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

This study has been completed.
Sponsor:
Information provided by:
Göteborg University
ClinicalTrials.gov Identifier:
NCT01278641
First received: January 18, 2011
Last updated: NA
Last verified: April 2008
History: No changes posted
  Purpose

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.


Condition Intervention
Fibromyalgia
Pain
 Behavioral: Graded strength resistance training program
Behavioral: Temperate pool exercise program

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single Blind (Investigator)
Primary Purpose: Treatment
Official Title: Men With Fibromyalgia or Chronic Widespread Pain - Effect of Exercise on Symptoms and Body Functions

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Göteborg University:

Primary Outcome Measures:
  • The multidimensional Fatigue Inventory (MFI-20) [ Time Frame: 12 weeks ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • The Hospital Anxiety and Depression Scale (HADS) [ Time Frame: 12 weeks ] [ Designated as safety issue: Yes ]
  • Muscle strength (measured with Isobex and Steve Strong) [ Time Frame: 12 weeks ] [ Designated as safety issue: Yes ]

Enrollment: 44
Study Start Date: January 2008
Study Completion Date: November 2009
Primary Completion Date: March 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

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.

  Eligibility

Ages Eligible for Study:   18 Years to 60 Years
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

Male patients with Fibromyalgia or Chronic Widespread pain

Exclusion Criteria:

Other severe physical or psychiatric disorders.

  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01278641

Locations
Sweden
Sjukgymnastik Primärvård Rosenhäll
Uddevalla, Sweden, 451 34
Sponsors and Collaborators
Göteborg University
Investigators
Principal Investigator: Kaisa E Mannerkorpi, Ass Prof Göteborg University, Dept of Rheumatology
  More Information

No publications provided

Responsible Party: Kaisa Mannerkorpi, Associate professor, Göteborg University, Dep of Rheumatology
ClinicalTrials.gov Identifier: NCT01278641     History of Changes
Other Study ID Numbers: 082-07
Study First Received: January 18, 2011
Last Updated: January 18, 2011
Health Authority: Sweden: Regional Ethical Review Board

Keywords provided by Göteborg University:
Fibromyalgia
Widespread pain
Fatigue
Physical exercise

Additional relevant MeSH terms:
Fibromyalgia
Myofascial Pain Syndromes
Muscular Diseases
Musculoskeletal Diseases
 Rheumatic Diseases
Neuromuscular Diseases
Nervous System Diseases

ClinicalTrials.gov processed this record on May 21, 2013