Development of Treatments Aiming at Improvement of Functi... | NCT00545649

Studies
Development of Treatments Aiming at Improvement of Function in Patients With Chronic Widespread Pain

NCT00545649

Sponsor

Göteborg University

Status

Completed

Last Update Posted

Oct 17, 2007Estimated

Enrollment

164Actual

Phase

Not Applicable

Conditions

Fibromyalgia

Interventions

Exercise and education
Education

Countries

Sweden

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Sep 2007

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

May 2004

Primary Completion Date

Not provided

Completion Date

Mar 2007Actual

First Submitted Date

Oct 16, 2007

First Submission Date that Met QC Criteria

Oct 16, 2007

First Posted Date

Oct 17, 2007Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Oct 16, 2007

Last Update Posted Date

Oct 17, 2007Estimated

Name	Class
The Swedish Research Council	OTHER_GOV

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

164 patients with fibromyalgia and chronic widespread pain were randomized to an exercise-education group or to education-only group. The study period was 20 week. The primary outcome measures comprised the six-minute walk test and the Fibromyalgia Impact Questionnaire. Several other self-administered instruments were included.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

164Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
1	Experimental	Exercise and education	Behavioral: Exercise and education
2	Active Comparator	Education only	Behavioral: Education

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Exercise and education	Behavioral		1
Education

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Body function (he six-minute walk test) and health status (the Fibromyalgia Impact Questionnaire)		2004-2007

Secondary Outcomes

Measure	Description	Time Frame
Self-administered questionnaires assessing distress, stress, quality of life, physical activity, fatigue		2004-2007

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

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

Exclusion Criteria:

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

Accepts Healthy Volunteers

Sex

Female

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

60 Years

Standard Ages

Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
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

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Alingsas Primary Health Care		Alingsås			Sweden
Göteborg Primary Health Care

Condition Browse Module

MeSH Terms

ID	Term
D005356	Fibromyalgia
D059350	Chronic Pain
D009043	Motor Activity

Ancestor Terms

ID	Term
D009135	Muscular Diseases
D009140	Musculoskeletal Diseases
D012216	Rheumatic Diseases
D009468	Neuromuscular Diseases

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D015444	Exercise
D004522	Educational Status

Ancestor Terms

ID	Term
D009043	Motor Activity
D009068	Movement
D009142	Musculoskeletal Physiological Phenomena
D055687	Musculoskeletal and Neural Physiological Phenomena

Browse Leaves

Not provided

Browse Branches

Not provided