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Trial record 1 of 1 for:    NCT01226784
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The Effects of Training and Relaxation on Fibromyalgia.

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ClinicalTrials.gov Identifier: NCT01226784
Recruitment Status : Completed
First Posted : October 22, 2010
Last Update Posted : October 27, 2020
Sponsor:
Collaborators:
Sahlgrenska University Hospital, Sweden
University Hospital, Linkoeping
Information provided by (Responsible Party):
Eva Kosek, Karolinska Institutet

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

Condition or disease Intervention/treatment Phase
Fibromyalgia Behavioral: Physcial activity Not Applicable

Detailed Description:

A multi-center trial examining the effects of progressive resistance group exercise compared with an active control group (relaxation). A person-centred model of exercise was used. The intervention was performed twice a week for 15 weeks and was supervised by experienced physiotherapists.

Secondary aims off this multi-center study was to improve the understanding of pain mechanisms in fibromyalgia and how these are affected by physical exercise. Please see references of published articles for details.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 240 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
Official Title: The Effects of Training and Relaxation on Fibromyalgia.
Actual Study Start Date : October 2010
Actual Primary Completion Date : May 2015
Actual Study Completion Date : October 2020

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: Physcial exercise
15 weeks of progressive resistance group exercise, twice/week supervised by physical therapist
Behavioral: Physcial activity
Strenght training Relaxation exercise

Active Comparator: Relaxation exercise
15 weeks of relaxation exercise, twice/week supervised by physical therapist
Behavioral: Physcial activity
Strenght training Relaxation exercise




Primary Outcome Measures :
  1. Muscle function [ Time Frame: 2010-2013 ]
    isometric knee-extension force (Steve Strong®)


Secondary Outcome Measures :
  1. Fibromyalgia impact questionnaire [ Time Frame: 2010-2013 ]
    Ratings on FIQ, total score

  2. VAS pain [ Time Frame: 2010-2013 ]
    Pain intensity ratings on VAS



Information from the National Library of Medicine

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Ages Eligible for Study:   20 Years to 65 Years   (Adult, Older Adult)
Sexes 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

-


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01226784


Locations
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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
Publications:

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Responsible Party: Eva Kosek, Professor, Karolinska Institutet
ClinicalTrials.gov Identifier: NCT01226784    
Other Study ID Numbers: RF 2010 stud GLS
First Posted: October 22, 2010    Key Record Dates
Last Update Posted: October 27, 2020
Last Verified: October 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by Eva Kosek, Karolinska Institutet:
Strength exercise
Physical exercise
Physiotheraphy
Additional relevant MeSH terms:
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Fibromyalgia
Myofascial Pain Syndromes
Muscular Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Neuromuscular Diseases
Nervous System Diseases