Resistance Exercise Reduces the Expression of Inflammation and Fibrosis Associated Genes in Autoimmune Myositis Patients

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ClinicalTrials.gov Identifier: NCT00519103

Recruitment Status : Completed

First Posted : August 21, 2007

Last Update Posted : August 30, 2007

Sponsor:

Collaborator:

Children's Research Institute

Information provided by:

Karolinska Institutet

Study Description

Brief Summary:

The aim of this study was to investigate the effects of physical exercise on gene expression in muscle biopsies from patients with chronic polymyositis or dermatomyositis

Condition or disease	Intervention/treatment	Phase
Myositis Exercise	Other: exercise	Not Applicable

Detailed Description:

Eight patients with polymyositis or dermatomyositis according to the Bohan and Peter criteria and who had all participated in a resistive exercise trial at Karolinska University Hospital, Stockholm, Sweden, were included in this study. Patients were included if they had a disease duration more than 12 months and they had to have a stable, low disease activity and medication for three months before enrollment in the study. Patients with inclusion body myositis were excluded as well as patients with co morbidities that contradicted vigorous exercise (severe osteoporosis with multiple fractures, malignant disease severe lung disease) or if they were physically active more than once a week. The median disease duration at time of study start was 4.5 years (range 2,7-29 year). All patients had been treated with glucocorticoids and other immunosuppressive therapies with some improvement of muscle function but with persisting muscle impairment. At time of study seven patients were still on immunosuppressive treatment, five were taking prednisone with a median dosage of 2.5 mg/day (range 0-6.25 mg/d). Six patients were treated with azathioprine, one in combination with cyclosporine A, one patient was treated with methotrexate and one with IVIG 2g/kg body weight every three months

Study Design


Study Type :	Interventional (Clinical Trial)
Actual Enrollment :	8 participants
Intervention Model:	Single Group Assignment
Masking:	None (Open Label)
Primary Purpose:	Basic Science
Study Start Date :	December 2002
Actual Study Completion Date :	March 2003

Resource links provided by the National Library of Medicine

Genetics Home Reference related topics: Idiopathic inflammatory myopathy

MedlinePlus related topics: Exercise and Physical Fitness Genes and Gene Therapy Myositis

Genetic and Rare Diseases Information Center resources: Idiopathic Inflammatory Myopathy

U.S. FDA Resources

Arms and Interventions

Arm	Intervention/treatment
Experimental: 1 Active resistive excercise for 7 weeks	Other: exercise

Outcome Measures

Primary Outcome Measures :

effects of physical exercise muscle strength and function in patients with chronic polymyositis or dermatomyositis [ Time Frame: 7weeks ]

Secondary Outcome Measures :

effects of exercise on gene expression and corresponding protein expression in muscle tissue and on signs of inflammation in peripheral blood [ Time Frame: 7 weeks ]

Eligibility Criteria

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Ages Eligible for Study:	18 Years to 80 Years (Adult, Older Adult)
Sexes Eligible for Study:	All
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Patients were included if they had a disease duration more than 12 months and they had to have a stable, low disease activity and medication for three months before enrollment in the study

Exclusion Criteria:

Patients with inclusion body myositis were excluded as well as patients with co morbidities that contradicted vigorous exercise (severe osteoporosis with multiple fractures, malignant disease severe lung disease) or if they were physically active more than once a week.

Contacts and Locations

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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): NCT00519103

Locations


Sweden
Rheumatology unit, Karolinska Unirversity hospital
Stockholm, Sweden

Sponsors and Collaborators

Karolinska Institutet

Children's Research Institute

Investigators


Principal Investigator:	Ingrid E Lundberg, MD, PhD	Rheumatology Unit, Department of Medicine, in Solna, Karolinska Institutet

More Information


ClinicalTrials.gov Identifier:	NCT00519103 History of Changes
Other Study ID Numbers:	Lundberg-1
First Posted:	August 21, 2007 Key Record Dates
Last Update Posted:	August 30, 2007
Last Verified:	August 2007

Keywords provided by Karolinska Institutet:


microarray Inflammtion fibrosis

Additional relevant MeSH terms:


Myositis Muscular Diseases Musculoskeletal Diseases Neuromuscular Diseases Nervous System Diseases

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