Fibromyalgia SyndromeNCT01029041
Stretching and Strengthening Exercise in Fibromyalgia Patients
A study testing Strengthening Exercises and Stretching exercises in people with Fibromyalgia Syndrome, run by University of Sao Paulo General Hospital at 1 site in Brazil.
Trial summary
Fibromyalgia is a rheumatologic syndrome characterized by widespread chronic pain, tender points and other symptoms as fatigue, sleep disturbances, anxiety and depression. Therapeutic exercises are described as an important form to management of symptoms. Read more about this study
- Who is it for?
- Ages 30 to 55 years, women only
- Conditions the study is for
- Fibromyalgia Syndrome
- What is being tested?
- Strengthening Exercises and Stretching exercises
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 63 participants
- Where
- 1 siteBrazil
- Study dates
- Aug 2007to Nov 2009
- 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 55 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- Fibromyalgia diagnosis according to American Rheumatology Criteria
- Aged between 30 and 55 years old
Who cannot join
- Severe rheumatologic syndromes
- neurologic syndromes
Trial locations and contacts
1 site in 1 country.
Brazil1 site
Medicine School of University of Sao Paulo
São Paulo, São Paulo, 01246903
About this study
Official title: Stretching and Strengthening Exercise in Treatment of Fibromyalgia Patients: a Randomized Clinical Trial
Fibromyalgia is a rheumatologic syndrome characterized by widespread chronic pain, tender points and other symptoms as fatigue, sleep disturbances, anxiety and depression. Therapeutic exercises are described as an important form to management of symptoms. This study aims to assess strengthening and stretching exercise efficacy in symptoms and quality of life of Fibromyalgia patients. The study is done at General Clinical Hospital of Medicine Scholl of University of Sao Paulo. 63 subjects undergo the study and they are divided into three groups: 1 strengthening exercise, 2 stretching exercise and 3 control group. Patients are evaluated by following instruments: Fibromyalgia Impact Questionnaire, Medical Outcomes Study 36-item Short-Form Health Survey (SF-36), Stanford Health Assessment Questionnaire, dolorimetry at tender points by a Fischer dolorimeter, finger-to-tip floor test for muscular flexibility, dynamometer EMG System do Brasil for strength test of extension and flexion of knees and elbows, time to get up and go test, functional reach test, sit-to-stand test. Subjects of 1 strengthening exercise group undergo a global strengthening program and 2 stretching exercise group undergo a global stretching program. All programs have 12 weeks of duration and physical therapy is twice a week. The control group does not do any intervention during 12 weeks and after the second evaluation they enter the common program of physical therapy. Data are being analyzed by descriptive and interferential statistics procedures.
Read the detailed description
In this study, were included subjects with fibromyalgia diagnosis aged between 30 and 55 years old. We aimed to assess the effect of a physical therapy program on impact of fibromyalgia syndrome and quality of life.
- Conditions
- Fibromyalgia Syndrome
- Being tested
- Strengthening Exercises, Stretching exercises
- Keywords
- fibromyalgia, exercise, strength, stretch
- 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.
Strengthening ExercisesOther
Also called strengh exercise
Exercises that aim the improvement of muscular strength of arms and legs
Stretching exercisesOther
Also called flexibility exercise
Exercises that aim the improvement of muscular flexibility of arms, legs and spine
| Study group | Role | What they receive |
|---|---|---|
| Strengthening exercise | Experimental | This group does global strengthening exercise Receives: Other: Strengthening Exercises |
| Stretching exercise | Experimental | This group does global stretching exercise Receives: Other: Stretching exercises |
| Control | No intervention | This group does nor do any kind of exercise during the study |
What is being measured
The primary outcome is the main question the study is designed to answer.
Fibromyalgia Impact Questionnaire
Measured: before and after treatment
Secondary outcomes (1)
Medical Outcomes Study 36-item Short-Form Health Survey (SF-36), Stanford Health Assessment Questionnaire
Measured: before and after treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Dec 2009 (estimated)
- Study startAug 2007
- Primary completionOct 2009
- Study completionNov 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Fibromyalgia SyndromeStudies of the same condition, open and under way.
- More trials run by University of Sao Paulo General HospitalThe 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
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 63 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Sao Paulo General Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Fundação de Amparo à Pesquisa do Estado de São Paulo
- Investigators
- Amélia P Marques, PhD, Study chair, University of Sao Paulo
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01029041
- Sponsor's protocol ID
- Cappesq 0337/07
- Status last verified
- Dec 2009
- First submitted
- 8 Dec 2009
- Last updated
- 9 Dec 2009
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Dec 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Stretching and Strengthening Exercise in Treatment of Fibromyalgia Patients: a Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT01029041
- Acronym / sponsor ID
- Cappesq 0337/07
- Conditions
- Fibromyalgia Syndrome
- Keywords
- fibromyalgia, exercise, strength, stretch
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 63 participants (actual)
- Lead sponsor
- University of Sao Paulo General HospitalUniversity, hospital or other
- Collaborators
- Fundação de Amparo à Pesquisa do Estado de São Paulo
- Study start
- Aug 2007
- Primary completion
- Oct 2009 (actual)
- Study completion
- Nov 2009 (actual)
- First posted
- 9 Dec 2009 (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.
Fibromyalgia is a rheumatologic syndrome characterized by widespread chronic pain, tender points and other symptoms as fatigue, sleep disturbances, anxiety and depression. Therapeutic exercises are described as an important form to management of symptoms. This study aims to assess strengthening and stretching exercise efficacy in symptoms and quality of life of Fibromyalgia patients. The study is done at General Clinical Hospital of Medicine Scholl of University of Sao Paulo. 63 subjects undergo the study and they are divided into three groups: 1 strengthening exercise, 2 stretching exercise and 3 control group. Patients are evaluated by following instruments: Fibromyalgia Impact Questionnaire, Medical Outcomes Study 36-item Short-Form Health Survey (SF-36), Stanford Health Assessment Questionnaire, dolorimetry at tender points by a Fischer dolorimeter, finger-to-tip floor test for muscular flexibility, dynamometer EMG System do Brasil for strength test of extension and flexion of knees and elbows, time to get up and go test, functional reach test, sit-to-stand test. Subjects of 1 strengthening exercise group undergo a global strengthening program and 2 stretching exercise group undergo a global stretching program. All programs have 12 weeks of duration and physical therapy is twice a week. The control group does not do any intervention during 12 weeks and after the second evaluation they enter the common program of physical therapy. Data are being analyzed by descriptive and interferential statistics procedures.
Detailed description
In this study, were included subjects with fibromyalgia diagnosis aged between 30 and 55 years old. We aimed to assess the effect of a physical therapy program on impact of fibromyalgia syndrome and quality of life.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Strengthening exercise | Experimental | Other: Strengthening ExercisesThis group does global strengthening exercise |
| Stretching exercise | Experimental | Other: Stretching exercisesThis group does global stretching exercise |
| Control | No intervention | –This group does nor do any kind of exercise during the study |
Who may qualify
- Ages
- 30 to 55 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Fibromyalgia diagnosis according to American Rheumatology Criteria
- Aged between 30 and 55 years old
Key exclusion criteria (2 listed)
- Severe rheumatologic syndromes
- neurologic syndromes
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 ExercisesAlso: strengh exerciseExercises that aim the improvement of muscular strength of arms and legs | Other | Strengthening exercise |
| Stretching exercisesAlso: flexibility exerciseExercises that aim the improvement of muscular flexibility of arms, legs and spine | Other | Stretching exercise |
Primary outcome
Fibromyalgia Impact Questionnaire
Time frame: before and after treatment
1 secondary outcome
Medical Outcomes Study 36-item Short-Form Health Survey (SF-36), Stanford Health Assessment Questionnaire
Time frame: before and after treatment
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 9 Dec 2009.
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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.
Amélia P Marques, PhD study chair
University of Sao 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 Strengthening Exercises and Stretching exercises in people with Fibromyalgia Syndrome, run by University of Sao Paulo General Hospital 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 2 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 9 Dec 2009. 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?
Fibromyalgia Impact Questionnaire (time frame: before and after treatment). 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 9 Dec 2009.