FibromyalgiaNCT03050606
Effectiveness and Cost-effectiveness of Modified Pilates Method Versus Aerobic Exercise in Patients With Fibromyalgia
A study testing Pilates and Aerobic in people with Fibromyalgia, run by Universidade Cidade de Sao Paulo at 1 site in Brazil.
Trial summary
Fibromyalgia is a rheumatologic disease characterized by generalized chronic pain, hyperalgesia and allodynia. Physical exercises are recommended as the first choice of non-pharmacological therapy. Read more about this study
- Who is it for?
- Ages 20 to 75 years
- Conditions the study is for
- Fibromyalgia
- What is being tested?
- Pilates and Aerobic
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 98 participants
- Where
- 1 siteBrazil
- Study dates
- 15 Feb 2017to 22 Dec 2020
- 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 20 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients that meet the criteria for classification of fibromyalgia according to the criteria of the American College of Rheumatology 2010; and
- Pain intensity greater than or equal to 3 points in the Pain Numerical Rating Scale
Who cannot join
- Contraindications to physical exercise
- Pregnancy
- Uncontrolled systemic diseases (diabetes mellitus, systemic arterial hypertension and thyroid dysfunctions);
- Neurological, cardiorespiratory and musculoskeletal conditions that interfere with treatment such as: paralysis, significant changes in sensitivity, changes in level of consciousness and understanding, advanced joint diseases (severe arthrosis, hip or knee arthroplasty, severe rheumatoid arthritis), cervicalgia with irradiation to the upper limbs, among others;
- Injury or severe pain in the lower limbs that limit the performance of aerobic exercises: meniscus injury, plantar fasciitis, among others;
- Partial or total muscular ruptures;
Show all 9Show fewer
- Amputations;
- Recent postoperative; and
- Inability to understand the writing and speaking of the Portuguese language.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effectiveness and Cost-effectiveness of Modified Pilates Method Versus Aerobic Exercise in the Treatment of Patients With Fibromyalgia: a Randomized Controlled Trial
Fibromyalgia is a rheumatologic disease characterized by generalized chronic pain, hyperalgesia and allodynia. Physical exercises are recommended as the first choice of non-pharmacological therapy. Thus, the purpose of this study is to evaluate the effectiveness and cost-effectiveness of modified Pilates method exercises compared to aerobic exercises in the treatment of patients with fibromyalgia. The hypothesis is that Pilates exercises will be as effective as aerobic exercise in the improvement of clinical outcomes, and that this improvement will be maintained over the medium to long term. It is also expected that aerobic exercises will be more cost-effective.
Read the detailed description
Fibromyalgia is a rheumatologic disease characterized by generalized chronic pain, hyperalgesia and allodynia. Physical exercises are recommended as the first choice of non-pharmacological therapy. Thus, the purpose of this study is to evaluate the effectiveness and cost-effectiveness of modified Pilates method exercises compared to aerobic exercise in the treatment of patients with fibromyalgia. For this, the following outcomes of 98 patients will be evaluated by a blinded evaluator at baseline, 8 weeks, 6 and 12 months after randomization: fibromyalgia impact assessed by the Fibromyalgia Impact Questionnaire, pain intensity assessed by the Pain Numerical Rating Scale, kinesiophobia assessed by the Tampa Scale for Kinesiophobia, specific disability assessed by the Patient-Specific Functional Scale, functional capacity assessed by the 6-minute Walk Test, quality of sleep assessed by the Pittsburgh Sleep Quality Index, and health-related quality of life assessed by the EQ-5D-3L and SF-6D questionnaires. Participants will be randomly divided into Aerobic Group, who will perform aerobic exercises on treadmills and/or stationary bikes, and Pilates Group, which will perform exercises of the modified Pilates method. Both groups will be treated for eight weeks, twice a week. The hypothesis is that Pilates exercises will be as effective as aerobic exercise in the improvement of clinical outcomes, and that this improvement will be maintained over the medium to long term. It is also expected that aerobic exercises will be more cost-effective.
- Conditions
- Fibromyalgia
- Being tested
- Pilates, Aerobic
- Keywords
- Exercise Therapy, Exercise Movement Techniques, Pilates-Based Exercises, Cost-effectiveness
- Medical subject headings
- Fibromyalgia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PilatesOther
Also called Modified Pilates method exercises
Exercises performed on the mat and apparatus, following the six principles of the Pilates method. The exercises will be performed in three levels of difficulty: basic, intermediate and advanced, according to the capacity of the patient.
AerobicOther
Aerobic exercise will be carried out individually on treadmills or stationary bikes. The intensity of the training will be mild to moderate (57% to 76% of the maximal heart rate monitored by the frequencymeter).
| Study group | Role | What they receive |
|---|---|---|
| Pilates | Experimental | This group will perform a modified Pilates exercise program, which will be performed using mat, accessories and studio apparatus, in individual sessions, twice a week, lasting 60 minutes.
Both groups will also receive an educational booklet with information on fibromyalgia and self-care strategies for pain management, sleep improvement, depression improvement, stress and fatigue control. Receives: Other: Pilates |
| Aerobic | Active comparator | This group will perform aerobic exercise, performed on the treadmill or stationary bike according to the choice of the patient. The training will be performed controlling the heart rate of training. The exercises will be performed individually, twice a week and each session will last 60 minutes.
Both groups will also receive an educational booklet with information on fibromyalgia and self-care strategies for pain management, sleep improvement, depression improvement, stress and fatigue control. Receives: Other: Aerobic |
What is being measured
The primary outcome is the main question the study is designed to answer.
Fibromyalgia impact
This outcome will be evaluated by the Fibromyalgia Impact Questionnaire (FIQ) which is composed of 10 items. Item 1 contains 10 questions related to functionality, each of these issues being evaluated by a 4-point Likert scale, which ranges from 0 (always) to 3 (never). In items 2 and 3, the patient scores the number of days that felt well and that was unable to work due to fibromyalgia in the last seven days. Items 4 to 10 are composed of numerical scales that assess difficulty for work, pain, fatigue, morning tiredness, stiffness, anxiety and depression. The FIQ score ranges from 0 to 100 points and the higher values indicate greater fibromyalgia impact on quality of life.
Measured: Eight weeks after randomization
Secondary outcomes (9)
Fibromyalgia impact
This outcome will be evaluated by the Fibromyalgia Impact Questionnaire (FIQ) which is composed of 10 items. Item 1 contains 10 questions related to functionality, each of these issues being evaluated by a 4-point Likert scale, which ranges from 0 (always) to 3 (never). In items 2 and 3, the patient scores the number of days that felt well and that was unable to work due to fibromyalgia in the last seven days. Items 4 to 10 are composed of numerical scales that assess difficulty for work, pain, fatigue, morning tiredness, stiffness, anxiety and depression. The FIQ score ranges from 0 to 100 points and the higher values indicate greater fibromyalgia impact on quality of life.
Measured: Six and twelve months after randomization
Pain intensity
This outcome will be evaluated by an 11-point scale ranging from 0 to 10, in which 0 represents "no pain" and 10 represents "pain as bad as it could be." The participant will classify his average pain in the last 7days.
Measured: Eight weeks, six and twelve months after randomization
Pain intensity
This outcome will be evaluated by an 11-point scale ranging from 0 to 10, in which 0 represents "no pain" and 10 represents "pain as bad as it could be." The participant will classify his average pain before and after each treatment session .
Measured: Eigth weeks, before and after each intervention session
Functional capacity
This outcome will be assessed using the 6-Minute Walk Test. Two cones will be used, which will mark the starting point and 30 meters, where the patient will turn around and continue walking without hesitation. The area of the test will also have markings every 3 meters. The patient should walk for 6 minutes, as fast as he can, without running, while the evaluator will control the time (for 6 minutes) and count how many laps the patient performs (each turn corresponds to 60 meters). When the stopwatch is stopped, the evaluator will say "stop" and mark the point where the patient stopped with a tape. After the test, the evaluator will request that the patient answer to the Borg's range of effort perception. The measurement of the walked distance will be made by the number of laps added to the meters walked until the patient stops.
Measured: Eight weeks after randomization
Kinesiophobia
This outcome will be evaluated by a 17-item questionnaire. The score of each question varies from 1 ("strongly disagree") to 4 ("strongly agree") points. For the total score, the scores of the questions 4, 8, 12, and 16 should be inverted. The final score can vary from 17 to 68 points, and the higher the score, the greater the degree of kinesiophobia.
Measured: Eight weeks, six and twelve months after randomization
Quality of sleep
This outcome will be evaluated by the Pittsburgh Sleep Quality Index, where the patient will report sleep quality in the last month. The questionnaire consists of 19 self-evaluation questions. The 19 questions are classified into seven components (subjective sleep quality, sleep latency, sleep duration, habitual sleep efficiency, sleep disturbances, sleeping medication use and daytime dysfunction), which are rated at a score ranging from 0 to 3 (0 = none in the last month, 1 = less than 1 time/week, 2 = 1 or 2 times/week, 3 = 3 or more times/week). The sum of the scores for these 7 components ranges from 0 to 21, where the highest score indicates poorer sleep quality.
Measured: Eight weeks, six and twelve months after randomization
Specific disability
This outcome will be evaluated using the Patient-Specific Functional Scale. The participants will identify 3 significant activities that are difficult or that are unable to perform because of fibromyalgia. Next, the participants will rate how able they feel to perform these activities on an 11-point scale (0 to 10), with 0 representing "unable to perform activity" and 10 "able to perform the activity at preinjury level." The final score is the mean of the 3 ratings, and the higher the score, the greater the specific ability.
Measured: Eight weeks, six and twelve months after randomization
Health-related quality of life using the EQ-5D-3L
This outcome will be evaluated by the Euroqol 5 dimensions (EQ-5D-3L). The EQ-5D-3L questionnaire is a generic measure that assesses health-related quality of life through five dimensions, and each dimension with three levels. Health states are labeled with a five-digit numeric code that represents the severity level in each dimension.
Measured: Eight weeks, six and twelve months after randomization
Health-related quality of life using the SF-6D
This outcome will be evaluated by the Short-Form 6 dimensions (SF-6D). The SF-6D questionnaire also measures health-related quality of life, through six domains: functional capacity, global limitation, social aspects, pain, mental health and vitality. The SF-6D score represents the strength of an individual's preference for a particular health condition, ranging from zero to one, where zero corresponds to the worst health condition and one corresponds to the best health status.
Measured: Eight weeks, six and twelve months after randomization
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Feb 2017
- Study start15 Feb 2017
- Primary completion22 Dec 2018
- Study completion22 Dec 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)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
- 98 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Universidade Cidade de Sao Paulo
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Cristina Maria Nunes Cabral, Universidade Cidade de Sao Paulo
- Investigators
- Cristina MN Cabral, PhD, Principal investigator, Universidade Cidade de São Paulo
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03050606
- Sponsor's protocol ID
- UNICID15
- Status last verified
- Mar 2020
- First submitted
- 3 Feb 2017
- Last updated
- 26 Mar 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Franco KFM, Miyamoto GC, Franco YRDS, Salvador EMES, do Nascimento BCB, Menten LA, Cabral CMN. Is Pilates more effective and cost-effective than aerobic exercise in the treatment of patients with fibromyalgia syndrome? A randomized controlled trial with economic evaluation. Eur J Pain. 2023 Jan;27(1):54-71. doi: 10.1002/ejp.2039. Epub 2022 Sep 23.
PubMed 36097826Franco KFM, Franco YRDS, Salvador EMES, do Nascimento BCB, Miyamoto GC, Cabral CMN. Effectiveness and cost-effectiveness of the modified Pilates method versus aerobic exercise in the treatment of patients with fibromyalgia: protocol for a randomized controlled trial. BMC Rheumatol. 2019 Jan 18;3:2. doi: 10.1186/s41927-018-0051-6. eCollection 2019.
PubMed 30886990
Study at a glance
From the registry record, last updated by the sponsor on 26 Mar 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness and Cost-effectiveness of Modified Pilates Method Versus Aerobic Exercise in the Treatment of Patients With Fibromyalgia: a Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT03050606
- Acronym / sponsor ID
- UNICID15
- Conditions
- Fibromyalgia
- Keywords
- Exercise Therapy, Exercise Movement Techniques, Pilates-Based Exercises, Cost-effectiveness
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 98 participants (estimated)
- Lead sponsor
- Universidade Cidade de Sao PauloUniversity, hospital or other
- Study start
- 15 Feb 2017 (actual)
- Primary completion
- 22 Dec 2018 (actual)
- Study completion
- 22 Dec 2020 (estimated)
- First posted
- 13 Feb 2017 (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.
Fibromyalgia is a rheumatologic disease characterized by generalized chronic pain, hyperalgesia and allodynia. Physical exercises are recommended as the first choice of non-pharmacological therapy. Thus, the purpose of this study is to evaluate the effectiveness and cost-effectiveness of modified Pilates method exercises compared to aerobic exercises in the treatment of patients with fibromyalgia. The hypothesis is that Pilates exercises will be as effective as aerobic exercise in the improvement of clinical outcomes, and that this improvement will be maintained over the medium to long term. It is also expected that aerobic exercises will be more cost-effective.
Detailed description
Fibromyalgia is a rheumatologic disease characterized by generalized chronic pain, hyperalgesia and allodynia. Physical exercises are recommended as the first choice of non-pharmacological therapy. Thus, the purpose of this study is to evaluate the effectiveness and cost-effectiveness of modified Pilates method exercises compared to aerobic exercise in the treatment of patients with fibromyalgia. For this, the following outcomes of 98 patients will be evaluated by a blinded evaluator at baseline, 8 weeks, 6 and 12 months after randomization: fibromyalgia impact assessed by the Fibromyalgia Impact Questionnaire, pain intensity assessed by the Pain Numerical Rating Scale, kinesiophobia assessed by the Tampa Scale for Kinesiophobia, specific disability assessed by the Patient-Specific Functional Scale, functional capacity assessed by the 6-minute Walk Test, quality of sleep assessed by the Pittsburgh Sleep Quality Index, and health-related quality of life assessed by the EQ-5D-3L and SF-6D questionnaires. Participants will be randomly divided into Aerobic Group, who will perform aerobic exercises on treadmills and/or stationary bikes, and Pilates Group, which will perform exercises of the modified Pilates method. Both groups will be treated for eight weeks, twice a week. The hypothesis is that Pilates exercises will be as effective as aerobic exercise in the improvement of clinical outcomes, and that this improvement will be maintained over the medium to long term. It is also expected that aerobic exercises will be more cost-effective.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Pilates | Experimental | Other: PilatesThis group will perform a modified Pilates exercise program, which will be performed using mat, accessories and studio apparatus, in individual sessions, twice a week, lasting 60 minutes. Both groups will also receive an educational booklet with information on fibromyalgia and self-care strategies for pain management, sleep improvement, depression improvement, stress and fatigue control. |
| Aerobic | Active comparator | Other: AerobicThis group will perform aerobic exercise, performed on the treadmill or stationary bike according to the choice of the patient. The training will be performed controlling the heart rate of training. The exercises will be performed individually, twice a week and each session will last 60 minutes. Both groups will also receive an educational booklet with information on fibromyalgia and self-care strategies for pain management, sleep improvement, depression improvement, stress and fatigue control. |
Who may qualify
- Ages
- 20 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Patients that meet the criteria for classification of fibromyalgia according to the criteria of the American College of Rheumatology 2010; and
- Pain intensity greater than or equal to 3 points in the Pain Numerical Rating Scale
Key exclusion criteria (9 listed)
- Contraindications to physical exercise
- Pregnancy
- Uncontrolled systemic diseases (diabetes mellitus, systemic arterial hypertension and thyroid dysfunctions);
- Neurological, cardiorespiratory and musculoskeletal conditions that interfere with treatment such as: paralysis, significant changes in sensitivity, changes in level of consciousness and understanding, advanced joint diseases (severe arthrosis, hip or knee arthroplasty, severe rheumatoid arthritis), cervicalgia with irradiation to the upper limbs, among others;
- Injury or severe pain in the lower limbs that limit the performance of aerobic exercises: meniscus injury, plantar fasciitis, among others;
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 |
|---|---|---|
| PilatesAlso: Modified Pilates method exercisesExercises performed on the mat and apparatus, following the six principles of the Pilates method. The exercises will be performed in three levels of difficulty: basic, intermediate and advanced, according to the capacity of the patient. | Other | Pilates |
| AerobicAerobic exercise will be carried out individually on treadmills or stationary bikes. The intensity of the training will be mild to moderate (57% to 76% of the maximal heart rate monitored by the frequencymeter). | Other | Aerobic |
Primary outcome
Fibromyalgia impact
Time frame: Eight weeks after randomization
This outcome will be evaluated by the Fibromyalgia Impact Questionnaire (FIQ) which is composed of 10 items. Item 1 contains 10 questions related to functionality, each of these issues being evaluated by a 4-point Likert scale, which ranges from 0 (always) to 3 (never). In items 2 and 3, the patient scores the number of days that felt well and that was unable to work due to fibromyalgia in the last seven days. Items 4 to 10 are composed of numerical scales that assess difficulty for work, pain, fatigue, morning tiredness, stiffness, anxiety and depression. The FIQ score ranges from 0 to 100 points and the higher values indicate greater fibromyalgia impact on quality of life.
9 secondary outcomes
Fibromyalgia impact
Time frame: Six and twelve months after randomization
Pain intensity
Time frame: Eight weeks, six and twelve months after randomization
Pain intensity
Time frame: Eigth weeks, before and after each intervention session
Functional capacity
Time frame: Eight weeks after randomization
Kinesiophobia
Time frame: Eight weeks, six and twelve months after randomization
Quality of sleep
Time frame: Eight weeks, six and twelve months after randomization
Specific disability
Time frame: Eight weeks, six and twelve months after randomization
Health-related quality of life using the EQ-5D-3L
Time frame: Eight weeks, six and twelve months after randomization
Health-related quality of life using the SF-6D
Time frame: Eight weeks, six and twelve months after randomization
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Mar 2020.
- Derived from this study: PubMed 36097826Franco KFM, Miyamoto GC, Franco YRDS, Salvador EMES, do Nascimento BCB, Menten LA, Cabral CMN. Is Pilates more effective and cost-effective than aerobic exercise in the treatment of patients with fibromyalgia syndrome? A randomized controlled trial with economic evaluation. Eur J Pain. 2023 Jan;27(1):54-71. doi: 10.1002/ejp.2039. Epub 2022 Sep 23.
- Derived from this study: PubMed 30886990Franco KFM, Franco YRDS, Salvador EMES, do Nascimento BCB, Miyamoto GC, Cabral CMN. Effectiveness and cost-effectiveness of the modified Pilates method versus aerobic exercise in the treatment of patients with fibromyalgia: protocol for a randomized controlled trial. BMC Rheumatol. 2019 Jan 18;3:2. doi: 10.1186/s41927-018-0051-6. eCollection 2019.
- Individual participant dataSharing planned: No
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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.
Cristina MN Cabral, PhD principal investigator
Universidade Cidade de 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 Pilates and Aerobic in people with Fibromyalgia, run by Universidade Cidade de Sao 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 2 inclusion and 9 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: status not confirmed, as of the sponsor's last update on 26 Mar 2020. 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?
Results are not available in the source record.
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?
Fibromyalgia impact (time frame: Eight weeks after randomization). 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 NCT03050606, which also lists 2 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 26 Mar 2020.