Physical Training in Patients With Idiopathic Inflammatory Myopathies
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|ClinicalTrials.gov Identifier: NCT03092167|
Recruitment Status : Recruiting
First Posted : March 27, 2017
Last Update Posted : May 10, 2018
|Condition or disease||Intervention/treatment||Phase|
|Idiopathic Inflammatory Myopathies Physical Activity||Other: Physical exercises||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||40 participants|
|Intervention Model:||Parallel Assignment|
|Intervention 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)|
|Masking Description:||Open label|
|Primary Purpose:||Basic Science|
|Official Title:||Physical Training in Patients With Idiopathic Inflammatory Myopathies|
|Actual Study Start Date :||January 2017|
|Estimated Primary Completion Date :||January 2022|
|Estimated Study Completion Date :||January 2022|
Active Comparator: Case
Patients: this group will be submitted to 12-weeks, twice/week, physical exercises.
Other: Physical exercises
No Intervention: Control
Patients: this group will not be submitted to 12-weeks, twice/week, physical exercises.
No Intervention: Healthy control
Volunteers: this group will not be submitted to 12-weeks, twice/week, physical exercises.
- Cardiopulmonary test [ Time Frame: 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.
- Serum cytokines [ Time Frame: 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.
- Strength muscle tests [ Time Frame: 12 weeks ]The dynamic 1-RM for the leg-press and the bench-press exercises, arm curl (with the dominant arm).
- Muscle biopsies [ Time Frame: 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)
- Functional muscle tests [ Time Frame: 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.
- Myositis Disease Activity Assessment Tool [ Time Frame: 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 [ Time Frame: 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.
- Health Assessment Questionnaire [ Time Frame: 12 weeks ]Especific questionnaire (health assessment questionnaire). Pontuaction 0.00-3.00
- Manual Muscle Testing [ Time Frame: 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.
- Patient/Parent Global Activity [ Time Frame: 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.
- Physician Global Activity [ Time Frame: 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.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03092167
|Contact: Samuel K Shinjo, PhDfirstname.lastname@example.org|
|Samuel Katsuyuki Shinjo||Recruiting|
|Sao Paulo, Brazil, 01246903|
|Contact: Samuel K Shinjo, PhD 55-11-3061-7176 email@example.com|
|Sub-Investigator: Diego S Oliveira|
|Sub-Investigator: Isabela BP Borges|
|Sub-Investigator: Marilda G Silva|
|Sub-Investigator: Rafael G Misse|
|Sub-Investigator: Leticia A Perin|
|Sub-Investigator: Alexandre M Santos|
|Sub-Investigator: Samara F Alves|
|Principal Investigator:||Samuel K Shinjo, PhD||Universidade de Sao Paulo - Rheumatology Division|