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Physical Exercise and Its Impact on Signs of Inflammation in Fibromyalgia

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
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
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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


Arms and Interventions
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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
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Primary Outcome Measures :
  1. 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.

  2. 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
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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
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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
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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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