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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 : November 19, 2018
Sponsor:
Information provided by (Responsible Party):
Samuel Katsuyuki Shinjo, PhD, University of Sao Paulo

March 9, 2017
March 27, 2017
November 19, 2018
January 2017
January 2022   (Final data collection date for primary outcome measure)
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.
Same as current
Complete list of historical versions of study NCT03092167 on ClinicalTrials.gov Archive Site
  • 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.
  • 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 (vastus laterallis muscle) [ 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/immunohistochemical analysis will be performed in muscle samples.
  • 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.
  • Extramuscular Assessment - 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).
  • Laboratory - 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.
  • Functional Assessment Tools - HAQ [ Time Frame: 12 weeks ]
    Especific questionnaire (health assessment questionnaire). Pontuaction 0.00-3.00
  • Muscle Strength Testing - Manual Muscle Testing (MMT) [ 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 - Visual Analogue Scale/Likert [ 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 - Visual Analogue Scale/Likert [ 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.
Not Provided
Not Provided
 
Physical Training in Patients With Idiopathic Inflammatory Myopathies
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.
To assess the impact of 12-weeks of physical training in patients with idiopathic inflammatory myopathies.
Interventional
Not Applicable
Allocation: Non-Randomized
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
  • Idiopathic Inflammatory Myopathies
  • Physical Activity
Other: Physical exercises
Physical exercises
  • Active Comparator: Case
    Patients: this group will be submitted to 12-weeks, twice/week, physical exercises.
    Intervention: 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.
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
40
Same as current
January 2022
January 2022   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: All
18 Years and older   (Adult, Older Adult)
Yes
Contact: Samuel K Shinjo, PhD 55-11-3061-7176 samuel.shinjo@gmail.com
Brazil
 
 
NCT03092167
MYO-HCFMUSP-02
Yes
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Plan to Share IPD: No
Samuel Katsuyuki Shinjo, PhD, University of Sao Paulo
University of Sao Paulo
Not Provided
Principal Investigator: Samuel K Shinjo, PhD Universidade de Sao Paulo - Rheumatology Division
University of Sao Paulo
November 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP