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The Effects of Training and Relaxation on Fibromyalgia.

This study is enrolling participants by invitation only.
Sponsor:
Collaborators:
Sahlgrenska University Hospital, Sweden
University Hospital, Linkoeping
Information provided by:
Karolinska Institutet
ClinicalTrials.gov Identifier:
NCT01226784
First received: October 21, 2010
Last updated: NA
Last verified: October 2010
History: No changes posted
  Purpose

Effects of physical training and relaxation exercise on pathophysiological mechanisms and symptoms in finbromyalgia patients.


Condition Intervention
Fibromyalgia
 Behavioral: Physcial activity

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Basic Science

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Karolinska Institutet:

Primary Outcome Measures:
  • Muscle function [ Time Frame: 2010-2013 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Fibromyalgia impact questionnaire [ Time Frame: 2010-2013 ] [ Designated as safety issue: No ]
  • VAS pain [ Time Frame: 2010-2013 ] [ Designated as safety issue: No ]

Estimated Enrollment: 240
Study Start Date: October 2010
Estimated Primary Completion Date: October 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Physcial exercise Behavioral: Physcial activity
Strenght training Relaxation exercise
Active Comparator: Relaxation exercise Behavioral: Physcial activity
Strenght training Relaxation exercise

  Eligibility

Ages Eligible for Study:   20 Years to 65 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria: ACR 1990 criteria for fibromyalgia -

Exclusion Criteria: Other dominating pain condition, severe disease preventing from participating in physical exercise

-

  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01226784

Locations
Sweden
Sahlgrenska University Hospital
Gothenburg, Sweden, 41 345
Linkopings University Hospital
Linkoping, Sweden, 581 85
Karolinska Institute
Stockholm, Sweden, 171 77
Sponsors and Collaborators
Karolinska Institutet
Sahlgrenska University Hospital, Sweden
University Hospital, Linkoeping
  More Information

No publications provided

Responsible Party: Eva Kosek, Karolinska Institute
ClinicalTrials.gov Identifier: NCT01226784     History of Changes
Other Study ID Numbers: RF 2010 stud GLS
Study First Received: October 21, 2010
Last Updated: October 21, 2010
Health Authority: Sweden: Karolinska Institute

Additional relevant MeSH terms:
Fibromyalgia
Myofascial Pain Syndromes
Muscular Diseases
Musculoskeletal Diseases
 Rheumatic Diseases
Neuromuscular Diseases
Nervous System Diseases

ClinicalTrials.gov processed this record on May 23, 2013