FibromyalgiaPhase 1ESTFNCT01547195
Effects of Swimming in the Treatment of Fibromyalgia
A Phase 1 study testing swim training and Training walk in people with Fibromyalgia, run by Federal University of São Paulo at 2 sites in Brazil.
Trial summary
The recent scientific evidence shows that FM patients improve exercise capacity, symptoms and quality of life with the holding of regular exercise, especially aerobic exercise. Swimming is an aerobic workout of low impact, but no study has evaluated the effect of this activity in patients with fibromyalgia. Read more about this study
- Who is it for?
- Ages 18 to 60 years, women only
- Conditions the study is for
- Fibromyalgia
- What is being tested?
- swim training and Training walk
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 75 participants
- Where
- 2 sitesBrazil
- Study dates
- Jan 2012to Dec 2012
- Phase
- Phase 1
- 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 according to the classification criteria of the American College of Rheumatology;
- Patients with degree of pain between 4 and 8 cm by VAS-visual analog scale;
- Patients who can swim the freestyle "(crawl)"; Patients with stable-medication for at least three months;
- All patients will have signing the consent form.
Who cannot join
- Patients with uncontrolled cardiac disease and / or unable to perform aerobic exercises;
- Patients with severe psychiatric disorders;
- Patients with uncontrolled diabetes mellitus;
- Patients who practice regular physical exercise for at least 3 months;
- Patients with skin diseases that contraindicate the use of swimming pool;
- Patients with inflammatory rheumatic diseases.
Trial locations and contacts
2 sites in 1 country.
Brazil2 sites, 2 recruiting
- Recruiting
Ambulatory at UNIFESP
São Paulo, São Paulo
Giovana Fernandes, Master, +55 11 84987581, gifernandespersonal@hotmail.com
Giovana Fernandes, Mestranda
- Recruiting
Universidade Federal de São Paulo
São Paulo, São Paulo
Jamil Natour, Professor, +55 11 55764239, jnatour@unifesp.com.br
Giovana Fernandes, Mestranda, +55 11 25943375
About this study
Official title: Assessment of the Effects of Swimming in the Treatment of Patients With Fibromyalgia.
The recent scientific evidence shows that FM patients improve exercise capacity, symptoms and quality of life with the holding of regular exercise, especially aerobic exercise. Swimming is an aerobic workout of low impact, but no study has evaluated the effect of this activity in patients with fibromyalgia.
Randomized controlled trial with blinded evaluator, which will be evaluated patients with fibromyalgia were divided into two groups.
The intervention group will hold an exercise program of swimming (freestyle) and the other considered the control group held a walking program.
Read the detailed description
Fibromyalgia (FM) is a syndrome characterized by diffuse musculoskeletal pain and chronic, with points called "hot spots", specific, sensitive and painful on palpation. Objective: To evaluate the efficacy of swimming in reducing the generally pain and improve the quality of function, of life and exercise capacity in patients with fibromyalgia. Material and Methods: 82 patients will be screened, diagnosed with fibromyalgia, who can swim the front crawl. Will be selected at UNIFESP outpatient clinics and also through advertisement in a newspaper. One group held the swimming training and the other group (control) will walk training. The Participants perform exercises (swimming or running) three times a week for 50 minutes, for 12 weeks. The exercises will be held at the anaerobic threshold determined by cardiopulmonary exercise testing. Measuring instrument: Questionnaires VAS (visual analogue scale) for pain, FIQ (Fibromyalgia Impact Questionnaire) to assess the quality of life related to disease, and also the SF-36 (short form health survey), which assesses quality of life in general. Cardiopulmonary stress test to assess cardiorespiratory fitness to sit and stand up and test to assess functional capacity. All participants will conduct an initial evaluation, after 6 and 13 weeks of training.
- Conditions
- Fibromyalgia
- Being tested
- swim training, Training walk
- Keywords
- fibromyalgia, swimming
- Medical subject headings
- Fibromyalgia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
swim trainingProcedure or surgery
Also called Swimming., Freestyle.
Swimming training will be conducted with the implementation of the freestyle. The training will be held a week with 3 X 50 minutes for a period of 12 weeks.
Patients will be monitored by a frequency waterproof. When at the beginning of training are carried out five minutes of heating, followed by 40minutos swimming 5 minutes and cooling at the end of training.
Training walkProcedure or surgery
Also called Walk.
The control group will perform walking exercise outdoors, monitored by a frequency, with the heart rate at anaerobic threshold assessed by cardiopulmonary exercise test.
The training of walking will last 50 minutes, three times per week for 12 weeks.
At the beginning of training, there will be a heating time of 5 minutes, followed by LA walk in cooling for 40 minutes and 5 minutes.
| Study group | Role | What they receive |
|---|---|---|
| Group-swimming | Experimental | Not described Receives: Procedure: swim training |
| Control-walk | Active comparator | Not described Receives: Procedure: Training walk |
What is being measured
The primary outcome is the main question the study is designed to answer.
Diminishing of pain
_ Assess the effectiveness of the practice of swimming in reducing pain and improving quality of life in patients with FM.
Measured: 3 months
Secondary outcomes (1)
Improving quality of life
_ Assess the effectiveness of the practice of swimming in improved function and aerobic capacity in patients with FM.
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Mar 2012 (estimated)
- Study startJan 2012
- Primary completionJan 2012
- Study completionDec 2012 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 75 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Federal University of São Paulo
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Giovana Fernandes, Federal University of São Paulo
- Investigators
- Giovana Fernandes, Mestranda, Principal investigator, Universidade Federal de São Paulo
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01547195
- Sponsor's protocol ID
- 0360/10
- Acronym
- ESTF
- Status last verified
- Mar 2012
- First submitted
- 21 Feb 2012
- Last updated
- 30 Mar 2012
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Fernandes G, Jennings F, Nery Cabral MV, Pirozzi Buosi AL, Natour J. Swimming Improves Pain and Functional Capacity of Patients With Fibromyalgia: A Randomized Controlled Trial. Arch Phys Med Rehabil. 2016 Aug;97(8):1269-75. doi: 10.1016/j.apmr.2016.01.026. Epub 2016 Feb 20.
PubMed 26903145
Study at a glance
From the registry record, last updated by the sponsor on 30 Mar 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessment of the Effects of Swimming in the Treatment of Patients With Fibromyalgia.
- ClinicalTrials.gov ID
- NCT01547195
- Acronym / sponsor ID
- ESTF / 0360/10
- Conditions
- Fibromyalgia
- Keywords
- fibromyalgia, swimming
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 75 participants (estimated)
- Lead sponsor
- Federal University of São PauloUniversity, hospital or other
- Study start
- Jan 2012
- Primary completion
- Jan 2012 (actual)
- Study completion
- Dec 2012 (estimated)
- First posted
- 7 Mar 2012 (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 recent scientific evidence shows that FM patients improve exercise capacity, symptoms and quality of life with the holding of regular exercise, especially aerobic exercise. Swimming is an aerobic workout of low impact, but no study has evaluated the effect of this activity in patients with fibromyalgia.
Randomized controlled trial with blinded evaluator, which will be evaluated patients with fibromyalgia were divided into two groups.
The intervention group will hold an exercise program of swimming (freestyle) and the other considered the control group held a walking program.
Detailed description
Fibromyalgia (FM) is a syndrome characterized by diffuse musculoskeletal pain and chronic, with points called "hot spots", specific, sensitive and painful on palpation. Objective: To evaluate the efficacy of swimming in reducing the generally pain and improve the quality of function, of life and exercise capacity in patients with fibromyalgia. Material and Methods: 82 patients will be screened, diagnosed with fibromyalgia, who can swim the front crawl. Will be selected at UNIFESP outpatient clinics and also through advertisement in a newspaper. One group held the swimming training and the other group (control) will walk training. The Participants perform exercises (swimming or running) three times a week for 50 minutes, for 12 weeks. The exercises will be held at the anaerobic threshold determined by cardiopulmonary exercise testing. Measuring instrument: Questionnaires VAS (visual analogue scale) for pain, FIQ (Fibromyalgia Impact Questionnaire) to assess the quality of life related to disease, and also the SF-36 (short form health survey), which assesses quality of life in general. Cardiopulmonary stress test to assess cardiorespiratory fitness to sit and stand up and test to assess functional capacity. All participants will conduct an initial evaluation, after 6 and 13 weeks of training.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group-swimming | Experimental | Procedure: swim training |
| Control-walk | Active comparator | Procedure: Training walk |
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 according to the classification criteria of the American College of Rheumatology;
- Patients with degree of pain between 4 and 8 cm by VAS-visual analog scale;
- Patients who can swim the freestyle "(crawl)"; Patients with stable-medication for at least three months;
- All patients will have signing the consent form.
Key exclusion criteria (6 listed)
- Patients with uncontrolled cardiac disease and / or unable to perform aerobic exercises;
- Patients with severe psychiatric disorders;
- Patients with uncontrolled diabetes mellitus;
- Patients who practice regular physical exercise for at least 3 months;
- Patients with skin diseases that contraindicate the use of swimming pool;
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 |
|---|---|---|
| swim trainingAlso: Swimming., Freestyle.Swimming training will be conducted with the implementation of the freestyle. The training will be held a week with 3 X 50 minutes for a period of 12 weeks. Patients will be monitored by a frequency waterproof. When at the beginning of training are carried out five minutes of heating, followed by 40minutos swimming 5 minutes and cooling at the end of training. | Procedure or surgery | Group-swimming |
| Training walkAlso: Walk.The control group will perform walking exercise outdoors, monitored by a frequency, with the heart rate at anaerobic threshold assessed by cardiopulmonary exercise test. The training of walking will last 50 minutes, three times per week for 12 weeks. At the beginning of training, there will be a heating time of 5 minutes, followed by LA walk in cooling for 40 minutes and 5 minutes. | Procedure or surgery | Control-walk |
Primary outcome
Diminishing of pain
Time frame: 3 months
_ Assess the effectiveness of the practice of swimming in reducing pain and improving quality of life in patients with FM.
1 secondary outcome
Improving quality of life
Time frame: 3 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Mar 2012.
- Derived from this study: PubMed 26903145Fernandes G, Jennings F, Nery Cabral MV, Pirozzi Buosi AL, Natour J. Swimming Improves Pain and Functional Capacity of Patients With Fibromyalgia: A Randomized Controlled Trial. Arch Phys Med Rehabil. 2016 Aug;97(8):1269-75. doi: 10.1016/j.apmr.2016.01.026. Epub 2016 Feb 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.
Giovana Fernandes, Mestranda principal investigator
Universidade Federal de São Paulo
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing swim training and Training walk in people with Fibromyalgia, run by Federal University of São Paulo at 2 sites 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 6 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 30 Mar 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Contact Giovana Fernandes, Mestranda (+55 11 25943375, gifernandespersonal@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Diminishing of pain (time frame: 3 months). 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 NCT01547195, 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 30 Mar 2012.