Physical Training in Patients With Idiopathic Inflammatory Myopathies

Physical Activity Clinical Trial

Official title:

Physical Training in Patients With Idiopathic Inflammatory Myopathies

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03092167
• Other study ID #: MYO-HCFMUSP-02
• Status: Completed
• Phase: N/A
• Start date: January 2017
• Est. completion date: April 29, 2021

Study information

• Verified date: April 2021
• Source: University of Sao Paulo
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Description:

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 12
• Est. completion date: April 29, 2021
• Est. primary completion date: April 29, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Idiopathic Inflammatory Myopathies
• Muscular Diseases
• Myositis
• Physical Activity

Intervention

Other:
• Physical exercises
Physical exercises

Locations

Country	Name	City	State
Brazil	Samuel Katsuyuki Shinjo	Sao Paulo

Sponsors (1)

Lead Sponsor	Collaborator
University of Sao Paulo

Country where clinical trial is conducted

Brazil, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Cardiopulmonary test	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.	12 weeks
Secondary	Serum cytokines	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.	12 weeks
Secondary	Strength muscle tests	The dynamic 1-RM for the leg-press and the bench-press exercises, arm curl (with the dominant arm).	12 weeks
Secondary	Muscle biopsies	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)	12 weeks
Secondary	Functional muscle tests	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.	12 weeks
Secondary	Myositis Disease Activity Assessment Tool	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).	12 weeks
Secondary	Muscle enzymes	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.	12 weeks
Secondary	Health Assessment Questionnaire	Especific questionnaire (health assessment questionnaire). Pontuaction 0.00-3.00	12 weeks
Secondary	Manual Muscle Testing	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.	12 weeks
Secondary	Patient/Parent Global Activity	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.	12 weeks
Secondary	Physician Global Activity	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.	12 weeks