Clinical Trial: Physical Training in Patients With Idiopathic Inflammatory Myopathies

Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Interventional

Official Title: Physical Training in Patients With Idiopathic Inflammatory Myopathies

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 Summary: To assess the impact of 12-weeks of physical training in patients with idiopathic inflammatory myopathies.
Sponsor: University of Sao Paulo

Current Primary Outcome: Cardiopulmonary test [ Time Frame: 12 weeks ]

Original Primary Outcome: Same as current

Current Secondary Outcome:

• 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.

Original Secondary Outcome:

• 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.

Dates:
Date Received: March 9, 2017
Date Started: January 2017
Date Completion: January 2022
Last Updated: March 24, 2017
Last Verified: March 2017