FibromyalgiaPhase 4NCT02063750
Strengthening Exercises for Fibromyalgia
A Phase 4 study testing strengthening exercises using a Swiss ball and strengthening exercises in people with Fibromyalgia, run by Federal University of São Paulo at 1 site in Brazil.
Trial summary
Objective: We evaluated the effectiveness of strengthening exercises using the Swiss ball in patients with fibromyalgia (FM). Material and Method: Sixty FM patients were randomized into two groups: an intervention group (IG), in which patients performed muscle strength exercises using the Swiss ball, and a stretching… Read more about this study
- Who is it for?
- Ages 20 to 65 years, women only
- Conditions the study is for
- Fibromyalgia
- What is being tested?
- strengthening exercises using a Swiss ball and strengthening exercises
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteBrazil
- Study dates
- Jan 2011to Oct 2013
- Phase
- Phase 4
- 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 65 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- female with fibromyalgia according to the classification criteria of the American College of Rheumatology;
- aged between 20 and 65 years old.
Who cannot join
- uncontrolled hypertension;
- decompensated cardiac disease;
- history of syncope or exercise-induced arrhythmias and decompensated diabetes;
- severe psychiatric illness;
- history of regular exercise at least twice a week for the last 6 months;
- any other condition that could prevent the patient from performing physical exercises.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effectiveness of Strengthening Exercises Using the Swiss Ball for Patients With Fibromyalgia: a Randomized Controlled Trial
Objective: We evaluated the effectiveness of strengthening exercises using the Swiss ball in patients with fibromyalgia (FM).
Material and Method: Sixty FM patients were randomized into two groups: an intervention group (IG), in which patients performed muscle strength exercises using the Swiss ball, and a stretching group (SG), in which patients performed stretching exercises. All patients participated in 40-minute training sessions three times per week for 12 weeks. The IG performed the following eight strengthening exercises using a Swiss ball: lateral rise, simultaneous biceps curl, squat, two arms triceps extension, abdominal, one arm dumbbell row, reverse crucifix and crucifix. The SG performed exercises targeting the same muscle groups trained in IG. Outcome measures were as follows: visual analogue scale (VAS) for pain, 1 repetition maximum test for muscle strength; fibromyalgia impact questionnaire (FIQ) to evaluate disease impact, and short form health survey (SF-36) to assess quality of life. All participants underwent an evaluation at baseline, at 6 weeks and at 12 weeks of training. The assessor was blind to patient allocation.
- Conditions
- Fibromyalgia
- Being tested
- strengthening exercises using a Swiss ball, strengthening exercises
- Keywords
- Fibromyalgia, Muscle strength exercises, Pain, Quality of life
- Medical subject headings
- Fibromyalgia, Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
strengthening exercises using a Swiss ballOther
This group performed eight muscle strengthening exercises using a Swiss ball of 65 cm diameter and dumbbells with different loads.
Each training session was 40 minutes long and was performed three times a week for 12 weeks. The exercises were performed in three sets of 12 repetitions, with an interval of one to two minutes of recovery between exercises, which alternated between upper limbs, lower limbs and abdomen. The load used was 60 % of one repetition maximum (1RM).
strengthening exercisesOther
The stretching group performed stretching exercises that targeted the same muscles trained in the IG. The participants remained in the stretched position for three sets of 30 s for each exercise. The total session time was 40 minutes.
| Study group | Role | What they receive |
|---|---|---|
| Strengthening group | Experimental | This group perform muscle strengthening exercises using a Swiss ball of 65 cm diameter. Receives: Other: strengthening exercises using a Swiss ball |
| Stretching group | Active comparator | Performed stretching exercises Receives: Other: strengthening exercises |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in Pain - VAS
Measured: Basline, after 6 and 12 weeks
Secondary outcomes (3)
Changes in quality of life - Fibromyalgia Impact Questionnaire (FIQ) questionnaire
Measured: Baseline, after 6 and 12 weeks
Changes in muscle strength using the maximum repetition (1 RM)
Measured: Baseline, after 6 and 12 weeks
Changes in consumption of analgesics
Measured: After 6 and 12 weeks from baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Feb 2014 (estimated)
- Study startJan 2011
- Primary completionMay 2013
- Study completionOct 2013
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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Federal University of São Paulo
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jamil Natour, Federal University of São Paulo
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02063750
- Sponsor's protocol ID
- CEP/UNIFESP - 1785/11
- Status last verified
- Feb 2014
- First submitted
- 12 Feb 2014
- Last updated
- 14 Feb 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Feb 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of Strengthening Exercises Using the Swiss Ball for Patients With Fibromyalgia: a Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT02063750
- Acronym / sponsor ID
- CEP/UNIFESP - 1785/11
- Conditions
- Fibromyalgia
- Keywords
- Fibromyalgia, Muscle strength exercises, Pain, Quality of life
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Federal University of São PauloUniversity, hospital or other
- Study start
- Jan 2011
- Primary completion
- May 2013 (actual)
- Study completion
- Oct 2013 (actual)
- First posted
- 14 Feb 2014 (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.
Objective: We evaluated the effectiveness of strengthening exercises using the Swiss ball in patients with fibromyalgia (FM).
Material and Method: Sixty FM patients were randomized into two groups: an intervention group (IG), in which patients performed muscle strength exercises using the Swiss ball, and a stretching group (SG), in which patients performed stretching exercises. All patients participated in 40-minute training sessions three times per week for 12 weeks. The IG performed the following eight strengthening exercises using a Swiss ball: lateral rise, simultaneous biceps curl, squat, two arms triceps extension, abdominal, one arm dumbbell row, reverse crucifix and crucifix. The SG performed exercises targeting the same muscle groups trained in IG. Outcome measures were as follows: visual analogue scale (VAS) for pain, 1 repetition maximum test for muscle strength; fibromyalgia impact questionnaire (FIQ) to evaluate disease impact, and short form health survey (SF-36) to assess quality of life. All participants underwent an evaluation at baseline, at 6 weeks and at 12 weeks of training. The assessor was blind to patient allocation.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Strengthening group | Experimental | Other: strengthening exercises using a Swiss ballThis group perform muscle strengthening exercises using a Swiss ball of 65 cm diameter. |
| Stretching group | Active comparator | Other: strengthening exercisesPerformed stretching exercises |
Who may qualify
- Ages
- 20 to 65 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- female with fibromyalgia according to the classification criteria of the American College of Rheumatology;
- aged between 20 and 65 years old.
Key exclusion criteria (6 listed)
- uncontrolled hypertension;
- decompensated cardiac disease;
- history of syncope or exercise-induced arrhythmias and decompensated diabetes;
- severe psychiatric illness;
- history of regular exercise at least twice a week for the last 6 months;
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 |
|---|---|---|
| strengthening exercises using a Swiss ballThis group performed eight muscle strengthening exercises using a Swiss ball of 65 cm diameter and dumbbells with different loads. Each training session was 40 minutes long and was performed three times a week for 12 weeks. The exercises were performed in three sets of 12 repetitions, with an interval of one to two minutes of recovery between exercises, which alternated between upper limbs, lower limbs and abdomen. The load used was 60 % of one repetition maximum (1RM). | Other | Strengthening group |
| strengthening exercisesThe stretching group performed stretching exercises that targeted the same muscles trained in the IG. The participants remained in the stretched position for three sets of 30 s for each exercise. The total session time was 40 minutes. | Other | Stretching group |
Primary outcome
Changes in Pain - VAS
Time frame: Basline, after 6 and 12 weeks
3 secondary outcomes
Changes in quality of life - Fibromyalgia Impact Questionnaire (FIQ) questionnaire
Time frame: Baseline, after 6 and 12 weeks
Changes in muscle strength using the maximum repetition (1 RM)
Time frame: Baseline, after 6 and 12 weeks
Changes in consumption of analgesics
Time frame: After 6 and 12 weeks from baseline
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 14 Feb 2014.
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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 Phase 4 study testing strengthening exercises using a Swiss ball and strengthening exercises in people with Fibromyalgia, run by Federal University of São 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 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: finished, as of the sponsor's last update on 14 Feb 2014. 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Changes in Pain - VAS (time frame: Basline, after 6 and 12 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 14 Feb 2014.