Text Size

Physical Exercise and Its Impact on Signs of Inflammation in Fibromyalgia

This study has been completed.
Sponsor:
Collaborators:
Sahlgren´s University Hospital
Västra Götalands Forskningsfond
Reumatikerförbundet
Information provided by (Responsible Party):
Göteborg University
ClinicalTrials.gov Identifier:
NCT00643006
First received: March 19, 2008
Last updated: September 28, 2012
Last verified: September 2012
History of Changes
  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
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:

U.S. FDA Resources

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.

  Eligibility

Ages Eligible for Study:   18 Years to 60 Years
Genders 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
Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided by Göteborg University

Additional 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
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:
Fibromyalgia
Physical activity
Function
 Pain
Exercise
Inflammation

Additional relevant MeSH terms:
Fibromyalgia
Myofascial Pain Syndromes
Inflammation
Muscular Diseases
Musculoskeletal Diseases
 Rheumatic Diseases
Neuromuscular Diseases
Nervous System Diseases
Pathologic Processes

ClinicalTrials.gov processed this record on May 23, 2013