Physical Exercise and Its Impact on Signs of Inflammation in Fibromyalgia

Pain Clinical Trial

Official title:

Physical Exercise and Its Impact on Signs of Inflammation in Women With Fibromyalgia

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00643006
• Other study ID #: GAU2
• Status: Completed
• Phase: N/A
• First received: March 19, 2008
• Last updated: September 28, 2012
• Start date: January 2008
• Est. completion date: June 2009

Study information

• Verified date: September 2012
• Source: Göteborg University
• Contact: n/a
• Is FDA regulated: No
• Health authority: Sweden: Regional Ethical Review Board
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 67
• Est. completion date: June 2009
• Est. primary completion date: May 2009
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 60 Years

Eligibility

Inclusion Criteria:

• Women with Fibromyalgia, interested in exercise twice a week

Exclusion Criteria:

• Other severe diseases

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Exercise Therapy
• Fibromyalgia
• Inflammation
• Myofascial Pain Syndromes
• Pain

Intervention

Behavioral:
• Physical exercise
Supervised walks with poles twice a week at moderate-high intensity
• Active comparator: low intensive exercise
Supervised walks once a week at low-intensity.

Locations

Country	Name	City	State
Sweden	Alingsås Primary Health Care	Alingsås
Sweden	Sahlgrenska University Hospital, Dept of Physical Therapy	Göteborg
Sweden	Uddevalla Primary Health Care	Uddevalla

Sponsors (4)

Lead Sponsor	Collaborator
Göteborg University	Reumatikerförbundet, Sahlgren´s University Hospital, Västra Götalands Forskningsfond

Country where clinical trial is conducted

Sweden, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Six-minute Walk Test	Patient is instructed to walk as fast as she can. The distance covered during 6 minutes is documented.	15 weeks	No
Primary	Change of Pain Level From Baseline.	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.	15 weeks	Yes