Physical Training in Patients With Idiopathic Inflammatory Myopathies

NCT ID: NCT03092167

Last Updated: 2021-04-30

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

12 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-01-31

Study Completion Date

2021-04-29

Brief Summary

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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 Description

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

Conditions

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Idiopathic Inflammatory Myopathies Physical Activity

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

15 idiopathic inflammatory myopathies submmited to physical exercises 15 idiopathic inflammatory myopathies not submmited to physcial exercises 10 healthy individuals
Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

NONE

Open label

Study Groups

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Case

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

Group Type ACTIVE_COMPARATOR

Physical exercises

Intervention Type OTHER

Physical exercises

Control

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

Group Type NO_INTERVENTION

No interventions assigned to this group

Healthy control

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

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Physical exercises

Physical exercises

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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University of Sao Paulo

OTHER

Sponsor Role lead

Responsible Party

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Samuel Katsuyuki Shinjo, PhD

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Samuel K Shinjo, PhD

Role: PRINCIPAL_INVESTIGATOR

Universidade de Sao Paulo - Rheumatology Division

Locations

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Samuel Katsuyuki Shinjo

São Paulo, , Brazil

Site Status

Countries

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Brazil

References

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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.

Reference Type DERIVED
PMID: 34227790 (View on PubMed)

Other Identifiers

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MYO-HCFMUSP-02

Identifier Type: -

Identifier Source: org_study_id

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