Physical Training in Patients With Idiopathic Inflammatory Myopathies

Study Overview
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Brief Summary
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Physical training may improve physical capacity and health parameters in various systemic autoimmune diseases, including idiopathic inflammatory myopathies. Therefore, the present study will assess the role of an exercise training program in patients with idiopathic inflammatory myopathies.

Detailed Description
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To assess the impact of 12-weeks of physical training in patients with idiopathic inflammatory myopathies.

Official Title
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Physical Training in Patients With Idiopathic Inflammatory Myopathies

Conditions
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Idiopathic Inflammatory Myopathies, Physical Activity

Intervention / Treatment
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* Other: Physical exercises


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Diagnosis of DM / PM according to the criteria of Bohan and Peter (1975) Both genders and age ≥ 18 years Use of prednisone ≤ 0.5 mg/kg/day in the last three months. The dose of prednisone will be kept fixed throughout the study Physically inactive Exclusion Criteria: Disease relapsing Neoplasia associated-myositis Overlapping myositis Use of lipid-lowering drugs Smoking Diabetes mellitus

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Basic Science
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: 15 idiopathic inflammatory myopathies submmited to physical exercises 15 idiopathic inflammatory myopathies not submmited to physcial exercises 10 healthy individuals
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Case<br>Patients: this group will be submitted to 12-weeks, twice/week, physical exercises. | Other: Physical exercises<br>* Physical exercises<br>|
| No Intervention: Control<br>Patients: this group will not be submitted to 12-weeks, twice/week, physical exercises. | |
| No Intervention: Healthy control<br>Volunteers: this group will not be submitted to 12-weeks, twice/week, physical exercises. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Cardiopulmonary test | Patients will undertake a maximal graded exercise test on a treadmill, with increments in velocity and grade at every minute until volitional exhaustion. VO2peak will be considered as the average of the final 30 s of the test. Ventilatory threshold (VAT) will be determined when ventilatory equivalent for VO2 (VE/VO2) increased without a concomitant increase in ventilatory equivalent for carbon dioxide (VE/VCO2). Respiratory compensation point (RCP) will be determined when VE/VO2 and VE/VCO2 increased simultaneously. | 12 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Serum cytokines | Blood samples will be centrifuged at 3000 rpm for 15 min at 4°C, and the serum aliquot will be stored at -80°C for subsequent analyses. Cytokines (i.e., IL-6, TNF alpha, IFN gamma) will be measured using a multiplex human panel (Milliplex Map, Millipore, Billerica, MA, USA). Data analysis will be performed through Luminex xMAP Technology, according to the manufacturer's instructions. | 12 weeks | 
| Strength muscle tests | The dynamic 1-RM for the leg-press and the bench-press exercises, arm curl (with the dominant arm). | 12 weeks | 
| Muscle biopsies | After local anesthesia, a cutaneous incision will be made in lateral thigh face. The biopsy will be done using the Bergstrom needle. Histological (hematoxylin and eosin)/immunohistochemical (CD4, CD8, CD68, CD20, C5b-9, MHCI, MHCII, CD31) analysis will be performed in muscle samples (at baseline and after 12 weeks) in all patients (present study) | 12 weeks | 
| Functional muscle tests | Isometric strength (assessed by handgrip, with the dominant arm) will be assessed at baseline and after the intervention. Muscle function will be evaluated through the TUG and the TST tests. | 12 weeks | 
| Myositis Disease Activity Assessment Tool | This partially validated tool measures the degree of disease activity of extra-muscular organ systems and muscle. This is a combined tool that includes the Myositis Disease Activity Assessment Visual Analogue Scales (MYOACT), which is a series of physician's assessments of disease activity, and the Myositis Intention to Treat Activity Index (MITAX). | 12 weeks | 
| Muscle enzymes | This partially validated tool measures the serum activities of at least 2 of the 4 muscle-associated enzymes including creatine phosphokinase (CK), the transaminases (ALT, AST), lactate dehydrogenase (LD) and aldolase. | 12 weeks | 
| Health Assessment Questionnaire | Especific questionnaire (health assessment questionnaire). Pontuaction 0.00-3.00 | 12 weeks | 
| Manual Muscle Testing | This partially validated tool assesses muscle strength using manual muscle testing (MMT). A 0 - 10 point scale is proposed for use. An abbreviated group of 8 proximal, distal, and axial muscles performs similarly to a total of 24 muscle groups, and is also proposed for use for research studies. | 12 weeks | 
| Patient/Parent Global Activity | This partially validated tool measures the global evaluation by the patient, or by the parent if the patient is a minor, of the patient's overall disease activity at the time of assessment using a 10 cm. visual analogue scale. | 12 weeks | 
| Physician Global Activity | This partially validated tool measures the global evaluation by the treating physician of the overall disease activity of the patient at the time of assessment using a 10 cm. visual analogue scale and a 5 point Likert scale. | 12 weeks |