Acute Effects of Exercise in Women With Fibromyalgia (FM)

This study is currently recruiting participants. (see Contacts and Locations)
Verified May 2015 by Göteborg University
Sahlgrenska University Hospital, Sweden
The Swedish Research Council
Information provided by (Responsible Party):
Göteborg University Identifier:
First received: May 4, 2012
Last updated: May 28, 2015
Last verified: May 2015

The investigators previous studies of aerobic exercise in women with fibromyalgia (FM) have shown that exercise improves body functions and/or symptom severity in most patients, but not in all. About a third of patients with FM have been shown to have low levels of IGF-1. The purpose of this project is to study individual and biological factors that interact with outcomes of short-term (acute) exercise in FM.

Method. A controlled prospective exercise study. Thirty women with FM and 30 healthy age-matched women, aged 20-50 years, will be recruited to the study. Two 15-minute ergometer bicycle exercise tests will be conducted in feasting patients, separated by one month. The first exercise test is at a low and the second at a high intensity. Measurements comprise blood test, pain rating and pain threshold, conducted before and after the test. The levels of IGF-1, IL-6 and IL-8 will be measured, and the changes in them will be related to health status and pain.


Study Type: Observational
Study Design: Observational Model: Case Control
Time Perspective: Prospective
Official Title: Acute Effects of Exercise in Women With FM

Resource links provided by NLM:

Further study details as provided by Göteborg University:

Primary Outcome Measures:
  • IGF1 level [ Time Frame: 15 min ] [ Designated as safety issue: No ]
    Ergometer cycle test of 15 minutes at low respective high intensity. Blood test is done before and after exercise. Change in quantity of IGF1 is measured.

Secondary Outcome Measures:
  • Pain rating [ Time Frame: 15 minutes ] [ Designated as safety issue: No ]
    Pain is rated by the test person before and after the ergometer cycle test.

  • Pain threshold [ Time Frame: 15 minutes ] [ Designated as safety issue: No ]
    Pain threshold is measured before and after the ergometer test.

  • Interleukin 6 and 8 [ Time Frame: 15 minutes ] [ Designated as safety issue: No ]
    Blood test is done before and after the ergometer bicycle test. Quantity of interleukin 6 and 8 is measured.

Biospecimen Retention:   Samples Without DNA
Blood serum

Estimated Enrollment: 60
Study Start Date: May 2012
Estimated Study Completion Date: December 2015
Estimated Primary Completion Date: December 2015 (Final data collection date for primary outcome measure)
Women with fibromyalgia, aged 20-50 years
Healthy controls
Women without severe disease, aged 20-50 years


Ages Eligible for Study:   20 Years to 50 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
The participants are recruited from previous studies.

Inclusion Criteria:

  • clinical diagnosis of fibromyalgia
  • age 20-50 years

Exclusion Criteria:

  • heart disease
  • neurological disease
  • severe osteoarthritis
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT01592916

Contact: Kaisa Mannerkorpi, Assoc prof 046-31-3424220

Sahlgrenska University Hospital, Dept of Physical Therapy Recruiting
Göteborg, Sweden, 41345
Contact: Kaisa E Mannerkorpi, Ass prof    0046-31-3421195   
Sponsors and Collaborators
Göteborg University
Sahlgrenska University Hospital, Sweden
The Swedish Research Council
Principal Investigator: Kaisa Mannerkorpi, Assoc prof Göteborg University
  More Information

No publications provided

Responsible Party: Göteborg University Identifier: NCT01592916     History of Changes
Other Study ID Numbers: GU-143-12
Study First Received: May 4, 2012
Last Updated: May 28, 2015
Health Authority: Sweden: The National Board of Health and Welfare

Keywords provided by Göteborg University:

Additional relevant MeSH terms:
Myofascial Pain Syndromes
Muscular Diseases
Musculoskeletal Diseases
Nervous System Diseases
Neuromuscular Diseases
Rheumatic Diseases processed this record on November 27, 2015