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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

January 18, 2011
January 18, 2011
January 2008
March 2009   (final data collection date for primary outcome measure)
The multidimensional Fatigue Inventory (MFI-20) [ Time Frame: 12 weeks ] [ Designated as safety issue: Yes ]
Same as current
No Changes Posted
  • 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 ]
Same as current
Not Provided
Not Provided
 
Men With Fibromyalgia or Chronic Widespread Pain - Effect of Exercise on Symptoms and Body Functions
Men With Fibromyalgia or Chronic Widespread Pain - Effect of Exercise on Symptoms and Body Functions

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.

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.
Interventional
Not Provided
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single Blind (Investigator)
Primary Purpose: Treatment
  • Fibromyalgia
  • Pain
  • Behavioral: Graded strength resistance training program
    Graded strength resistance training, 75 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.
  • Experimental: 1
    Intervention i arm 1 comprises graded strength resistance training, 75 minutes twice a week for 12 weeks.
    Intervention: Behavioral: Graded strength resistance training program
  • Experimental: 2
    Intervention in arm 2 comprises low intensive temperate pool exercise 50 minutes, twice a week for 12 weeks.
    Intervention: Behavioral: Temperate pool exercise program
  • No Intervention: 3
    Reference group, continues with normal activities during the study period of 12 weeks.
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
44
November 2009
March 2009   (final data collection date for primary outcome measure)

Inclusion Criteria:

Male patients with Fibromyalgia or Chronic Widespread pain

Exclusion Criteria:

Other severe physical or psychiatric disorders.
Male
18 Years to 60 Years
No
Contact information is only displayed when the study is recruiting subjects
Sweden
 
NCT01278641
082-07
No
Kaisa Mannerkorpi, Associate professor, Göteborg University, Dep of Rheumatology
Göteborg University
Not Provided
Principal Investigator: Kaisa E Mannerkorpi, Ass Prof Göteborg University, Dept of Rheumatology
Göteborg University
April 2008

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP