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

NCT ID: NCT01278641

Last Updated: 2011-01-19

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

44 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-01-31

Study Completion Date

2009-11-30

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.

Conditions

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Fibromyalgia Pain

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Investigators

Study Groups

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1

Intervention i arm 1 comprises graded strength resistance training, 75 minutes twice a week for 12 weeks.

Group Type EXPERIMENTAL

Graded strength resistance training program

Intervention Type BEHAVIORAL

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

2

Intervention in arm 2 comprises low intensive temperate pool exercise 50 minutes, twice a week for 12 weeks.

Group Type EXPERIMENTAL

Temperate pool exercise program

Intervention Type BEHAVIORAL

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

3

Reference group, continues with normal activities during the study period of 12 weeks.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Graded strength resistance training program

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

Intervention Type BEHAVIORAL

Temperate pool exercise program

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

Intervention Type BEHAVIORAL

Eligibility Criteria

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Inclusion Criteria

Male patients with Fibromyalgia or Chronic Widespread pain

Exclusion Criteria

Other severe physical or psychiatric disorders.
Minimum Eligible Age

18 Years

Maximum Eligible Age

60 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

No

Sponsors

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Göteborg University

OTHER

Sponsor Role lead

Responsible Party

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Göteborg University, Dep of Rheumatology

Principal Investigators

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Kaisa E Mannerkorpi, Ass Prof

Role: PRINCIPAL_INVESTIGATOR

Göteborg University, Dept of Rheumatology

Locations

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Sjukgymnastik Primärvård Rosenhäll

Uddevalla, , Sweden

Site Status

Countries

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Sweden

References

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Ericsson A, Bremell T, Cider A, Mannerkorpi K. Effects of exercise on fatigue and physical capacity in men with chronic widespread pain - a pilot study. BMC Sports Sci Med Rehabil. 2016 Sep 6;8(1):29. doi: 10.1186/s13102-016-0054-9. eCollection 2016.

Reference Type DERIVED
PMID: 27602228 (View on PubMed)

Other Identifiers

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082-07

Identifier Type: -

Identifier Source: org_study_id

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