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

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

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

Conditions
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Pain, Fibromyalgia

Intervention / Treatment
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* Behavioral: Graded strength resistance training program
* Behavioral: Temperate pool exercise program


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Male patients with Fibromyalgia or Chronic Widespread pain Exclusion Criteria: Other severe physical or psychiatric disorders.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 60 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br>Intervention i arm 1 comprises graded strength resistance training, 75 minutes twice a week for 12 weeks. | Behavioral: Graded strength resistance training program<br>* Graded strength resistance training, 75 minutes, twice a week for 12 weeks.<br>|
| Experimental: 2<br>Intervention in arm 2 comprises low intensive temperate pool exercise 50 minutes, twice a week for 12 weeks. | Behavioral: Temperate pool exercise program<br>* Temperate pool low intensive exercise, 50 minutes, twice a week for 12 weeks.<br>|
| No Intervention: 3<br>Reference group, continues with normal activities during the study period of 12 weeks. | |

What is the study measuring?
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Primary Outcome Measures

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

Secondary Outcome Measures

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

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Fibromyalgia, Widespread pain, Fatigue, Physical exercise