Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

Tracking Information
First Submitted Date  ICMJE March 19, 2008
First Posted Date  ICMJE March 25, 2008
Results First Submitted Date  ICMJE May 3, 2012
Results First Posted Date  ICMJE October 30, 2012
Last Update Posted Date October 30, 2012
Study Start Date  ICMJE January 2008
Actual Primary Completion Date May 2009   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: September 28, 2012)
  • 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.
Original Primary Outcome Measures  ICMJE
 (submitted: March 19, 2008)
  • physical function [ Time Frame: 15 weeks ]
  • pain [ Time Frame: 15 weeks ]
Change History Complete list of historical versions of study NCT00643006 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE
 (submitted: March 19, 2008)
signs of inflammation [ Time Frame: 15 weeks ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Physical Exercise and Its Impact on Signs of Inflammation in Fibromyalgia
Official Title  ICMJE Physical Exercise and Its Impact on Signs of Inflammation in Women With Fibromyalgia
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE
  • Exercise Therapy
  • Pain
Intervention  ICMJE
  • 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.
Study Arms  ICMJE
  • 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
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: September 28, 2012)
67
Original Estimated Enrollment  ICMJE
 (submitted: March 19, 2008)
70
Actual Study Completion Date  ICMJE June 2009
Actual Primary Completion Date May 2009   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Women with Fibromyalgia, interested in exercise twice a week

Exclusion Criteria:

  • Other severe diseases
Sex/Gender  ICMJE
Sexes Eligible for Study: Female
Ages  ICMJE 18 Years to 60 Years   (Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Sweden
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00643006
Other Study ID Numbers  ICMJE GAU2
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Göteborg University
Study Sponsor  ICMJE Göteborg University
Collaborators  ICMJE
  • Sahlgren´s University Hospital
  • Västra Götalands Forskningsfond
  • Reumatikerförbundet
Investigators  ICMJE
Principal Investigator: Kaisa E Mannerkorpi, Ass prof Göteborg University, Dept of Rheumatology
PRS Account Göteborg University
Verification Date September 2012

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