Acute Effects of Exercise in Women With Fibromyalgia (FM)
1 other identifier
observational
55
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for all trials
Started May 2012
Shorter than P25 for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
May 4, 2012
CompletedFirst Posted
Study publicly available on registry
May 7, 2012
CompletedStudy Start
First participant enrolled
May 10, 2012
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 23, 2012
CompletedStudy Completion
Last participant's last visit for all outcomes
November 23, 2012
CompletedFebruary 5, 2018
February 1, 2018
7 months
May 4, 2012
February 1, 2018
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
IGF1 level
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.
15 min
Secondary Outcomes (3)
Pain rating
15 minutes
Pain threshold
15 minutes
Interleukin 6 and 8
15 minutes
Study Arms (2)
Fibromyalgia
Women with fibromyalgia, aged 20-50 years
Healthy controls
Women without severe disease, aged 20-50 years
Eligibility Criteria
The participants are recruited from previous studies.
You may qualify if:
- clinical diagnosis of fibromyalgia
- age 20-50 years
You may not qualify if:
- heart disease
- neurological disease
- severe osteoarthritis
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Göteborg Universitylead
- Sahlgrenska University Hospitalcollaborator
- The Swedish Research Councilcollaborator
Study Sites (1)
Sahlgrenska University Hospital, Dept of Physical Therapy
Gothenburg, 41345, Sweden
Related Publications (1)
Mannerkorpi K, Landin-Wilhelmsen K, Larsson A, Cider A, Arodell O, Bjersing JL. Acute effects of physical exercise on the serum insulin-like growth factor system in women with fibromyalgia. BMC Musculoskelet Disord. 2017 Jan 25;18(1):37. doi: 10.1186/s12891-017-1402-y.
PMID: 28122522RESULT
Biospecimen
Blood serum
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Kaisa Mannerkorpi, Assoc prof
Göteborg University
Study Design
- Study Type
- observational
- Observational Model
- CASE CONTROL
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
May 4, 2012
First Posted
May 7, 2012
Study Start
May 10, 2012
Primary Completion
November 23, 2012
Study Completion
November 23, 2012
Last Updated
February 5, 2018
Record last verified: 2018-02