ClinicalTrials.gov
ClinicalTrials.gov Menu

Acute Effects of Exercise in Women With Fibromyalgia (FM)

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: NCT01592916
Recruitment Status : Completed
First Posted : May 7, 2012
Last Update Posted : February 2, 2018
Sponsor:
Collaborators:
Sahlgrenska University Hospital, Sweden
The Swedish Research Council
Information provided by (Responsible Party):
Göteborg University

Brief Summary:

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.


Condition or disease
Fibromyalgia

Study Type : Observational
Actual Enrollment : 55 participants
Observational Model: Case-Control
Time Perspective: Prospective
Official Title: Acute Effects of Exercise in Women With FM
Actual Study Start Date : May 10, 2012
Actual Primary Completion Date : November 23, 2012
Actual Study Completion Date : November 23, 2012

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Group/Cohort
Fibromyalgia
Women with fibromyalgia, aged 20-50 years
Healthy controls
Women without severe disease, aged 20-50 years



Primary Outcome Measures :
  1. IGF1 level [ Time Frame: 15 min ]
    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 :
  1. Pain rating [ Time Frame: 15 minutes ]
    Pain is rated by the test person before and after the ergometer cycle test.

  2. Pain threshold [ Time Frame: 15 minutes ]
    Pain threshold is measured before and after the ergometer test.

  3. Interleukin 6 and 8 [ Time Frame: 15 minutes ]
    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


Information from the National Library of Medicine

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, Learn About Clinical Studies.


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

Inclusion Criteria:

  • clinical diagnosis of fibromyalgia
  • age 20-50 years

Exclusion Criteria:

  • heart disease
  • neurological disease
  • severe osteoarthritis

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01592916


Locations
Sweden
Sahlgrenska University Hospital, Dept of Physical Therapy
Göteborg, Sweden, 41345
Sponsors and Collaborators
Göteborg University
Sahlgrenska University Hospital, Sweden
The Swedish Research Council
Investigators
Principal Investigator: Kaisa Mannerkorpi, Assoc prof Göteborg University

Publications of Results:
Responsible Party: Göteborg University
ClinicalTrials.gov Identifier: NCT01592916     History of Changes
Other Study ID Numbers: GU-143-12
First Posted: May 7, 2012    Key Record Dates
Last Update Posted: February 2, 2018
Last Verified: February 2018

Keywords provided by Göteborg University:
Fibromyalgia
Pain
Women
Exercise
IGF1

Additional relevant MeSH terms:
Fibromyalgia
Myofascial Pain Syndromes
Muscular Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Neuromuscular Diseases
Nervous System Diseases