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

Exercise Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00519103
• Other study ID #: Lundberg-1
• Status: Completed
• Phase: N/A
• First received: August 20, 2007
• Last updated: August 29, 2007
• Start date: December 2002
• Est. completion date: March 2003

Study information

• Verified date: August 2007
• Source: Karolinska Institutet
• Contact: n/a
• Is FDA regulated: No
• Health authority: Sweden: Institutional Review Board
• Study type: Interventional

Clinical Trial 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

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 8
• Est. completion date: March 2003
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 80 Years

Eligibility

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.

Study Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Basic Science

Related Conditions & MeSH terms

• Exercise
• Myositis

Intervention

Other:
• exercise

Locations

Country	Name	City	State
Sweden	Rheumatology unit, Karolinska Unirversity hospital	Stockholm

Sponsors (2)

Lead Sponsor	Collaborator
Karolinska Institutet	Children's Research Institute

Country where clinical trial is conducted

Sweden, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	effects of physical exercise muscle strength and function in patients with chronic polymyositis or dermatomyositis		7weeks
Secondary	effects of exercise on gene expression and corresponding protein expression in muscle tissue and on signs of inflammation in peripheral blood		7 weeks