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

Primary Purpose

Myositis, Exercise

Status
Completed
Phase
Not Applicable
Locations
Sweden
Study Type
Interventional
Intervention
exercise
Sponsored by
Karolinska Institutet
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Myositis focused on measuring microarray, Inflammtion, fibrosis

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Rheumatology unit, Karolinska Unirversity hospital

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

1

Arm Description

Active resistive excercise for 7 weeks

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

effects of exercise on gene expression and corresponding protein expression in muscle tissue and on signs of inflammation in peripheral blood

Full Information

First Posted
August 20, 2007
Last Updated
August 29, 2007
Sponsor
Karolinska Institutet
Collaborators
Children's National Research Institute
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1. Study Identification

Unique Protocol Identification Number
NCT00519103
Brief Title
Resistance Exercise Reduces the Expression of Inflammation and Fibrosis Associated Genes in Autoimmune Myositis Patients
Study Type
Interventional

2. Study Status

Record Verification Date
August 2007
Overall Recruitment Status
Completed
Study Start Date
December 2002 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
March 2003 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Karolinska Institutet
Collaborators
Children's National Research Institute

4. Oversight

Data Monitoring Committee
No

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Myositis, Exercise
Keywords
microarray, Inflammtion, fibrosis

7. Study Design

Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
8 (Actual)

8. Arms, Groups, and Interventions

Arm Title
1
Arm Type
Experimental
Arm Description
Active resistive excercise for 7 weeks
Intervention Type
Other
Intervention Name(s)
exercise
Primary Outcome Measure Information:
Title
effects of physical exercise muscle strength and function in patients with chronic polymyositis or dermatomyositis
Time Frame
7weeks
Secondary Outcome Measure Information:
Title
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ingrid E Lundberg, MD, PhD
Organizational Affiliation
Rheumatology Unit, Department of Medicine, in Solna, Karolinska Institutet
Official's Role
Principal Investigator
Facility Information:
Facility Name
Rheumatology unit, Karolinska Unirversity hospital
City
Stockholm
Country
Sweden

12. IPD Sharing Statement

Learn more about this trial

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

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