Physical Exercise and Its Impact on Signs of Inflammation in Fibromyalgia

This study has been completed.
Sahlgren´s University Hospital
Västra Götalands Forskningsfond
Information provided by (Responsible Party):
Göteborg University Identifier:
First received: March 19, 2008
Last updated: September 28, 2012
Last verified: September 2012

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
Behavioral: Physical exercise
Behavioral: Active comparator: low intensive exercise

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: Yes ]
    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.


Ages Eligible for Study:   18 Years to 60 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Women with Fibromyalgia, interested in exercise twice a week

Exclusion Criteria:

  • Other severe diseases
  Contacts and Locations
Please refer to this study by its identifier: NCT00643006

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

No publications provided by Göteborg University

Additional publications automatically indexed to this study by Identifier (NCT Number):
Responsible Party: Göteborg University Identifier: NCT00643006     History of Changes
Other Study ID Numbers: GAU2
Study First Received: March 19, 2008
Results First Received: May 3, 2012
Last Updated: September 28, 2012
Health Authority: Sweden: Regional Ethical Review Board

Keywords provided by Göteborg University:
Physical activity

Additional relevant MeSH terms:
Myofascial Pain Syndromes
Muscular Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Neuromuscular Diseases
Nervous System Diseases
Pathologic Processes processed this record on April 14, 2014