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Completed

NCT Number: NCT03092167

Physical Training in Patients With Idiopathic Inflammatory Myopathies

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Samuel Katsuyuki Shinjo

São Paulo, 01246903, Brazil

About this study

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

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Physical exercises

Other

Physical exercises

Primary outcomes

  1. 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.

Secondary outcomes

  1. 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.

  2. 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).

  3. 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)

  4. 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.

  5. 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).

  6. 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.

  7. Health Assessment Questionnaire

    Time frame: 12 weeks

    Especific questionnaire (health assessment questionnaire). Pontuaction 0.00-3.00

  8. 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.

  9. 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.

  10. 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.

Sponsors and collaborators

Lead sponsor

University of Sao Paulo

Other

Registry information

Important dates

Study start
2017
Primary completion
2021
Study completion
2021
First posted
Mar 27, 2017
Registry last updated
Apr 30, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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