Physical Exercise and Its Impact on Signs of Inflammation in Fibromyalgia
September 28, 2012 updated by: Göteborg University
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
67
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
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Alingsås, Sweden
- Alingsas Primary Health Care
-
Göteborg, Sweden, 41345
- Sahlgrenska University Hospital, Dept of Physical Therapy
-
Uddevalla, Sweden
- Uddevalla Primary Health Care
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 60 years (Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
Female
Description
Inclusion Criteria:
- Women with Fibromyalgia, interested in exercise twice a week
Exclusion Criteria:
- Other severe diseases
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: A. High intensive exercise
High intensive exercise
|
Supervised walks with poles twice a week at moderate-high intensity
|
|
Active Comparator: B. Low-intensive exercise
Low-to-moderate intensive supervised walks
|
Supervised walks once a week at low-intensity.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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.
|
15 weeks
|
|
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.
|
15 weeks
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General 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.
- Bjersing 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.
- Mannerkorpi 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.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
January 1, 2008
Primary Completion (Actual)
May 1, 2009
Study Completion (Actual)
June 1, 2009
Study Registration Dates
First Submitted
March 19, 2008
First Submitted That Met QC Criteria
March 19, 2008
First Posted (Estimate)
March 25, 2008
Study Record Updates
Last Update Posted (Estimate)
October 30, 2012
Last Update Submitted That Met QC Criteria
September 28, 2012
Last Verified
September 1, 2012
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- GAU2
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.