NCT00643006

Brief Summary

The study aims to compare low-intensive and high-intensive physical exercise and its impact on physical function, pain and signs of inflammation.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
67

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jan 2008

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

January 1, 2008

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

March 19, 2008

Completed
6 days until next milestone

First Posted

Study publicly available on registry

March 25, 2008

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2009

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2009

Completed
3.4 years until next milestone

Results Posted

Study results publicly available

October 30, 2012

Completed
Last Updated

October 30, 2012

Status Verified

September 1, 2012

Enrollment Period

1.3 years

First QC Date

March 19, 2008

Results QC Date

May 3, 2012

Last Update Submit

September 28, 2012

Conditions

Exercise TherapyPain

Keywords

FibromyalgiaPhysical activityFunctionPainExerciseInflammation

Outcome Measures

Primary Outcomes (2)

  • Six-minute Walk Test

    Patient is instructed to walk as fast as she can. The distance covered during 6 minutes is documented.

    15 weeks

  • Change of Pain Level From Baseline.

    Pain was measured by The Fibromyalgia Impact Questionnaire (FIQ) subscale for Pain, which is a self-rated pain on visual analogue scale, 0-100 mm. The higher value, the worse pain.

    15 weeks

Study Arms (2)

A. High intensive exercise

EXPERIMENTAL

High intensive exercise

Behavioral: Physical exercise

B. Low-intensive exercise

ACTIVE COMPARATOR

Low-to-moderate intensive supervised walks

Behavioral: Active comparator: low intensive exercise

Interventions

Physical exerciseBEHAVIORAL

Supervised walks with poles twice a week at moderate-high intensity

A. High intensive exercise
Active comparator: low intensive exerciseBEHAVIORAL

Supervised walks once a week at low-intensity.

B. Low-intensive exercise

Eligibility Criteria

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

You may qualify if:

  • Women with Fibromyalgia, interested in exercise twice a week

You may not qualify if:

  • Other severe diseases

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

Alingsås Primary Health Care

Alingsås, Sweden

Location

Sahlgrenska University Hospital, Dept of Physical Therapy

Gothenburg, 41345, Sweden

Location

Uddevalla Primary Health Care

Uddevalla, Sweden

Location

Related Publications (3)

  • Bjersing JL, Erlandsson M, Bokarewa MI, Mannerkorpi K. Exercise and obesity in fibromyalgia: beneficial roles of IGF-1 and resistin? Arthritis Res Ther. 2013 Feb 27;15(1):R34. doi: 10.1186/ar4187.

    PMID: 23446104DERIVED

  • Bjersing JL, Dehlin M, Erlandsson M, Bokarewa MI, Mannerkorpi K. Changes in pain and insulin-like growth factor 1 in fibromyalgia during exercise: the involvement of cerebrospinal inflammatory factors and neuropeptides. Arthritis Res Ther. 2012 Jul 9;14(4):R162. doi: 10.1186/ar3902.

    PMID: 22776095DERIVED

  • Mannerkorpi K, Nordeman L, Cider A, Jonsson G. Does moderate-to-high intensity Nordic walking improve functional capacity and pain in fibromyalgia? A prospective randomized controlled trial. Arthritis Res Ther. 2010;12(5):R189. doi: 10.1186/ar3159. Epub 2010 Oct 13.

    PMID: 20942911DERIVED

MeSH Terms

Conditions

PainFibromyalgiaMotor ActivityInflammation

Interventions

Exercise

Condition Hierarchy (Ancestors)

Neurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and SymptomsMuscular DiseasesMusculoskeletal DiseasesRheumatic DiseasesNeuromuscular DiseasesNervous System DiseasesBehaviorPathologic Processes

Intervention Hierarchy (Ancestors)

Motor ActivityMovementMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological Phenomena

Results Point of Contact

Title
Dr. K Mannerkorpi
Organization
Gothenburg University
kaisa.mannerkorpi@rheuma.gu.se
046-31-24220

Study Officials

  • Kaisa E Mannerkorpi, Ass prof

    Göteborg University, Dept of Rheumatology

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
Yes
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 19, 2008

First Posted

March 25, 2008

Study Start

January 1, 2008

Primary Completion

May 1, 2009

Study Completion

June 1, 2009

Last Updated

October 30, 2012

Results First Posted

October 30, 2012

Record last verified: 2012-09

Locations

SE(3)