FibromyalgiaNCT00545649
Development of Treatments Aiming at Improvement of Function in Patients With Chronic Widespread Pain
A study testing Exercise and education and Education in people with Fibromyalgia, run by Göteborg University at 3 sites in Sweden.
Trial summary
The study aims to evaluate the effects of adding supervised exercise in supplement to an educational self-management program, and to determine which subgroups would gain effects of the treatment. 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?
- Exercise and education and Education
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 164 participants
- Where
- 3 sitesSweden
- Study dates
- May 2004to Mar 2007
- 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
- Women with Fibromyalgia or Chronic widespread pain, aged from 18 to 60 years.
Who cannot join
- Other somatic or psychiatric disorders, inability to understand Swedish, allergy to chlorine, ongoing treatments or plans to start other treatments during the study period
Trial locations and contacts
3 sites in 1 country.
Sweden3 sites
Alingsas Primary Health Care
Alingsås
Göteborg Primary Health Care
Gothenburg
Uddevalla Primary Health Care
Uddevalla
About this study
The study aims to evaluate the effects of adding supervised exercise in supplement to an educational self-management program, and to determine which subgroups would gain effects of the treatment.
Read the detailed description
164 patients with fibromyalgia and chronic widespread pain were randomized to an exercise-education group or to education-only group. The study period was 20 week. The primary outcome measures comprised the six-minute walk test and the Fibromyalgia Impact Questionnaire. Several other self-administered instruments were included.
- Conditions
- Fibromyalgia
- Being tested
- Exercise and education, Education
- Keywords
- Fibromyalgia, chronic pain, physical, exercise, activity, education
- Medical subject headings
- Fibromyalgia, Chronic Pain, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Exercise and educationBehavioural
EducationBehavioural
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Exercise and education Receives: Behavioral: Exercise and education |
| 2 | Active comparator | Education only Receives: Behavioral: Education |
What is being measured
The primary outcome is the main question the study is designed to answer.
Body function (he six-minute walk test) and health status (the Fibromyalgia Impact Questionnaire)
Measured: 2004-2007
Secondary outcomes (1)
Self-administered questionnaires assessing distress, stress, quality of life, physical activity, fatigue
Measured: 2004-2007
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Oct 2007 (estimated)
- Study startMay 2004
- Study completionMar 2007
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.
- More trials run by Göteborg UniversityThe 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
- Single blind
- Who is masked
- Investigator
- Enrolment
- 164 participants (actual)
Sponsor and investigators
- Lead sponsor
- Göteborg University
- Sponsor type
- University, hospital or other
- Collaborators
- The Swedish Research Council
- Investigators
- Kaisa Mannerkorpi, Ass prof, Principal investigator, Göteborg University, Institute of Medicine, Department of Rheumatology and Inflammation ResearchKaisa Mannerkorpi, Ass prof, Principal investigator, Göteborg University, Institute of Medicine, Department of Rheumtology and Inflammation Research
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00545649
- Sponsor's protocol ID
- O687-03-GAU
- Status last verified
- Sep 2007
- First submitted
- 16 Oct 2007
- Last updated
- 17 Oct 2007
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Oct 2007. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Development of Treatments Aiming at Improvement of Function in Patients With Chronic Widespread Pain
- ClinicalTrials.gov ID
- NCT00545649
- Acronym / sponsor ID
- O687-03-GAU
- Conditions
- Fibromyalgia
- Keywords
- Fibromyalgia, chronic pain, physical, exercise, activity, education
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 164 participants (actual)
- Lead sponsor
- Göteborg UniversityUniversity, hospital or other
- Collaborators
- The Swedish Research Council
- Study start
- May 2004
- Study completion
- Mar 2007 (actual)
- First posted
- 17 Oct 2007 (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 study aims to evaluate the effects of adding supervised exercise in supplement to an educational self-management program, and to determine which subgroups would gain effects of the treatment.
Detailed description
164 patients with fibromyalgia and chronic widespread pain were randomized to an exercise-education group or to education-only group. The study period was 20 week. The primary outcome measures comprised the six-minute walk test and the Fibromyalgia Impact Questionnaire. Several other self-administered instruments were included.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Behavioral: Exercise and educationExercise and education |
| 2 | Active comparator | Behavioral: EducationEducation only |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- Women with Fibromyalgia or Chronic widespread pain, aged from 18 to 60 years.
Key exclusion criteria (1 listed)
- Other somatic or psychiatric disorders, inability to understand Swedish, allergy to chlorine, ongoing treatments or plans to start other treatments during the study period
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 |
|---|---|---|
| Exercise and education | Behavioural | 1 |
| Education | Behavioural | 2 |
Primary outcome
Body function (he six-minute walk test) and health status (the Fibromyalgia Impact Questionnaire)
Time frame: 2004-2007
1 secondary outcome
Self-administered questionnaires assessing distress, stress, quality of life, physical activity, fatigue
Time frame: 2004-2007
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 Oct 2007.
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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.
Kaisa Mannerkorpi, Ass prof principal investigator
Göteborg University, Institute of Medicine, Department of Rheumatology and Inflammation Research
Kaisa Mannerkorpi, Ass prof principal investigator
Göteborg University, Institute of Medicine, Department of Rheumtology and Inflammation Research
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Exercise and education and Education in people with Fibromyalgia, run by Göteborg University at 3 sites in Sweden.
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 1 inclusion and 1 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 Oct 2007. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Sweden. 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?
Body function (he six-minute walk test) and health status (the Fibromyalgia Impact Questionnaire) (time frame: 2004-2007). 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 17 Oct 2007.