Acute Effects of Exercise in Women With Fibromyalgia (FM)

February 1, 2018 updated by: Göteborg University

Acute Effects of Exercise in Women With 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.

Study Overview

Status

Completed

Conditions

Study Type

Observational

Enrollment (Actual)

55

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Sweden
      • Göteborg, Sweden, 41345
        • Sahlgrenska University Hospital, Dept of Physical Therapy

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 48 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Sampling Method

Non-Probability Sample

Study Population

The participants are recruited from previous studies.

Description

Inclusion Criteria:

  • clinical diagnosis of fibromyalgia
  • age 20-50 years

Exclusion Criteria:

  • heart disease
  • neurological disease
  • severe osteoarthritis

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Case-Control
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Fibromyalgia
Women with fibromyalgia, aged 20-50 years
Healthy controls
Women without severe disease, aged 20-50 years

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
15 min

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Pain rating
Time Frame: 15 minutes
Pain is rated by the test person before and after the ergometer cycle test.
15 minutes
Pain threshold
Time Frame: 15 minutes
Pain threshold is measured before and after the ergometer test.
15 minutes
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.
15 minutes

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Göteborg University

Collaborators

The Swedish Research Council
Sahlgrenska University Hospital, Sweden

Investigators

  • Principal Investigator: Kaisa Mannerkorpi, Assoc prof, Göteborg University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 10, 2012

Primary Completion (Actual)

November 23, 2012

Study Completion (Actual)

November 23, 2012

Study Registration Dates

First Submitted

May 4, 2012

First Submitted That Met QC Criteria

May 4, 2012

First Posted (Estimate)

May 7, 2012

Study Record Updates

Last Update Posted (Actual)

February 5, 2018

Last Update Submitted That Met QC Criteria

February 1, 2018

Last Verified

February 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • GU-143-12

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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