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NCT Number: NCT01592916

Acute Effects of Exercise in Women With Fibromyalgia (FM)

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.

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Key information

Conditions

Fibromyalgia Behavior Motor Activity Muscular Diseases Musculoskeletal Diseases Nervous System Diseases Neurologic Manifestations Neuromuscular Diseases Pain Pathological Conditions, Signs and Symptoms Rheumatic Diseases Signs and Symptoms

Age range

20 year–50 year

Sex eligibility

Female

Study type

Observational

Primary location

Sahlgrenska University Hospital, Dept of Physical Therapy

Gothenburg, 41345, Sweden

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • clinical diagnosis of fibromyalgia
  • age 20-50 years

Exclusion criteria

  • heart disease
  • neurological disease
  • severe osteoarthritis

Treatment and study plan

Primary outcomes

  1. IGF1 level

    Time frame: 15 min

    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 outcomes

  1. Pain rating

    Time frame: 15 minutes

    Pain is rated by the test person before and after the ergometer cycle test.

  2. Pain threshold

    Time frame: 15 minutes

    Pain threshold is measured before and after the ergometer test.

  3. Interleukin 6 and 8

    Time frame: 15 minutes

    Blood test is done before and after the ergometer bicycle test. Quantity of interleukin 6 and 8 is measured.

Sponsors and collaborators

Lead sponsor

Göteborg University

Other

Collaborators

  • Sahlgrenska University Hospital
  • The Swedish Research Council

Registry information

Official study title

Acute Effects of Exercise in Women With FM

Important dates

Study start
2012
Primary completion
2012
Study completion
2012
First posted
May 7, 2012
Registry last updated
Feb 5, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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