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

Primary Purpose

Fibromyalgia, Pain

Status

Completed

Phase

Not Applicable

Locations

Sweden

Study Type

Interventional

Intervention

Graded strength resistance training program

Temperate pool exercise program

About this trial

This is an interventional treatment trial for Fibromyalgia focused on measuring Fibromyalgia, Widespread pain, Fatigue, Physical exercise

Eligibility Criteria

18 Years - 60 Years (Adult)MaleDoes not accept healthy volunteers

Inclusion Criteria:

Male patients with Fibromyalgia or Chronic Widespread pain

Exclusion Criteria:

Other severe physical or psychiatric disorders.

Sites / Locations

Sjukgymnastik Primärvård Rosenhäll

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

No Intervention

Arm Label

Arm Description

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

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

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

Outcomes

Primary Outcome Measures

The multidimensional Fatigue Inventory (MFI-20)

Secondary Outcome Measures

The Hospital Anxiety and Depression Scale (HADS)

Muscle strength (measured with Isobex and Steve Strong)

Full Information

NCT ID

NCT01278641

First Posted

January 18, 2011

Last Updated

January 18, 2011

Sponsor

Göteborg University

1. Study Identification

Unique Protocol Identification Number

NCT01278641

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

April 2008

Overall Recruitment Status

Completed

Study Start Date

January 2008 (undefined)

Primary Completion Date

March 2009 (Actual)

Study Completion Date

November 2009 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor

Göteborg University

4. Oversight

Data Monitoring Committee

5. Study Description

Brief Summary

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

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Fibromyalgia, Pain

Keywords

Fibromyalgia, Widespread pain, Fatigue, Physical exercise

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

Investigator

Allocation

Randomized

Enrollment

44 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Arm Type

Experimental

Arm Description

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

Arm Title

Arm Type

Experimental

Arm Description

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

Arm Title

Arm Type

No Intervention

Arm Description

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

Intervention Type

Behavioral

Intervention Name(s)

Graded strength resistance training program

Intervention Description

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

Intervention Type

Behavioral

Intervention Name(s)

Temperate pool exercise program

Intervention Description

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

Primary Outcome Measure Information:

Title

The multidimensional Fatigue Inventory (MFI-20)

Time Frame

12 weeks

Secondary Outcome Measure Information:

Title

The Hospital Anxiety and Depression Scale (HADS)

Time Frame

12 weeks

Title

Muscle strength (measured with Isobex and Steve Strong)

Time Frame

12 weeks

10. Eligibility

Sex

Male

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

60 Years

Accepts Healthy Volunteers

Eligibility Criteria

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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Kaisa E Mannerkorpi, Ass Prof

Organizational Affiliation

Göteborg University, Dept of Rheumatology

Official's Role

Principal Investigator

Facility Information:

Facility Name

Sjukgymnastik Primärvård Rosenhäll

City

Uddevalla

ZIP/Postal Code

451 34

Country

Sweden

12. IPD Sharing Statement

Citations:

PubMed Identifier

27602228

Citation

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.

Results Reference

derived

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

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