Fibromyalgia, PrimaryNCT03149198
Mat Pilates Method in the Treatment of Women With Fibromyalgia
A study testing Mat Pilates exercises and Aquatic aerobic exercises in people with Fibromyalgia, Primary, run by Universidade Federal do Rio Grande do Norte at 1 site in Brazil.
Trial summary
Introduction: Physical exercises have been recommended to improve overall well-being in patients with fibromyalgia, with the main goal of repairing the effects of lack of physical conditioning, and improving symptoms especially pain and fatigue. Read more about this study
- Who is it for?
- Ages 18 to 60 years, women only
- Conditions the study is for
- Fibromyalgia, Primary
- What is being tested?
- Mat Pilates exercises and Aquatic aerobic exercises
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 42 participants
- Where
- 1 siteBrazil
- Study dates
- 4 Sep 2017to 1 Aug 2018
- 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 60 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- Female patients with fibromyalgia diagnosed according to the classification criteria of the American College of Rheumatology,
- aged 18 to 60 years,
- with VAS between 3 and 8,
- who signed the free and informed consent term.
Who cannot join
- Patients with uncontrolled hypertension;
- Decompensated cardiorespiratory disease;
- History of syncopes or arrhythmias induced by physical exercise;
- Diabetes unbalanced;
- Psychiatric disorders;
- History of regular physical exercise (at least 2 times a week) in the last 6 months
- any other condition that makes it impossible for a patient to perform physical exercises.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Assessment of the Effectiveness of the Mat Pilates Method in the Treatment of Women With Fibromyalgia in the Santa Cruz City, Rio Grande do Norte, Brazil: A Randomized Controlled Trial
Introduction: Physical exercises have been recommended to improve overall well-being in patients with fibromyalgia, with the main goal of repairing the effects of lack of physical conditioning, and improving symptoms especially pain and fatigue. Very well estimated and widely known are the studies that support the use of the pilates method as effective in improving the symptoms of the disease.
Objective: To evaluate the effectiveness of the soil method in improving pain in women with fibromyalgia in the city of Santa Cruz, RN.
Read more
Methodology: This is a randomized controlled trial with blind evaluator, where 60 patients with fibromyalgia diagnosis are divided into two groups. The intervention group, perform an exercise program based on the pilates method in soil and another, considered control group, participate in a program of aerobic exercises in the pool. Both groups conduct supervised exercise programs 2 times a week for a period of 12 weeks. The evaluation instruments used in an EVA (visual pain scale); FIQ Questionnaire - Fibromyalgia Impact Questionnaire; Functional ability by the "Timed Up and Go" test and 6-minute walk test; A quality of sleep by the Pittsburgh Sleep Quality Index (PSQI-BR) and an ESS-BR (Epworth Sleepiness Scale); Finally, a general quality of life for the SF-36.
Statistical analysis: Data are analyzed by t-student, Mann-Whitney test, repeated-measures ANOVA and intention-to-treat analysis.
- Conditions
- Fibromyalgia, Primary
- Being tested
- Mat Pilates exercises, Aquatic aerobic exercises
- Keywords
- Fibromyalgia, pilates, exercises
- 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.
Mat Pilates exercisesOther
The exercise program based on the pilates method will be performed on the ground in the group room of the FACISA / UFRN Physiotherapy School Clinic in Santa Cruz. The room has ample space and air conditioning for better patient accommodation. The exercises will be performed twice a week for 12 weeks. Each session will last about 50 minutes and will be supervised by a physical therapy student along with the research coordinator. A total of 10 exercises will be performed.
Aquatic aerobic exercisesOther
The aerobic exercise program will be held in the therapeutic pool of the Physiotherapy School Clinic of FACISA / UFRN in Santa Cruz. The pool is heated and provides better effects to the proposed treatment.
The exercises will be performed twice a week for 12 weeks. Each session will last about 50 minutes and will be supervised by another physical therapy student along with the research coordinator.
| Study group | Role | What they receive |
|---|---|---|
| Interventional group | Experimental | Mat pilates exercises Receives: Other: Mat Pilates exercises |
| Control group | Active comparator | Aquatic aerobic exercises Receives: Other: Aquatic aerobic exercises |
What is being measured
The primary outcome is the main question the study is designed to answer.
Assessment of Pain
Visual analogic scale (0-10)
Measured: baseline
Assessment of Pain
Visual analogic scale (0-10)
Measured: 12 week
Secondary outcomes (6)
Assessment of Function
Fibromyalgia Impact Questionnaire
Measured: baseline
Assessment of Function
Fibromyalgia Impact Questionnaire
Measured: 12 Week
Assessment of Quality of life
SF-36 Questionnaire
Measured: baseline
Assessment of Quality of life
SF-36 Questionnaire
Measured: 12 week
Assessment of Physical Function
Timed Up and Go test - This is a performance functional test
Measured: baseline
Assessment of Physical Function
Timed Up and Go test- This is a performance functional test
Measured: 12 week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 May 2017
- Study start4 Sep 2017
- Primary completion7 Dec 2017
- Study completion1 Aug 2018
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 Fibromyalgia, PrimaryStudies 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
- 42 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universidade Federal do Rio Grande do Norte
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Marcelo Cardoso de Souza, Universidade Federal do Rio Grande do Norte
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03149198
- Sponsor's protocol ID
- CAAE0000
- Status last verified
- Aug 2018
- First submitted
- 20 Apr 2017
- Last updated
- 17 Aug 2018
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: There is not a plan to make individual participant data (IPD) available to other researchers.
Publications
de Medeiros SA, de Almeida Silva HJ, do Nascimento RM, da Silva Maia JB, de Almeida Lins CA, de Souza MC. Mat Pilates is as effective as aquatic aerobic exercise in treating women with fibromyalgia: a clinical, randomized and blind trial. Adv Rheumatol. 2020 Apr 6;60(1):21. doi: 10.1186/s42358-020-0124-2.
PubMed 32252822Silva HJA, Lins CAA, Nobre TTX, de Sousa VPS, Caldas RTJ, de Souza MC. Mat Pilates and aquatic aerobic exercises for women with fibromyalgia: a protocol for a randomised controlled blind study. BMJ Open. 2019 Feb 19;9(2):e022306. doi: 10.1136/bmjopen-2018-022306.
PubMed 30782866
Study at a glance
From the registry record, last updated by the sponsor on 17 Aug 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessment of the Effectiveness of the Mat Pilates Method in the Treatment of Women With Fibromyalgia in the Santa Cruz City, Rio Grande do Norte, Brazil: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT03149198
- Acronym / sponsor ID
- CAAE0000
- Conditions
- Fibromyalgia, Primary
- Keywords
- Fibromyalgia, pilates, exercises
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 42 participants (actual)
- Lead sponsor
- Universidade Federal do Rio Grande do NorteUniversity, hospital or other
- Study start
- 4 Sep 2017 (actual)
- Primary completion
- 7 Dec 2017 (actual)
- Study completion
- 1 Aug 2018 (actual)
- First posted
- 11 May 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.
Introduction: Physical exercises have been recommended to improve overall well-being in patients with fibromyalgia, with the main goal of repairing the effects of lack of physical conditioning, and improving symptoms especially pain and fatigue. Very well estimated and widely known are the studies that support the use of the pilates method as effective in improving the symptoms of the disease.
Objective: To evaluate the effectiveness of the soil method in improving pain in women with fibromyalgia in the city of Santa Cruz, RN.
Methodology: This is a randomized controlled trial with blind evaluator, where 60 patients with fibromyalgia diagnosis are divided into two groups. The intervention group, perform an exercise program based on the pilates method in soil and another, considered control group, participate in a program of aerobic exercises in the pool. Both groups conduct supervised exercise programs 2 times a week for a period of 12 weeks. The evaluation instruments used in an EVA (visual pain scale); FIQ Questionnaire - Fibromyalgia Impact Questionnaire; Functional ability by the "Timed Up and Go" test and 6-minute walk test; A quality of sleep by the Pittsburgh Sleep Quality Index (PSQI-BR) and an ESS-BR (Epworth Sleepiness Scale); Finally, a general quality of life for the SF-36.
Statistical analysis: Data are analyzed by t-student, Mann-Whitney test, repeated-measures ANOVA and intention-to-treat analysis.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Interventional group | Experimental | Other: Mat Pilates exercisesMat pilates exercises |
| Control group | Active comparator | Other: Aquatic aerobic exercisesAquatic aerobic exercises |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Female patients with fibromyalgia diagnosed according to the classification criteria of the American College of Rheumatology,
- aged 18 to 60 years,
- with VAS between 3 and 8,
- who signed the free and informed consent term.
Key exclusion criteria (7 listed)
- Patients with uncontrolled hypertension;
- Decompensated cardiorespiratory disease;
- History of syncopes or arrhythmias induced by physical exercise;
- Diabetes unbalanced;
- Psychiatric disorders;
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 |
|---|---|---|
| Mat Pilates exercisesThe exercise program based on the pilates method will be performed on the ground in the group room of the FACISA / UFRN Physiotherapy School Clinic in Santa Cruz. The room has ample space and air conditioning for better patient accommodation. The exercises will be performed twice a week for 12 weeks. Each session will last about 50 minutes and will be supervised by a physical therapy student along with the research coordinator. A total of 10 exercises will be performed. | Other | Interventional group |
| Aquatic aerobic exercisesThe aerobic exercise program will be held in the therapeutic pool of the Physiotherapy School Clinic of FACISA / UFRN in Santa Cruz. The pool is heated and provides better effects to the proposed treatment. The exercises will be performed twice a week for 12 weeks. Each session will last about 50 minutes and will be supervised by another physical therapy student along with the research coordinator. | Other | Control group |
Primary outcome
Assessment of Pain
Time frame: baseline
Visual analogic scale (0-10)
Assessment of Pain
Time frame: 12 week
Visual analogic scale (0-10)
6 secondary outcomes
Assessment of Function
Time frame: baseline
Assessment of Function
Time frame: 12 Week
Assessment of Quality of life
Time frame: baseline
Assessment of Quality of life
Time frame: 12 week
Assessment of Physical Function
Time frame: baseline
Assessment of Physical Function
Time frame: 12 week
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 17 Aug 2018.
- Derived from this study: PubMed 32252822de Medeiros SA, de Almeida Silva HJ, do Nascimento RM, da Silva Maia JB, de Almeida Lins CA, de Souza MC. Mat Pilates is as effective as aquatic aerobic exercise in treating women with fibromyalgia: a clinical, randomized and blind trial. Adv Rheumatol. 2020 Apr 6;60(1):21. doi: 10.1186/s42358-020-0124-2.
- Derived from this study: PubMed 30782866Silva HJA, Lins CAA, Nobre TTX, de Sousa VPS, Caldas RTJ, de Souza MC. Mat Pilates and aquatic aerobic exercises for women with fibromyalgia: a protocol for a randomised controlled blind study. BMJ Open. 2019 Feb 19;9(2):e022306. doi: 10.1136/bmjopen-2018-022306.
- Individual participant dataSharing planned: No. There is not a plan to make individual participant data (IPD) available to other researchers.
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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 Mat Pilates exercises and Aquatic aerobic exercises in people with Fibromyalgia, Primary, run by Universidade Federal do Rio Grande do Norte 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 4 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 17 Aug 2018. 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?
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?
Assessment of Pain (time frame: baseline). The study lists 2 primary outcomes in all. 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 NCT03149198, 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 17 Aug 2018.