Acute Effects of Exercise in Women With Fibromyalgia (FM)

This study is currently recruiting participants. (see Contacts and Locations)
Verified June 2014 by Göteborg University
Sponsor:
Collaborators:
Sahlgrenska University Hospital, Sweden
The Swedish Research Council
Information provided by (Responsible Party):
Göteborg University
ClinicalTrials.gov Identifier:
NCT01592916
First received: May 4, 2012
Last updated: June 25, 2014
Last verified: June 2014
  Purpose

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
Fibromyalgia

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: October 2014
Estimated Primary Completion Date: September 2014 (Final data collection date for primary outcome measure)
Groups/Cohorts
Fibromyalgia
Women with fibromyalgia, aged 20-50 years
Healthy controls
Women without severe disease, aged 20-50 years

  Eligibility

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.

Criteria

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 ClinicalTrials.gov identifier: NCT01592916

Contacts
Contact: Kaisa Mannerkorpi, Assoc prof 046-31-3424220 kaisa.mannerkorpi@rheuma.gu.se

Locations
Sweden
Sahlgrenska University Hospital, Dept of Physical Therapy Recruiting
Göteborg, Sweden, 41345
Contact: Kaisa E Mannerkorpi, Ass prof    0046-31-3421195    kaisa.mannerkorpi@rheuma.gu.se   
Sponsors and Collaborators
Göteborg University
Sahlgrenska University Hospital, Sweden
The Swedish Research Council
Investigators
Principal Investigator: Kaisa Mannerkorpi, Assoc prof Göteborg University
  More Information

No publications provided

Responsible Party: Göteborg University
ClinicalTrials.gov Identifier: NCT01592916     History of Changes
Other Study ID Numbers: GU-143-12
Study First Received: May 4, 2012
Last Updated: June 25, 2014
Health Authority: Sweden: The National Board of Health and Welfare

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

ClinicalTrials.gov processed this record on July 28, 2014