posted
- 3 Jun 2019 (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.
The purpose of this study is to analyze the effects of an intervention with dance on balance,movility, pain and sleep in patients with Fibromyalgia in comparison to a control group that will have an educational intervention.
Detailed description
Fibromyalgia is a chronic disease consisting of widespread pain, fatigue, sleep disturbances, and cognitive impairments, among other symptoms, which affect daily physical activity.
The regular physical exercise improves the functional, physiological, and behavioral components of physical fitness. Dance therapy seems to increase motivation and adherence to therapy, and can provide a real alternative to conventional exercise
The experimental group will receive a dance program treatment .
The control group will receive an educational intervention.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| DanceTherapy Group | Experimental | Other: Dance therapyThe experimental group will receive a dance treatment. |
| Control Group | Experimental | Other: Educational groupThe control group will be subjected to a educational treatment. |
Who may qualify
- Ages
- 18 to 64 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Being over 18 years of age until 64.
- Being diagnosed with FMS in accordance with American College of Rheumatology - ACR
Key exclusion criteria (3 listed)
- Participants with diagnoses of other inflammatory rheumatic diseases, previous neurological or orthopedic diseases,
- Use aids for balance, hearing and visual problems.
- Cognitive impairment.
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 |
|---|---|---|
| Dance therapyAlso: Exercise treatmentThe experimental group will receive a dance treatment.This protocol will be administered at weekly sessions of 60 minutes with a period of 2 times / week with a total of 16 sessions, distributed over a 8-week period. They will be evaluated at baseline, after the end of the last treatment session. | Other | DanceTherapy Group |
| Educational groupAlso: Control groupThe control group will receive an educational intervention. They will be evaluated at baseline, after the end of the last treatment session. | Other | Control Group |
Primary outcome
Timed Up and Go (TUG)
Time frame: 8 weeks
Change from de baseline in functional mobility and predict risk of falls. The single-task subscale consists of a measurement of the time in seconds for the patient to rise from sitting in a standard arm chair, walk 3 meters, turn, walk back to the chair, and sit down. The dual task subscale adds a cognitive task (TUGCognitive) or a manual task (TUGManual) to the simple task.
11 secondary outcomes
One leg stance
Time frame: 8 weeks
SLUMP Test
Time frame: 8 weeks
Straight Leg Raise test (SLR)
Time frame: 8 weeks
Revised Fibromyalgia Impact Questionnaire (FIQR)
Time frame: 8 weeks
Sheehan Disability Scale (SDS)
Time frame: 8 weeks
Pittsburgh Sleep Quality Index (PSQI)
Time frame: 8 weeks
Athens Insomnia Scale (AIS)
Time frame: 8 weeks
Spanish version of the Brief Pain Inventory questionnaire (CBD)
Time frame: 8 weeks
Health Assessment Questionnaire - Disability Index (HAQ-DI)
Time frame: 8 weeks
Epworth Sleepiness Scale, (EES)
Time frame: 8 weeks
Minibestest
Time frame: 8 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 1 Oct 2019.
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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.
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 therapy and Educational group 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 2 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 1 Oct 2019. 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.
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?
Timed Up and Go (TUG) (time frame: 8 weeks). 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 1 Oct 2019.