Acute Effects of Exercise in Women With Fibromyalgia (FM)
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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 |
- 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.
- 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: | May 2013 |
| Estimated Primary Completion Date: | May 2013 (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 |
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| Contact: Kaisa Mannerkorpi, Assoc prof | 046-31-3424220 | kaisa.mannerkorpi@rheuma.gu.se |
| 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 | |
| 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 5, 2012 |
| 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 May 21, 2013