Clinical trial NCT00519103: Resistance Exercise Reduces the Expression of Inflammation and Fibrosis Associated Genes in Autoimmune Myositis Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Myositis
Exercise
Keywords: microarray
Inflammtion
fibrosis
Lead sponsor: Karolinska Institutet
Sponsor class: OTHER
Collaborators: name: Children's National Research Institute
First posted: 2007-08-21
Enrollment: 8
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: BASIC_SCIENCE

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

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 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.

Primary outcomes:
measure: effects of physical exercise muscle strength and function in patients with chronic polymyositis or dermatomyositis
timeFrame: 7weeks
Secondary outcomes:
measure: effects of exercise on gene expression and corresponding protein expression in muscle tissue and on signs of inflammation in peripheral blood
timeFrame: 7 weeks
Other outcomes:
Locations:
city: Stockholm
country: Sweden
facility: Rheumatology unit, Karolinska Unirversity hospital
Study officials:
affiliation: Rheumatology Unit, Department of Medicine, in Solna, Karolinska Institutet
name: Ingrid E Lundberg, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: