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NCT Number: NCT01278641

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.

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Key information

Conditions

Fibromyalgia Behavior Fatigue Motor Activity Muscular Diseases Musculoskeletal Diseases Nervous System Diseases Neurologic Manifestations Neuromuscular Diseases Pain Pathological Conditions, Signs and Symptoms Rheumatic Diseases Signs and Symptoms

Age range

18 year–60 year

Sex eligibility

Male

Study type

Interventional

Phase

Not applicable

Primary location

Sjukgymnastik Primärvård Rosenhäll

Uddevalla, 451 34, Sweden

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

Male patients with Fibromyalgia or Chronic Widespread pain

Exclusion criteria

Other severe physical or psychiatric disorders.

Treatment and study plan

Graded strength resistance training program

Behavioral

Graded strength resistance training, 75 minutes, twice a week for 12 weeks.

Temperate pool exercise program

Behavioral

Temperate pool low intensive exercise, 50 minutes, twice a week for 12 weeks.

Primary outcomes

  1. The multidimensional Fatigue Inventory (MFI-20)

    Time frame: 12 weeks

Secondary outcomes

  1. The Hospital Anxiety and Depression Scale (HADS)

    Time frame: 12 weeks

  2. Muscle strength (measured with Isobex and Steve Strong)

    Time frame: 12 weeks

Sponsors and collaborators

Lead sponsor

Göteborg University

Other

Registry information

Important dates

Study start
2008
Primary completion
2009
Study completion
2009
First posted
Jan 19, 2011
Registry last updated
Jan 19, 2011

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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