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A longitudinal, integrated clinical, histological and mRNA profiling study of resistance exercise in myositis

Study Title:

A longitudinal, integrated clinical, histological and mRNA profiling study of resistance exercise in myositis

 

Principal Investigator:

Ingrid Lundberg, MD, PhD

 

Study Hypothesis:

Resistance exercise should improve strength in patients with polymyositis or dernatomyositis

 

Study Design:

Open label

 

Types & Number of IIM Studied:

9 patients with adult dermatomyositis or polymyositis

 

Entry Criteria:

a) Diagnosis of definite or probable PM or DM according to the Bohan and Peter criteria (Bohan 1975 part 1), b) Disease duration > 12 months, c) Unchanged disease activity according to the physicians judgement and d) Stable medication for three months. Exclusion criteria were: a) Diagnosis of inclusion body myositis (IBM), b) Comorbidities preventing vigorous exercise, c) Severe osteoporosis, d) Active malignant disease, and e) Doing exercise more than once a week

 

IMACS Core Set Measures Included:

Physician Global Activity-VAS, Patient Global Activity-VAS, Muscle Strength Testing-MMT, Functional Assessment Tools-HAQ, Laboratory-Muscle Enzymes, Extramuscular Assessment-Myositis Disease Activity Assessment Tool (MDAAT)

 

Other Measures Included:

10 VRM, Funtional Index-2, Grip strength, The Borg CR-10 scale, The Myositis Activities Profile (MAP)

 

Primary Outcome:

Improvement criteria were set to 20% or more for at least two of the variables 10 VRM, the FI-2 and the Grippit.

 

Secondary Outcomes:

MAP, Disease activity, gene expression profiles in muscle tissue, maximal oxygen uptake

 

Key Trial Dates:

Completed and Published

 

Funding Sources:

Supported by the Vårdal Foundation, The Swedish Rheumatism Association, Swedish Research Council 2001-74-X14045, Gustaf V:th 80-year Foundation, Professor Nanna Svartz Foundation, Magnus Bergvalls stiftelse, Stiftelsen Clas Groschinskys Minnesfond, and Karolinska Institutet Foundation.

 

Contact:

Ingrid Lundberg, M.D., Ph.D.
Rheumatology Unit
Department of Medicine
Karolinska University Hospital
SE- 171 76 Stockholm, Sweden
Tel +46-8-5177-6087
Fax +46-8-5177-3080

 

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