Back to resultsPhysical Exercise and Its Impact on Signs of Inflammation in Fibromyalgia
Primary Purpose
Exercise Therapy, Pain
Status
Completed
Phase
Not Applicable
Locations
Sweden
Study Type
Interventional
Intervention
Physical exercise
Active comparator: low intensive exercise
Sponsored by
About this trial
This is an interventional treatment trial for Exercise Therapy focused on measuring Fibromyalgia, Physical activity, Function, Pain, Exercise, Inflammation
Eligibility Criteria
Inclusion Criteria:
- Women with Fibromyalgia, interested in exercise twice a week
Exclusion Criteria:
- Other severe diseases
Sites / Locations
- Alingsås Primary Health Care
- Sahlgrenska University Hospital, Dept of Physical Therapy
- Uddevalla Primary Health Care
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
A. High intensive exercise
B. Low-intensive exercise
Arm Description
High intensive exercise
Low-to-moderate intensive supervised walks
Outcomes
Primary Outcome Measures
Six-minute Walk Test
Patient is instructed to walk as fast as she can. The distance covered during 6 minutes is documented.
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.
Secondary Outcome Measures
Full Information
NCT ID
NCT00643006
First Posted
March 19, 2008
Last Updated
September 28, 2012
Sponsor
Göteborg University
Collaborators
Sahlgren´s University Hospital, Västra Götalands Forskningsfond, Reumatikerförbundet
1. Study Identification
Unique Protocol Identification Number
NCT00643006
Brief Title
Physical Exercise and Its Impact on Signs of Inflammation in Fibromyalgia
Official Title
Physical Exercise and Its Impact on Signs of Inflammation in Women With Fibromyalgia
Study Type
Interventional
2. Study Status
Record Verification Date
September 2012
Overall Recruitment Status
Completed
Study Start Date
January 2008 (undefined)
Primary Completion Date
May 2009 (Actual)
Study Completion Date
June 2009 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Göteborg University
Collaborators
Sahlgren´s University Hospital, Västra Götalands Forskningsfond, Reumatikerförbundet
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Exercise Therapy, Pain
Keywords
Fibromyalgia, Physical activity, Function, Pain, Exercise, Inflammation
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
67 (Actual)
8. Arms, Groups, and Interventions
Arm Title
A. High intensive exercise
Arm Type
Experimental
Arm Description
High intensive exercise
Arm Title
B. Low-intensive exercise
Arm Type
Active Comparator
Arm Description
Low-to-moderate intensive supervised walks
Intervention Type
Behavioral
Intervention Name(s)
Physical exercise
Intervention Description
Supervised walks with poles twice a week at moderate-high intensity
Intervention Type
Behavioral
Intervention Name(s)
Active comparator: low intensive exercise
Intervention Description
Supervised walks once a week at low-intensity.
Primary Outcome Measure Information:
Title
Six-minute Walk Test
Description
Patient is instructed to walk as fast as she can. The distance covered during 6 minutes is documented.
Time Frame
15 weeks
Title
Change of Pain Level From Baseline.
Description
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.
Time Frame
15 weeks
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Women with Fibromyalgia, interested in exercise twice a week
Exclusion Criteria:
Other severe diseases
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Kaisa E Mannerkorpi, Ass prof
Organizational Affiliation
Göteborg University, Dept of Rheumatology
Official's Role
Principal Investigator
Facility Information:
Facility Name
Alingsås Primary Health Care
City
Alingsås
Country
Sweden
Facility Name
Sahlgrenska University Hospital, Dept of Physical Therapy
City
Göteborg
ZIP/Postal Code
41345
Country
Sweden
Facility Name
Uddevalla Primary Health Care
City
Uddevalla
Country
Sweden
12. IPD Sharing Statement
Citations:
PubMed Identifier
23446104
Citation
Bjersing JL, Erlandsson M, Bokarewa MI, Mannerkorpi K. Exercise and obesity in fibromyalgia: beneficial roles of IGF-1 and resistin? Arthritis Res Ther. 2013 Feb 27;15(1):R34. doi: 10.1186/ar4187.
Results Reference
derived
PubMed Identifier
22776095
Citation
Bjersing JL, Dehlin M, Erlandsson M, Bokarewa MI, Mannerkorpi K. Changes in pain and insulin-like growth factor 1 in fibromyalgia during exercise: the involvement of cerebrospinal inflammatory factors and neuropeptides. Arthritis Res Ther. 2012 Jul 9;14(4):R162. doi: 10.1186/ar3902.
Results Reference
derived
PubMed Identifier
20942911
Citation
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. doi: 10.1186/ar3159. Epub 2010 Oct 13.
Results Reference
derived
Learn more about this trial
Physical Exercise and Its Impact on Signs of Inflammation in Fibromyalgia
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