Physical Training in Patients With Idiopathic Inflammatory Myopathies

NCT03092167 | Completed DMC

• 1 other identifier: MYO-HCFMUSP-02
• Study Type: interventional
• Target: 12
• Locations: 1 country
• Sites: 1

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.

Conditions

Idiopathic Inflammatory Myopathies; Physical Activity

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (10)

• Serum cytokines

  12 weeks

• Strength muscle tests

  12 weeks

• Muscle biopsies

  12 weeks

• Functional muscle tests

  12 weeks

• Myositis Disease Activity Assessment Tool

  12 weeks

Study Arms (3)

Case

ACTIVE COMPARATOR

Patients: this group will be submitted to 12-weeks, twice/week, physical exercises.

Other: Physical exercises

Control

NO INTERVENTION

Patients: this group will not be submitted to 12-weeks, twice/week, physical exercises.

Healthy control

NO INTERVENTION

Volunteers: this group will not be submitted to 12-weeks, twice/week, physical exercises.

Interventions

Physical exercises OTHER

Physical exercises

Case

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• Disease relapsing
• Neoplasia associated-myositis
• Overlapping myositis
• Use of lipid-lowering drugs
• Smoking
• Diabetes mellitus

Sponsors & Collaborators

• University of Sao Paulo: lead

Study Sites (1)

Samuel Katsuyuki Shinjo

São Paulo, 01246903, Brazil

Location

Related Publications (1)

• Borges IBP, de Oliveira DS, Marie SKN, Lenario AM, Oba-Shinjo SM, Shinjo SK. Exercise Training Attenuates Ubiquitin-Proteasome Pathway and Increases the Genes Related to Autophagy on the Skeletal Muscle of Patients With Inflammatory Myopathies. J Clin Rheumatol. 2021 Sep 1;27(6S):S224-S231. doi: 10.1097/RHU.0000000000001721.

  PMID: 34227790 DERIVED

MeSH Terms

Conditions

Myositis; Motor Activity

Interventions

Exercise

Condition Hierarchy (Ancestors)

Muscular Diseases; Musculoskeletal Diseases; Neuromuscular Diseases; Nervous System Diseases; Behavior

Intervention Hierarchy (Ancestors)

Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Study Officials

• Samuel K Shinjo, PhD

  Universidade de Sao Paulo - Rheumatology Division

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Masking Details: Open label
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: 15 idiopathic inflammatory myopathies submmited to physical exercises 15 idiopathic inflammatory myopathies not submmited to physcial exercises 10 healthy individuals

Study Record Dates

• First Submitted: March 9, 2017
• First Posted: March 27, 2017
• Study Start: January 1, 2017
• Primary Completion: April 29, 2021
• Study Completion: April 29, 2021
• Last Updated: April 30, 2021

Record last verified: 2021-04

Data Sharing

• IPD Sharing: Will not share

Locations

BR (1)