Acute Effects of Exercise in Women With Fibromyalgia (FM)

Fibromyalgia Clinical Trial

Official title:

Acute Effects of Exercise in Women With FM

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01592916
• Other study ID #: GU-143-12
• Status: Completed
• Phase: N/A
• First received: May 4, 2012
• Last updated: February 1, 2018
• Start date: May 10, 2012
• Est. completion date: November 23, 2012

Study information

• Verified date: February 2018
• Source: Göteborg University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 55
• Est. completion date: November 23, 2012
• Est. primary completion date: November 23, 2012
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 20 Years to 50 Years

Eligibility

Inclusion Criteria:

• clinical diagnosis of fibromyalgia

• age 20-50 years

Exclusion Criteria:

• heart disease

• neurological disease

• severe osteoarthritis

Related Conditions & MeSH terms

• Fibromyalgia
• Myofascial Pain Syndromes

Locations

Country	Name	City	State
Sweden	Sahlgrenska University Hospital, Dept of Physical Therapy	Göteborg

Sponsors (3)

Lead Sponsor	Collaborator
Göteborg University	Sahlgrenska University Hospital, Sweden, The Swedish Research Council

Country where clinical trial is conducted

Sweden, 

References & Publications (1)

Mannerkorpi K, Landin-Wilhelmsen K, Larsson A, Cider Å, 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/s128 — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Pain rating	Pain is rated by the test person before and after the ergometer cycle test.	15 minutes
Secondary	Pain threshold	Pain threshold is measured before and after the ergometer test.	15 minutes
Secondary	Interleukin 6 and 8	Blood test is done before and after the ergometer bicycle test. Quantity of interleukin 6 and 8 is measured.	15 minutes