FibromyalgiaEffMusFibroNCT02516761
Effect of Low-impact Aerobic Exercise and Music Therapy in Fibromyalgia
A study testing Low-impact aerobic exercise combined with music therapy and Low-impact aerobic exercise in people with Fibromyalgia, run by University of Valencia at 1 site in Spain.
Trial summary
The idea of this study is the combination of these two techniques (low-impact aerobic exercise through functional movements and music therapy) that have proven to be effective separately. Read more about this study
- Who is it for?
- Ages 30 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Fibromyalgia
- What is being tested?
- Low-impact aerobic exercise combined with music therapy and Low-impact aerobic exercise
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 26 participants
- Where
- 1 siteSpain
- Study dates
- Jul 2015to Mar 2016
- 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 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- To be between 30 and 80 years old.
- Meet the new diagnostic criteria for fibromyalgia of the ACR..
- Meet some or several of the following characteristics:
- Depression
- Anxiety
- Muscle pain
Show all 9Show fewer
- Fatigue
- Sleep disturbance
- May have limited mobility as long as it is caused by fibromyalgia.
Who cannot join
- Medical contraindication for physical activity (locomotor disorder, uncontrolled cardiovascular disease, ...)
- Deafness or limited hearing
- Vestibular disorders that compromise balance.
- Very low visibility or blind people.
- Psychiatric disorders or excessive emotional tension that could alter the dynamics of the study (psychotic disorder)
- Cognitive disabilities
- Decompensation or changes in medication.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effect of Low-impact Aerobic Exercise Combined With Music Therapy in Patients With Fibromyalgia
The idea of this study is the combination of these two techniques (low-impact aerobic exercise through functional movements and music therapy) that have proven to be effective separately. The main objective of this study is to test this combination to reduce widespread pain in fibromyalgia patients, improve their balance, influence on decreasing levels of depression and improve quality of life.
Read the detailed description
Material and methods Patients The sample includes volunteer subjects diagnosed with fibromyalgia from the Valencian Association of People Affected by Fibromyalgia that were submitted to participate in the study.
Study design It is a quasi-experimental, longitudinal, prospective, controlled, randomized, single-blinded research. The sample was divided into 3 groups. Patients signed informed consent and then the randomization of subjects to the different study groups was done through computer software by an external assistant who was blinded to the study objectives. The study was conducted in morning and afternoon sessions.
All those patients who belong to the experimental group 1 or 2 attend their sessions which last 60 minutes and are held 2 times a week every other day. The experimental group 1 attends classes in the morning, while the experimental group 2 attends them in the evenings. The control group only comes to the evaluation sessions without doing any particular activity. The subjects are evaluated in two stages, at baseline and after completion of the study.
Intervention Group 1 (G1): Low-impact aerobic exercise combined with music therapy. Intervention consists in working the muscles which are mostly affected by fibromyalgia through group exercises, which are dynamic, smooth and aim functionality.
Group 2 (G2): Low-impact aerobic exercise. Then intervention is like the previous group but with the difference that physical activity is not performed to the rhythm of chosen melodic music. Therefore, exercises are done with general chill-out music throughout the session, without adaptation of the exercise to the music.
Control group (CG): With this group no intervention is done, but they are assessed like the other groups.
Evaluation:
Depression, by Beck Depression Inventory, General discomfort, using the Faces Pain Scale, Balance, evaluated by the Berg Scale.
- Conditions
- Fibromyalgia
- Being tested
- Low-impact aerobic exercise combined with music therapy, Low-impact aerobic exercise, Control group
- Keywords
- Fibromyalgia
- Medical subject headings
- Fibromyalgia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Low-impact aerobic exercise combined with music therapyOther
Intervention consists in working the muscles which are mostly affected by fibromyalgia through group exercises, which are dynamic, smooth and aim functionality. Each session consists of 60 minutes with 3 parts: initial warming up time, main part through games, group dynamics and pure aerobic workout, and final cool down with stretching. This exercise is done to the rhythm of melodic music, adapted to the tastes of the participants and also adapted on the way to perform the exercise. For this, they were shown a list of 100 music compositions from which participants choose a minimum of 20 preferences. All exercises are performed with proper postural control both dissociated and global and within a framework of therapeutic proprioceptive gymnastics.
Low-impact aerobic exerciseOther
Low-impact aerobic exercise. Then intervention is like the previous group but with the difference that physical activity is not performed to the rhythm of chosen melodic music. Therefore, exercises are done with general chill-out music throughout the session, without adaptation of the exercise to the music.
Control groupOther
With this group no intervention is done, but they are assessed like the other groups.
| Study group | Role | What they receive |
|---|---|---|
| Low-impact aerobic exercise combined with music therapy | Experimental | Intervention consists in working the muscles which are mostly affected by fibromyalgia through group exercises, which are dynamic, smooth and aim functionality. This exercise is done to the rhythm of melodic music, adapted to the tastes of the participants and also adapted on the way to perform the exercise. Receives: Other: Low-impact aerobic exercise combined with music therapy |
| Low-impact aerobic exercise | Experimental | Then intervention is like the previous group but with the difference that physical activity is not performed to the rhythm of chosen melodic music. Therefore, exercises are done with general chill-out music throughout the session, without adaptation of the exercise to the music. Receives: Other: Low-impact aerobic exercise |
| Control group | Active comparator | With this group no intervention is done, but they are assessed like the other groups. Receives: Other: Control group |
What is being measured
The primary outcome is the main question the study is designed to answer.
General discomfort.
General discomfort, using the Faces Pain Scale. This scale assesses in a global way widespread pain of patients. It values from 0 to 10 on a scale of facial expression (0 = no pain and smiling face, up to 10 = worst possible pain and sad face). The reliability coefficient for this scale is Cohen = 0.61.
Measured: 8 weeks
Secondary outcomes (3)
Depression.
By Beck Depression Inventory. This scale aims to assess depression and its somatic intensity by 21 different items assessing depressive symptoms. It includes four answer options arranged from lowest to highest severity. This version is adapted to Spanish and validated and has an internal consistency with Cronbach's alpha coefficient = 0.83. The scale emphasizes more on the cognitive component of depression (15 items), being the symptoms of somatic / vegetative type the second most important group (6 items). The result of 0-9 points means that there is no depression, 10 to 18 points mild depression, 19-29 moderate depression and 30 points indicates severe depression.
Measured: 8 weeks
Impact on quality of life.
The Fibromyalgia Impact Questionnaire (FIQ).It is a multidimensional self-administered questionnaire with 10 items that evaluates the status of the patient the week before the test is filled, and it assesses the aspects that tend to be more affected in people with fibromyalgia. The first item contains 10 sub-items, ranging from 4 points (from = always to 3 = never) and assesses the patient's functional capacity in activities of daily living. The second and third item refers to days of the week and the rest are visual analog scales from 0 to 10. This scale was validated in its Spanish version in 2013, obtaining a Cronbach coefficient= 0.95.
Measured: 8 weeks
Balance.
Evaluated by the Berg Scale. Scale on which the balance is evaluated and consists of 14 items, which assess the change of position from sitting to standing position, as well as standing and sitting position without assistance, transfers, standing with eyes closed, feet together, one foot advanced, one leg support, inclination of the body, the ability to pick up an object from the floor and also to turn around (to look back only, or giving a full turn). The internal consistency of the questionnaire is alpha 0.98 and test-retest reliability of 0.98 with a range of 0.86 to 0.99 for individual items.
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 posted6 Aug 2015 (estimated)
- Study startJul 2015
- Primary completionJan 2016
- Study completionMar 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for FibromyalgiaStudies of the same condition, open and under way.
- More trials run by University of ValenciaThe sponsor's other registered studies.
- 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
- Factorial
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 26 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Valencia
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, GEMMA V ESPÍ LÓPEZ, PhD, University of Valencia
- Investigators
- Gemma V gemma.espi@uv.es, P, Study director, Department of Physiotherapy
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02516761
- Sponsor's protocol ID
- ID011
- Acronym
- EffMusFibro
- Status last verified
- Mar 2016
- First submitted
- 4 Aug 2015
- Last updated
- 24 Mar 2016
- Results posted
- No
- Data monitoring committee
- No
Publications
Wolfe F, Walitt BT, Rasker JJ, Katz RS, Hauser W. The Use of Polysymptomatic Distress Categories in the Evaluation of Fibromyalgia (FM) and FM Severity. J Rheumatol. 2015 Aug;42(8):1494-501. doi: 10.3899/jrheum.141519. Epub 2015 Jun 15.
PubMed 26077414Kajantie E, Phillips DI. The effects of sex and hormonal status on the physiological response to acute psychosocial stress. Psychoneuroendocrinology. 2006 Feb;31(2):151-78. doi: 10.1016/j.psyneuen.2005.07.002. Epub 2005 Sep 1.
PubMed 16139959de Miquel CA, Campayo J, Florez MT, Arguelles JM, Tarrio EB, Montoya MG, Martin A, Salio AM, Fuentes JV, Alberch EA, de la Camara AG. Interdisciplinary consensus document for the treatment of fibromyalgia. Actas Esp Psiquiatr. 2010 Mar-Apr;38(2):108-20.
PubMed 21361054
Study at a glance
From the registry record, last updated by the sponsor on 24 Mar 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Low-impact Aerobic Exercise Combined With Music Therapy in Patients With Fibromyalgia
- ClinicalTrials.gov ID
- NCT02516761
- Acronym / sponsor ID
- EffMusFibro / ID011
- Conditions
- Fibromyalgia
- Keywords
- Fibromyalgia
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 26 participants (actual)
- Lead sponsor
- University of ValenciaUniversity, hospital or other
- Study start
- Jul 2015
- Primary completion
- Jan 2016 (actual)
- Study completion
- Mar 2016 (actual)
- First posted
- 6 Aug 2015 (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 idea of this study is the combination of these two techniques (low-impact aerobic exercise through functional movements and music therapy) that have proven to be effective separately. The main objective of this study is to test this combination to reduce widespread pain in fibromyalgia patients, improve their balance, influence on decreasing levels of depression and improve quality of life.
Detailed description
Material and methods Patients The sample includes volunteer subjects diagnosed with fibromyalgia from the Valencian Association of People Affected by Fibromyalgia that were submitted to participate in the study.
Study design It is a quasi-experimental, longitudinal, prospective, controlled, randomized, single-blinded research. The sample was divided into 3 groups. Patients signed informed consent and then the randomization of subjects to the different study groups was done through computer software by an external assistant who was blinded to the study objectives. The study was conducted in morning and afternoon sessions.
All those patients who belong to the experimental group 1 or 2 attend their sessions which last 60 minutes and are held 2 times a week every other day. The experimental group 1 attends classes in the morning, while the experimental group 2 attends them in the evenings. The control group only comes to the evaluation sessions without doing any particular activity. The subjects are evaluated in two stages, at baseline and after completion of the study.
Intervention Group 1 (G1): Low-impact aerobic exercise combined with music therapy. Intervention consists in working the muscles which are mostly affected by fibromyalgia through group exercises, which are dynamic, smooth and aim functionality.
Group 2 (G2): Low-impact aerobic exercise. Then intervention is like the previous group but with the difference that physical activity is not performed to the rhythm of chosen melodic music. Therefore, exercises are done with general chill-out music throughout the session, without adaptation of the exercise to the music.
Control group (CG): With this group no intervention is done, but they are assessed like the other groups.
Evaluation:
Depression, by Beck Depression Inventory, General discomfort, using the Faces Pain Scale, Balance, evaluated by the Berg Scale.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Low-impact aerobic exercise combined with music therapy | Experimental | Other: Low-impact aerobic exercise combined with music therapyIntervention consists in working the muscles which are mostly affected by fibromyalgia through group exercises, which are dynamic, smooth and aim functionality. This exercise is done to the rhythm of melodic music, adapted to the tastes of the participants and also adapted on the way to perform the exercise. |
| Low-impact aerobic exercise | Experimental | Other: Low-impact aerobic exerciseThen intervention is like the previous group but with the difference that physical activity is not performed to the rhythm of chosen melodic music. Therefore, exercises are done with general chill-out music throughout the session, without adaptation of the exercise to the music. |
| Control group | Active comparator | Other: Control groupWith this group no intervention is done, but they are assessed like the other groups. |
Who may qualify
- Ages
- 30 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- To be between 30 and 80 years old.
- Meet the new diagnostic criteria for fibromyalgia of the ACR..
- Meet some or several of the following characteristics:
- May have limited mobility as long as it is caused by fibromyalgia.
Key exclusion criteria (7 listed)
- Medical contraindication for physical activity (locomotor disorder, uncontrolled cardiovascular disease, ...)
- Deafness or limited hearing
- Vestibular disorders that compromise balance.
- Very low visibility or blind people.
- Psychiatric disorders or excessive emotional tension that could alter the dynamics of the study (psychotic disorder)
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 |
|---|---|---|
| Low-impact aerobic exercise combined with music therapyIntervention consists in working the muscles which are mostly affected by fibromyalgia through group exercises, which are dynamic, smooth and aim functionality. Each session consists of 60 minutes with 3 parts: initial warming up time, main part through games, group dynamics and pure aerobic workout, and final cool down with stretching. This exercise is done to the rhythm of melodic music, adapted to the tastes of the participants and also adapted on the way to perform the exercise. For this, they were shown a list of 100 music compositions from which participants choose a minimum of 20 preferences. All exercises are performed with proper postural control both dissociated and global and within a framework of therapeutic proprioceptive gymnastics. | Other | Low-impact aerobic exercise combined with music therapy |
| Low-impact aerobic exerciseLow-impact aerobic exercise. Then intervention is like the previous group but with the difference that physical activity is not performed to the rhythm of chosen melodic music. Therefore, exercises are done with general chill-out music throughout the session, without adaptation of the exercise to the music. | Other | Low-impact aerobic exercise |
| Control groupWith this group no intervention is done, but they are assessed like the other groups. | Other | Control group |
Primary outcome
General discomfort.
Time frame: 8 weeks
General discomfort, using the Faces Pain Scale. This scale assesses in a global way widespread pain of patients. It values from 0 to 10 on a scale of facial expression (0 = no pain and smiling face, up to 10 = worst possible pain and sad face). The reliability coefficient for this scale is Cohen = 0.61.
3 secondary outcomes
Depression.
Time frame: 8 weeks
Impact on quality of life.
Time frame: 8 weeks
Balance.
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 24 Mar 2016.
- Results publication: PubMed 26077414Wolfe F, Walitt BT, Rasker JJ, Katz RS, Hauser W. The Use of Polysymptomatic Distress Categories in the Evaluation of Fibromyalgia (FM) and FM Severity. J Rheumatol. 2015 Aug;42(8):1494-501. doi: 10.3899/jrheum.141519. Epub 2015 Jun 15.
- Results publication: PubMed 16139959Kajantie E, Phillips DI. The effects of sex and hormonal status on the physiological response to acute psychosocial stress. Psychoneuroendocrinology. 2006 Feb;31(2):151-78. doi: 10.1016/j.psyneuen.2005.07.002. Epub 2005 Sep 1.
- Results publication: PubMed 21361054de Miquel CA, Campayo J, Florez MT, Arguelles JM, Tarrio EB, Montoya MG, Martin A, Salio AM, Fuentes JV, Alberch EA, de la Camara AG. Interdisciplinary consensus document for the treatment of fibromyalgia. Actas Esp Psiquiatr. 2010 Mar-Apr;38(2):108-20.
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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.
Gemma V gemma.espi@uv.es, P study director
Department of Physiotherapy
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Low-impact aerobic exercise combined with music therapy and Low-impact aerobic exercise in people with Fibromyalgia, run by University of Valencia 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 9 inclusion and 7 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 24 Mar 2016. 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?
General discomfort. (time frame: 8 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 NCT02516761, which also lists 3 linked publications.
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 24 Mar 2016.