Idiopathic inflammatory myopathies/myositis Musculoskeletal Diseases Myositis
Conditions
Interventions
Patients are allocated into the intervention or control group based on their willingness to adhere to the schedule.
Control group: standard of care (i.e. standard pharmacological treatment according
Sponsors
Revmatologický ústav
Eligibility
Sex/Gender
All
Age
18 Years to 110 Years
Inclusion criteria
Inclusion criteria: 1. An Independent Ethics Committee approved written Informed Consent form is signed and dated by the subject 2. Participant is considered reliable and capable of adhering to the protocol and visit schedule 3. Participant is male or female at least 18 years of age 4. Participant fulfilled the Bohan/Peter 1975 criteria (for polymyositis and dermatomyositis) or the ENMC 2004 criteria (for immune-mediated necrotizing myopathy) 5. Participant must have a weakness of proximal muscle groups 6. Participant is regularly followed at our out-patient department and adheres to the standard-of-care pharmacological therapy indicated by his treating rheumatologist 7. Participant is willing to participate in the study and undergo all planned examinations
Exclusion criteria
Exclusion criteria: Participant has any other condition, including medical or psychiatric, which in the investigator's judgment would make the subject unsuitable for inclusion in the study
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1. Muscle endurance assessed by FI-2 test (Functional Index-2) 2. Muscle strength assessed by MMT8 test (Manual Muscle Testing-8) Measured at baseline (i.e. week 0, before the start of the study), week 12 (i.e. after half of the 6-month intervention), week 24 (i.e. after the end of the 6-month intervention), and week 48 (i.e. after the end of a 6-month follow-up) | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Health/disability assessed using HAQ questionnaire (Health Assessment Questionnaire) 2. Quality of life assessed using SF-36 questionnaire (Medical Outcomes Short Form-36) 3. Fatigue assessed using FIS questionnaire (Fatigue Impact Scale) 4. Depression assessed using BDI-II questionnaire (Beck´s Depression Inventory-II) 5. Stability assessed by stabilometry - vector trace area 6. Body composition assessed by bioelectric impedance (BIA-2000-M) and densitometry (iDXA Lunar) 7. Safety assessed using local (in the muscle biopsy samples extracted before the start and after the end of the intervention program) and systemic expression of selected inflammatory markers Measured at baseline (i.e. week 0, before the start of the study), week 12 (i.e. after half of the 6-month intervention), week 24 (i.e. after the end of the 6-month intervention), and week 48 (i.e. after the end of a 6-month follow-up) | — |
Countries
Czech Republic
Outcome results
None listed