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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 : March 28, 2017
Sponsor:
Information provided by (Responsible Party):

Study Description
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.

Condition or disease Intervention/treatment
Idiopathic Inflammatory Myopathies Physical Activity Other: Physical exercises

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

Study Design

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 40 participants
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
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


Arms and Interventions

Arm Intervention/treatment
Active Comparator: Case
Patients: this group will be submitted to 12-weeks, twice/week, physical exercises.
Other: Physical exercises
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.


Outcome Measures

Primary Outcome Measures :
  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 Outcome Measures :
  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.


Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03092167


Contacts
Contact: Samuel K Shinjo, PhD 55-11-3061-7176 samuel.shinjo@gmail.com

Locations
Brazil
Samuel Katsuyuki Shinjo Recruiting
Sao Paulo, Brazil, 01246903
Contact: Samuel K Shinjo, PhD    55-11-3061-7176    samuel.shinjo@gmail.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         
Sponsors and Collaborators
University of Sao Paulo
Investigators
Principal Investigator: Samuel K Shinjo, PhD Universidade de Sao Paulo - Rheumatology Division
More Information

Responsible Party: Samuel Katsuyuki Shinjo, PhD, Principal Investigator, University of Sao Paulo
ClinicalTrials.gov Identifier: NCT03092167     History of Changes
Other Study ID Numbers: MYO-HCFMUSP-02
First Posted: March 27, 2017    Key Record Dates
Last Update Posted: March 28, 2017
Last Verified: March 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
Muscular Diseases
Myositis
Musculoskeletal Diseases
Neuromuscular Diseases
Nervous System Diseases