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Physical Exercise and Its Impact on Signs of Inflammation in Fibromyalgia

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00643006
First Posted: March 25, 2008
Last Update Posted: October 30, 2012
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.
Collaborators:
Sahlgren´s University Hospital
Västra Götalands Forskningsfond
Reumatikerförbundet
Information provided by (Responsible Party):
Göteborg University
  Purpose
The study aims to compare low-intensive and high-intensive physical exercise and its impact on physical function, pain and signs of inflammation.

Condition Intervention
Exercise Therapy Pain Behavioral: Physical exercise Behavioral: Active comparator: low intensive exercise

Study Type: Interventional
Study Design: 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

Resource links provided by NLM:


Further study details as provided by Göteborg University:

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.


Enrollment: 67
Study Start Date: January 2008
Study Completion Date: June 2009
Primary Completion Date: May 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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
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
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):
Responsible Party: Göteborg University
ClinicalTrials.gov Identifier: NCT00643006     History of Changes
Other Study ID Numbers: GAU2
First Submitted: March 19, 2008
First Posted: March 25, 2008
Results First Submitted: May 3, 2012
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:
Inflammation
Fibromyalgia
Myofascial Pain Syndromes
Pathologic Processes
Muscular Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Neuromuscular Diseases
Nervous System Diseases