NCT01278641

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
44

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jan 2008

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2008

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2009

Completed
8 months until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2009

Completed
1.2 years until next milestone

First Submitted

Initial submission to the registry

January 18, 2011

Completed
1 day until next milestone

First Posted

Study publicly available on registry

January 19, 2011

Completed
Last Updated

January 19, 2011

Status Verified

April 1, 2008

Enrollment Period

1.2 years

First QC Date

January 18, 2011

Last Update Submit

January 18, 2011

Conditions

FibromyalgiaPain

Keywords

FibromyalgiaWidespread painFatiguePhysical exercise

Outcome Measures

Primary Outcomes (1)

  • The multidimensional Fatigue Inventory (MFI-20)

    12 weeks

Secondary Outcomes (2)

  • The Hospital Anxiety and Depression Scale (HADS)

    12 weeks

  • Muscle strength (measured with Isobex and Steve Strong)

    12 weeks

Study Arms (3)

1

EXPERIMENTAL

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

Behavioral: Graded strength resistance training program

2

EXPERIMENTAL

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

Behavioral: Temperate pool exercise program

3

NO INTERVENTION

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

Interventions

Graded strength resistance training programBEHAVIORAL

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

1
Temperate pool exercise programBEHAVIORAL

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

2

Eligibility Criteria

Age18 Years - 60 Years
Sexmale
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Male patients with Fibromyalgia or Chronic Widespread pain

You may not qualify if:

  • Other severe physical or psychiatric disorders.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Sjukgymnastik Primärvård Rosenhäll

Uddevalla, 451 34, Sweden

Location

Related Publications (1)

  • 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.

    PMID: 27602228DERIVED

MeSH Terms

Conditions

FibromyalgiaPainFatigueMotor Activity

Condition Hierarchy (Ancestors)

Muscular DiseasesMusculoskeletal DiseasesRheumatic DiseasesNeuromuscular DiseasesNervous System DiseasesNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and SymptomsBehavior

Study Officials

  • Kaisa E Mannerkorpi, Ass Prof

    Göteborg University, Dept of Rheumatology

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

January 18, 2011

First Posted

January 19, 2011

Study Start

January 1, 2008

Primary Completion

March 1, 2009

Study Completion

November 1, 2009

Last Updated

January 19, 2011

Record last verified: 2008-04

Locations

SE(1)