Men With Fibromyalgia or Chronic Widespread Pain - Effect of Exercise on Symptoms and Body Functions

January 18, 2011 updated by: Göteborg University

A controlled randomised trial (CRT). 60 men who fulfil the ACR-criteria for Fibromyalgia or Chronic Widespread Pain (Wolfe 1990) participate in the study.

The main objective of the study is to compare the effect of a graded strength training program and a low intensive pool exercise program.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

A controlled randomised trial (CRT). 60 men who fulfil the ACR-criteria for Fibromyalgia or Chronic Widespread Pain (Wolfe 1990) participate in the study.

40 patients (in the city Uddevalla) are randomised into two groups; low intensive temperate pool exercise program, and graded strength training program. The study period is 12 weeks.

20 patients (in the city Alingsås) make a reference group who is asked to continue their normal activities during the study period.

Primary outcomes are fatigue (using the Multidimensional fatigue inventory and VAS for global fatigue)and muscle strength (using Steve Strong, Isobex and the Grippit). Several other self-administered instruments was used.

Study Type

Interventional

Enrollment (Actual)

44

Phase

  • Not Applicable

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
      • Uddevalla, Sweden, 451 34
        • Sjukgymnastik Primärvård Rosenhäll

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 60 years (ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Male

Description

Inclusion Criteria:

Male patients with Fibromyalgia or Chronic Widespread pain

Exclusion Criteria:

Other severe physical or psychiatric disorders.

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

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: SINGLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: 1
Intervention i arm 1 comprises graded strength resistance training, 75 minutes twice a week for 12 weeks.
Behavioral: Graded strength resistance training program
Graded strength resistance training, 75 minutes, twice a week for 12 weeks.
EXPERIMENTAL: 2
Intervention in arm 2 comprises low intensive temperate pool exercise 50 minutes, twice a week for 12 weeks.
Behavioral: Temperate pool exercise program
Temperate pool low intensive exercise, 50 minutes, twice a week for 12 weeks.
NO_INTERVENTION: 3
Reference group, continues with normal activities during the study period of 12 weeks.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
The multidimensional Fatigue Inventory (MFI-20)
Time Frame: 12 weeks
12 weeks

Secondary Outcome Measures

Outcome Measure
Time Frame
The Hospital Anxiety and Depression Scale (HADS)
Time Frame: 12 weeks
12 weeks
Muscle strength (measured with Isobex and Steve Strong)
Time Frame: 12 weeks
12 weeks

Collaborators and Investigators

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

Sponsor

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

January 1, 2008

Primary Completion (ACTUAL)

March 1, 2009

Study Completion (ACTUAL)

November 1, 2009

Study Registration Dates

First Submitted

January 18, 2011

First Submitted That Met QC Criteria

January 18, 2011

First Posted (ESTIMATE)

January 19, 2011

Study Record Updates

Last Update Posted (ESTIMATE)

January 19, 2011

Last Update Submitted That Met QC Criteria

January 18, 2011

Last Verified

April 1, 2008

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 082-07

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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