The effect of physical activity interventions on inflammatory muscle disorders

Not Applicable

Completed

• Conditions: Idiopathic inflammatory myopathies/myositis; Musculoskeletal Diseases; Myositis

• Registration Number: ISRCTN35925199
• Lead Sponsor: Revmatologický ústav

Brief Summary

2021 Results article in https://pubmed.ncbi.nlm.nih.gov/34154634/ (added 24/06/2021) 2022 Results article in https://pubmed.ncbi.nlm.nih.gov/36232755/ (added 14/06/2023)

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Completion: 2017-06-30
• Study Start: 2020-05-22
• Last Update Posted: 26 June 2023

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 52

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

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

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
1. Muscle endurance assessed by FI-2 test (Functional Index-2)<br>2. Muscle strength assessed by MMT8 test (Manual Muscle Testing-8)<br><br>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 Outcome Measures

Name	Time	Method
1. Health/disability assessed using HAQ questionnaire (Health Assessment Questionnaire)<br>2. Quality of life assessed using SF-36 questionnaire (Medical Outcomes Short Form-36)<br>3. Fatigue assessed using FIS questionnaire (Fatigue Impact Scale)<br>4. Depression assessed using BDI-II questionnaire (Beck´s Depression Inventory-II)<br>5. Stability assessed by stabilometry - vector trace area<br>6. Body composition assessed by bioelectric impedance (BIA-2000-M) and densitometry (iDXA Lunar)<br>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<br><br>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)