Physical Training in Patients With Idiopathic Inflammatory Myopathies

Not Applicable

Completed

• Conditions: Idiopathic Inflammatory Myopathies; Physical Activity
• Interventions: Other: Physical exercises

• Registration Number: NCT03092167
• Lead Sponsor: University of Sao Paulo

Brief Summary

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

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

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study Start: 2017-01
• Study First Submitted: 2017-03-09
• Study First Submitted QC: 2017-03-21
• Study First Posted: 2017-03-27
• Status Verified: 2021-04
• Primary Completion: 2021-04-29
• Study Completion: 2021-04-29
• Last Update Submitted: 2021-04-29
• Last Update Posted: 2021-04-30

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 12

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

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Exclusion Criteria

• Disease relapsing
• Neoplasia associated-myositis
• Overlapping myositis
• Use of lipid-lowering drugs
• Smoking
• Diabetes mellitus

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Case	Physical exercises	Patients: this group will be submitted to 12-weeks, twice/week, physical exercises.

Primary Outcome Measures

Name	Time	Method
Cardiopulmonary test	12 weeks	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.

Secondary Outcome Measures

Name	Time	Method
Functional muscle tests	12 weeks	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.
Strength muscle tests	12 weeks	The dynamic 1-RM for the leg-press and the bench-press exercises, arm curl (with the dominant arm).
Patient/Parent Global Activity	12 weeks	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.
Serum cytokines	12 weeks	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.
Health Assessment Questionnaire	12 weeks	Especific questionnaire (health assessment questionnaire). Pontuaction 0.00-3.00
Muscle biopsies	12 weeks	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)
Myositis Disease Activity Assessment Tool	12 weeks	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).
Muscle enzymes	12 weeks	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.
Manual Muscle Testing	12 weeks	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.
Physician Global Activity	12 weeks	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.

Trial Locations

Locations (1)

Samuel Katsuyuki Shinjo; 🇧🇷 Sao Paulo, Brazil