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

This study has been completed.
Sponsor:
Collaborator:
Children's Research Institute
Information provided by:
Karolinska Institutet
ClinicalTrials.gov Identifier:
NCT00519103
First received: August 20, 2007
Last updated: August 29, 2007
Last verified: August 2007
  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: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: 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

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

ClinicalTrials.gov Identifier: NCT00519103     History of Changes
Other Study ID Numbers: Lundberg-1
Study First Received: August 20, 2007
Last Updated: August 29, 2007
Health Authority: Sweden: Institutional Review Board

Keywords provided by Karolinska Institutet:
microarray
Inflammtion
fibrosis

Additional relevant MeSH terms:
Myositis
Muscular Diseases
Musculoskeletal Diseases
Neuromuscular Diseases
Nervous System Diseases

ClinicalTrials.gov processed this record on April 16, 2014