Physical Exercise and Its Impact on Signs of Inflammation in Fibromyalgia

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ClinicalTrials.gov Identifier: NCT00643006

Recruitment Status : Completed

First Posted : March 25, 2008

Results First Posted : October 30, 2012

Last Update Posted : October 30, 2012

Sponsor:

Collaborators:

Sahlgren´s University Hospital

Västra Götalands Forskningsfond

Reumatikerförbundet

Information provided by (Responsible Party):

Göteborg University

Study Description

Brief Summary:

The study aims to compare low-intensive and high-intensive physical exercise and its impact on physical function, pain and signs of inflammation.

Condition or disease	Intervention/treatment	Phase
Exercise Therapy Pain	Behavioral: Physical exercise Behavioral: Active comparator: low intensive exercise	Not Applicable

Study Design

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Study Type :	Interventional (Clinical Trial)
Actual Enrollment :	67 participants
Allocation:	Randomized
Intervention Model:	Parallel Assignment
Masking:	Single (Outcomes Assessor)
Primary Purpose:	Treatment
Official Title:	Physical Exercise and Its Impact on Signs of Inflammation in Women With Fibromyalgia
Study Start Date :	January 2008
Actual Primary Completion Date :	May 2009
Actual Study Completion Date :	June 2009

Resource links provided by the National Library of Medicine

MedlinePlus Genetics related topics: Fibromyalgia

MedlinePlus related topics: Exercise and Physical Fitness Fibromyalgia Health Checkup

U.S. FDA Resources

Arms and Interventions

Arm	Intervention/treatment
Experimental: A. High intensive exercise High intensive exercise	Behavioral: Physical exercise Supervised walks with poles twice a week at moderate-high intensity
Active Comparator: B. Low-intensive exercise Low-to-moderate intensive supervised walks	Behavioral: Active comparator: low intensive exercise Supervised walks once a week at low-intensity.

Outcome Measures

Primary Outcome Measures :

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.

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:	18 Years to 60 Years (Adult)
Sexes Eligible for Study:	Female
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Women with Fibromyalgia, interested in exercise twice a week

Exclusion Criteria:

Other severe diseases

Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00643006

Locations

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Sweden
Alingsås Primary Health Care
Alingsås, Sweden
Sahlgrenska University Hospital, Dept of Physical Therapy
Göteborg, Sweden, 41345
Uddevalla Primary Health Care
Uddevalla, Sweden

Sponsors and Collaborators

Göteborg University

Sahlgren´s University Hospital

Västra Götalands Forskningsfond

Reumatikerförbundet

Investigators

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Principal Investigator:	Kaisa E Mannerkorpi, Ass prof	Göteborg University, Dept of Rheumatology

More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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.

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Responsible Party:	Göteborg University
ClinicalTrials.gov Identifier:	NCT00643006
Other Study ID Numbers:	GAU2
First Posted:	March 25, 2008 Key Record Dates
Results First Posted:	October 30, 2012
Last Update Posted:	October 30, 2012
Last Verified:	September 2012

Keywords provided by Göteborg University:


Fibromyalgia Physical activity Function	Pain Exercise Inflammation

Additional relevant MeSH terms:

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Fibromyalgia Myofascial Pain Syndromes Inflammation Pathologic Processes Muscular Diseases	Musculoskeletal Diseases Rheumatic Diseases Neuromuscular Diseases Nervous System Diseases

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