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Completed

NCT Number: NCT00519103

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

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

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Key information

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Rheumatology unit, Karolinska Unirversity hospital

Stockholm, Sweden

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Exercise

Other

Primary outcomes

  1. effects of physical exercise muscle strength and function in patients with chronic polymyositis or dermatomyositis

    Time frame: 7weeks

Secondary outcomes

  1. 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

Sponsors and collaborators

Lead sponsor

Karolinska Institutet

Other

Collaborators

  • Children's National Research Institute

Registry information

Important dates

Study start
2002
Study completion
2003
First posted
Aug 21, 2007
Registry last updated
Aug 30, 2007

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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