FibromyalgiaNCT01592916
Acute Effects of Exercise in Women With Fibromyalgia (FM)
An observational study of Fibromyalgia, run by Göteborg University at 1 site in Sweden.
Trial summary
The investigators previous studies of aerobic exercise in women with fibromyalgia (FM) have shown that exercise improves body functions and/or symptom severity in most patients, but not in all. About a third of patients with FM have been shown to have low levels of IGF-1. Read more about this study
- Who is it for?
- Ages 20 to 50 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Fibromyalgia
- How many people
- 55 participants
- Where
- 1 siteSweden
- Study dates
- 10 May 2012to 23 Nov 2012
- Phase
- Observational
- 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 50 years
- Women only
- Healthy volunteers accepted
- Adult
Study population: The participants are recruited from previous studies.
Who may be able to join
- clinical diagnosis of fibromyalgia
- age 20-50 years
Who cannot join
- heart disease
- neurological disease
- severe osteoarthritis
Trial locations and contacts
1 site in 1 country.
Sweden1 site
Sahlgrenska University Hospital, Dept of Physical Therapy
Gothenburg, 41345
About this study
Official title: Acute Effects of Exercise in Women With FM
The investigators previous studies of aerobic exercise in women with fibromyalgia (FM) have shown that exercise improves body functions and/or symptom severity in most patients, but not in all. About a third of patients with FM have been shown to have low levels of IGF-1. The purpose of this project is to study individual and biological factors that interact with outcomes of short-term (acute) exercise in FM.
Method. A controlled prospective exercise study. Thirty women with FM and 30 healthy age-matched women, aged 20-50 years, will be recruited to the study. Two 15-minute ergometer bicycle exercise tests will be conducted in feasting patients, separated by one month. The first exercise test is at a low and the second at a high intensity. Measurements comprise blood test, pain rating and pain threshold, conducted before and after the test. The levels of IGF-1, IL-6 and IL-8 will be measured, and the changes in them will be related to health status and pain.
- Conditions
- Fibromyalgia
- Keywords
- Fibromyalgia, Pain, Women, Exercise, IGF1
- Medical subject headings
- Fibromyalgia, Pain, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Fibromyalgia | Women with fibromyalgia, aged 20-50 years | |
| Healthy controls | Women without severe disease, aged 20-50 years |
What is being measured
The primary outcome is the main question the study is designed to answer.
IGF1 level
Ergometer cycle test of 15 minutes at low respective high intensity. Blood test is done before and after exercise. Change in quantity of IGF1 is measured.
Measured: 15 min
Secondary outcomes (3)
Pain rating
Pain is rated by the test person before and after the ergometer cycle test.
Measured: 15 minutes
Pain threshold
Pain threshold is measured before and after the ergometer test.
Measured: 15 minutes
Interleukin 6 and 8
Blood test is done before and after the ergometer bicycle test. Quantity of interleukin 6 and 8 is measured.
Measured: 15 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 May 2012 (estimated)
- Study start10 May 2012
- Primary completion23 Nov 2012
- Study completion23 Nov 2012
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.
- 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
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 55 participants (actual)
Sponsor and investigators
- Lead sponsor
- Göteborg University
- Sponsor type
- University, hospital or other
- Collaborators
- Sahlgrenska University Hospital, The Swedish Research Council
- Responsible party
- Sponsor
- Investigators
- Kaisa Mannerkorpi, Assoc prof, Principal investigator, Göteborg University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01592916
- Sponsor's protocol ID
- GU-143-12
- Status last verified
- Feb 2018
- First submitted
- 4 May 2012
- Last updated
- 5 Feb 2018
- Results posted
- No
- Data monitoring committee
- No
Publications
Mannerkorpi K, Landin-Wilhelmsen K, Larsson A, Cider A, Arodell O, Bjersing JL. Acute effects of physical exercise on the serum insulin-like growth factor system in women with fibromyalgia. BMC Musculoskelet Disord. 2017 Jan 25;18(1):37. doi: 10.1186/s12891-017-1402-y.
PubMed 28122522
Study at a glance
From the registry record, last updated by the sponsor on 5 Feb 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Acute Effects of Exercise in Women With FM
- ClinicalTrials.gov ID
- NCT01592916
- Acronym / sponsor ID
- GU-143-12
- Conditions
- Fibromyalgia
- Keywords
- Fibromyalgia, Pain, Women, Exercise, IGF1
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 55 participants (actual)
- Lead sponsor
- Göteborg UniversityUniversity, hospital or other
- Collaborators
- Sahlgrenska University Hospital, The Swedish Research Council
- Study start
- 10 May 2012 (actual)
- Primary completion
- 23 Nov 2012 (actual)
- Study completion
- 23 Nov 2012 (actual)
- First posted
- 7 May 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 investigators previous studies of aerobic exercise in women with fibromyalgia (FM) have shown that exercise improves body functions and/or symptom severity in most patients, but not in all. About a third of patients with FM have been shown to have low levels of IGF-1. The purpose of this project is to study individual and biological factors that interact with outcomes of short-term (acute) exercise in FM.
Method. A controlled prospective exercise study. Thirty women with FM and 30 healthy age-matched women, aged 20-50 years, will be recruited to the study. Two 15-minute ergometer bicycle exercise tests will be conducted in feasting patients, separated by one month. The first exercise test is at a low and the second at a high intensity. Measurements comprise blood test, pain rating and pain threshold, conducted before and after the test. The levels of IGF-1, IL-6 and IL-8 will be measured, and the changes in them will be related to health status and pain.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Fibromyalgia | – | –Women with fibromyalgia, aged 20-50 years |
| Healthy controls | – | –Women without severe disease, aged 20-50 years |
Who may qualify
- Ages
- 20 to 50 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- The participants are recruited from previous studies.
Key inclusion criteria (2 listed)
- clinical diagnosis of fibromyalgia
- age 20-50 years
Key exclusion criteria (3 listed)
- heart disease
- neurological disease
- severe osteoarthritis
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
IGF1 level
Time frame: 15 min
Ergometer cycle test of 15 minutes at low respective high intensity. Blood test is done before and after exercise. Change in quantity of IGF1 is measured.
3 secondary outcomes
Pain rating
Time frame: 15 minutes
Pain threshold
Time frame: 15 minutes
Interleukin 6 and 8
Time frame: 15 minutes
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 5 Feb 2018.
- Results publication: PubMed 28122522Mannerkorpi K, Landin-Wilhelmsen K, Larsson A, Cider A, Arodell O, Bjersing JL. Acute effects of physical exercise on the serum insulin-like growth factor system in women with fibromyalgia. BMC Musculoskelet Disord. 2017 Jan 25;18(1):37. doi: 10.1186/s12891-017-1402-y.
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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, Assoc prof principal investigator
Göteborg University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Fibromyalgia, run by Göteborg University at 1 site 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 2 inclusion and 3 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 5 Feb 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 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?
IGF1 level (time frame: 15 min). 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 NCT01592916, 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 5 Feb 2018.