NCT00545649

Brief Summary

The study aims to evaluate the effects of adding supervised exercise in supplement to an educational self-management program, and to determine which subgroups would gain effects of the treatment.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
164

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started May 2004

Typical duration for not_applicable

Geographic Reach
1 country

3 active sites

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

May 1, 2004

Completed
2.8 years until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2007

Completed
8 months until next milestone

First Submitted

Initial submission to the registry

October 16, 2007

Completed
1 day until next milestone

First Posted

Study publicly available on registry

October 17, 2007

Completed
Last Updated

October 17, 2007

Status Verified

September 1, 2007

First QC Date

October 16, 2007

Last Update Submit

October 16, 2007

Conditions

Fibromyalgia

Keywords

Fibromyalgiachronic painphysicalexerciseactivityeducation

Outcome Measures

Primary Outcomes (1)

  • Body function (he six-minute walk test) and health status (the Fibromyalgia Impact Questionnaire)

    2004-2007

Secondary Outcomes (1)

  • Self-administered questionnaires assessing distress, stress, quality of life, physical activity, fatigue

    2004-2007

Study Arms (2)

1

EXPERIMENTAL

Exercise and education

Behavioral: Exercise and education

2

ACTIVE COMPARATOR

Education only

Behavioral: Education

Interventions

Exercise and educationBEHAVIORAL
1
EducationBEHAVIORAL
2

Eligibility Criteria

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

You may qualify if:

  • Women with Fibromyalgia or Chronic widespread pain, aged from 18 to 60 years.

You may not qualify if:

  • Other somatic or psychiatric disorders, inability to understand Swedish, allergy to chlorine, ongoing treatments or plans to start other treatments during the study period

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

Alingsas Primary Health Care

Alingsås, Sweden

Location

Göteborg Primary Health Care

Gothenburg, Sweden

Location

Uddevalla Primary Health Care

Uddevalla, Sweden

Location

MeSH Terms

Conditions

FibromyalgiaChronic PainMotor Activity

Interventions

ExerciseEducational Status

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Motor ActivityMovementMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological PhenomenaSocioeconomic FactorsPopulation Characteristics

Study Officials

  • Kaisa Mannerkorpi, Ass prof

    Göteborg University, Institute of Medicine, Department of Rheumatology and Inflammation Research

    PRINCIPAL INVESTIGATOR

  • Kaisa Mannerkorpi, Ass prof

    Göteborg University, Institute of Medicine, Department of Rheumtology and Inflammation Research

    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

October 16, 2007

First Posted

October 17, 2007

Study Start

May 1, 2004

Study Completion

March 1, 2007

Last Updated

October 17, 2007

Record last verified: 2007-09

Locations

SE(3)