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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00519103
First Posted: August 21, 2007
Last Update Posted: August 30, 2007
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
Children's Research Institute
Information provided by:
Karolinska Institutet
  Purpose
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 Intervention
Myositis Exercise Other: exercise

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science

Resource links provided by NLM:


Further study details as provided by Karolinska Institutet:

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 ]

Enrollment: 8
Study Start Date: December 2002
Study Completion Date: March 2003
Arms Assigned Interventions
Experimental: 1
Active resistive excercise for 7 weeks
Other: exercise

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
  Eligibility

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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Senior)
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
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): 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 Submitted: August 20, 2007
First Posted: August 21, 2007
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