Acute Effects of Exercise in Women With Fibromyalgia (FM)

This study is currently recruiting participants.
Verified November 2013 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: November 25, 2013
Last verified: November 2013
  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
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: November 25, 2013
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 April 15, 2014