Exercise TherapyNCT00643006
Physical Exercise and Its Impact on Signs of Inflammation in Fibromyalgia
A study testing Physical exercise and Active comparator: low intensive exercise in people with Exercise Therapy and Pain, run by Göteborg University at 3 sites in Sweden.
Trial summary
The study aims to compare low-intensive and high-intensive physical exercise and its impact on physical function, pain and signs of inflammation. Read more about this study
- Who is it for?
- Ages 18 to 60 years, women only
- Conditions the study is for
- Exercise Therapy, Pain
- What is being tested?
- Physical exercise and Active comparator: low intensive exercise
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 67 participants
- Where
- 3 sitesSweden
- Study dates
- Jan 2008to Jun 2009
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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, interested in exercise twice a week
Who cannot join
- Other severe diseases
Trial locations and contacts
3 sites in 1 country.
Sweden3 sites
Alingsås Primary Health Care
Alingsås
Sahlgrenska University Hospital, Dept of Physical Therapy
Gothenburg, 41345
Uddevalla Primary Health Care
Uddevalla
About this study
Official title: Physical Exercise and Its Impact on Signs of Inflammation in Women With Fibromyalgia
The study aims to compare low-intensive and high-intensive physical exercise and its impact on physical function, pain and signs of inflammation.
- Conditions
- Exercise Therapy, Pain
- Being tested
- Physical exercise, Active comparator: low intensive exercise
- Keywords
- Fibromyalgia, Physical activity, Function, Pain, Exercise, Inflammation
- Medical subject headings
- Pain, Fibromyalgia, Motor Activity, Inflammation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Physical exerciseBehavioural
Supervised walks with poles twice a week at moderate-high intensity
Active comparator: low intensive exerciseBehavioural
Supervised walks once a week at low-intensity.
| Study group | Role | What they receive |
|---|---|---|
| A. High intensive exercise | Experimental | High intensive exercise Receives: Behavioral: Physical exercise |
| B. Low-intensive exercise | Active comparator | Low-to-moderate intensive supervised walks Receives: Behavioral: Active comparator: low intensive exercise |
What is being measured
The primary outcome is the main question the study is designed to answer.
Six-minute Walk Test
Patient is instructed to walk as fast as she can. The distance covered during 6 minutes is documented.
Measured: 15 weeks
Change of Pain Level From Baseline.
Pain was measured by The Fibromyalgia Impact Questionnaire (FIQ) subscale for Pain, which is a self-rated pain on visual analogue scale, 0-100 mm. The higher value, the worse pain.
Measured: 15 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Mar 2008 (estimated)
- Study startJan 2008
- Primary completionMay 2009
- Study completionJun 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Exercise TherapyStudies 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
- Outcomes assessor
- Enrolment
- 67 participants (actual)
Sponsor and investigators
- Lead sponsor
- Göteborg University
- Sponsor type
- University, hospital or other
- Collaborators
- Sahlgrenska University Hospital, Västra Götalands Forskningsfond, Reumatikerförbundet
- Responsible party
- Sponsor
- Investigators
- Kaisa E Mannerkorpi, Ass prof, Principal investigator, Göteborg University, Dept of Rheumatology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00643006
- Sponsor's protocol ID
- GAU2
- Status last verified
- Sep 2012
- First submitted
- 19 Mar 2008
- Last updated
- 30 Oct 2012
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Publications
Bjersing JL, Erlandsson M, Bokarewa MI, Mannerkorpi K. Exercise and obesity in fibromyalgia: beneficial roles of IGF-1 and resistin? Arthritis Res Ther. 2013 Feb 27;15(1):R34. doi: 10.1186/ar4187.
PubMed 23446104Bjersing JL, Dehlin M, Erlandsson M, Bokarewa MI, Mannerkorpi K. Changes in pain and insulin-like growth factor 1 in fibromyalgia during exercise: the involvement of cerebrospinal inflammatory factors and neuropeptides. Arthritis Res Ther. 2012 Jul 9;14(4):R162. doi: 10.1186/ar3902.
PubMed 22776095Mannerkorpi K, Nordeman L, Cider A, Jonsson G. Does moderate-to-high intensity Nordic walking improve functional capacity and pain in fibromyalgia? A prospective randomized controlled trial. Arthritis Res Ther. 2010;12(5):R189. doi: 10.1186/ar3159. Epub 2010 Oct 13.
PubMed 20942911
Study at a glance
From the registry record, last updated by the sponsor on 30 Oct 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Physical Exercise and Its Impact on Signs of Inflammation in Women With Fibromyalgia
- ClinicalTrials.gov ID
- NCT00643006
- Acronym / sponsor ID
- GAU2
- Conditions
- Exercise Therapy, Pain
- Keywords
- Fibromyalgia, Physical activity, Function, Pain, Exercise, Inflammation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 67 participants (actual)
- Lead sponsor
- Göteborg UniversityUniversity, hospital or other
- Collaborators
- Sahlgrenska University Hospital, Västra Götalands Forskningsfond, Reumatikerförbundet
- Study start
- Jan 2008
- Primary completion
- May 2009 (actual)
- Study completion
- Jun 2009 (actual)
- First posted
- 25 Mar 2008 (estimated)
- Results
- Posted 30 Oct 2012
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 compare low-intensive and high-intensive physical exercise and its impact on physical function, pain and signs of inflammation.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| A. High intensive exercise | Experimental | Behavioral: Physical exerciseHigh intensive exercise |
| B. Low-intensive exercise | Active comparator | Behavioral: Active comparator: low intensive exerciseLow-to-moderate intensive supervised walks |
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, interested in exercise twice a week
Key exclusion criteria (1 listed)
- Other severe diseases
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 |
|---|---|---|
| Physical exerciseSupervised walks with poles twice a week at moderate-high intensity | Behavioural | A. High intensive exercise |
| Active comparator: low intensive exerciseSupervised walks once a week at low-intensity. | Behavioural | B. Low-intensive exercise |
Primary outcome
Six-minute Walk Test
Time frame: 15 weeks
Patient is instructed to walk as fast as she can. The distance covered during 6 minutes is documented.
Change of Pain Level From Baseline.
Time frame: 15 weeks
Pain was measured by The Fibromyalgia Impact Questionnaire (FIQ) subscale for Pain, which is a self-rated pain on visual analogue scale, 0-100 mm. The higher value, the worse pain.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Oct 2012.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 23446104Bjersing JL, Erlandsson M, Bokarewa MI, Mannerkorpi K. Exercise and obesity in fibromyalgia: beneficial roles of IGF-1 and resistin? Arthritis Res Ther. 2013 Feb 27;15(1):R34. doi: 10.1186/ar4187.
- Derived from this study: PubMed 22776095Bjersing JL, Dehlin M, Erlandsson M, Bokarewa MI, Mannerkorpi K. Changes in pain and insulin-like growth factor 1 in fibromyalgia during exercise: the involvement of cerebrospinal inflammatory factors and neuropeptides. Arthritis Res Ther. 2012 Jul 9;14(4):R162. doi: 10.1186/ar3902.
- Derived from this study: PubMed 20942911Mannerkorpi K, Nordeman L, Cider A, Jonsson G. Does moderate-to-high intensity Nordic walking improve functional capacity and pain in fibromyalgia? A prospective randomized controlled trial. Arthritis Res Ther. 2010;12(5):R189. doi: 10.1186/ar3159. Epub 2010 Oct 13.
Related trials for Exercise Therapy
Not yet recruiting
Feasibility of a Robot-Guided Active Play Intervention for Children With Cerebral Palsy
Cerebral Palsy
Enrolling by invitation
Online Exercise Program for Transplant Patients: A Pilot Study
Kidney Transplantation, Physical Function
Not yet recruitingPhase 2
Alberta Cancer Exercise Dose in Colorectal Cancer
Cancer, Colorectal Cancer
Active, not recruiting
Effectiveness of Therapeutic Exercises on Spinopelvic Mobility
Osteoarthritis (OA) of the Hip
Not yet recruiting
Testing a Smartphone App to Support a Mediterranean Diet and Strength Exercise
Treatment Adherence and Compliance, Resistance Exercise
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 E Mannerkorpi, Ass prof principal investigator
Göteborg University, Dept of Rheumatology
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Physical exercise and Active comparator: low intensive exercise in people with Exercise Therapy and Pain, 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 30 Oct 2012. 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?
Yes. Results are posted in the registry (first posted 30 Oct 2012). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Six-minute Walk Test (time frame: 15 weeks). The study lists 2 primary outcomes in all. 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 NCT00643006, which also lists 3 linked publications.
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 Oct 2012.