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

March 19, 2008
September 28, 2012
January 2008
May 2009   (final data collection date for primary outcome measure)
  • 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.
  • pain [ Time Frame: 15 weeks ] [ Designated as safety issue: Yes ]
  • physical function [ Time Frame: 15 weeks ] [ Designated as safety issue: No ]
Complete list of historical versions of study NCT00643006 on ClinicalTrials.gov Archive Site
Not Provided
signs of inflammation [ Time Frame: 15 weeks ] [ Designated as safety issue: No ]
Not Provided
Not Provided
 
Physical Exercise and Its Impact on Signs of Inflammation in Fibromyalgia
Physical Exercise and Its Impact on Signs of Inflammation in Women With Fibromyalgia

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

Not Provided
Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
  • Exercise Therapy
  • Pain
  • Behavioral: Physical exercise
    Supervised walks with poles twice a week at moderate-high intensity
  • Behavioral: Active comparator: low intensive exercise
    Supervised walks once a week at low-intensity.
  • Experimental: A. High intensive exercise
    High intensive exercise
    Intervention: Behavioral: Physical exercise
  • Active Comparator: B. Low-intensive exercise
    Low-to-moderate intensive supervised walks
    Intervention: Behavioral: Active comparator: low intensive exercise
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. Epub 2010 Oct 13.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
67
June 2009
May 2009   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Women with Fibromyalgia, interested in exercise twice a week

Exclusion Criteria:

  • Other severe diseases
Female
18 Years to 60 Years
No
Contact information is only displayed when the study is recruiting subjects
Sweden
 
NCT00643006
GAU2
No
Göteborg University
Göteborg University
  • Sahlgren´s University Hospital
  • Västra Götalands Forskningsfond
  • Reumatikerförbundet
Principal Investigator: Kaisa E Mannerkorpi, Ass prof Göteborg University, Dept of Rheumatology
Göteborg University
September 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP