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Idiopathic Inflammatory MyopathiesNCT03092167

Physical Training in Patients With Idiopathic Inflammatory Myopathies

A study testing Physical exercises in people with Idiopathic Inflammatory Myopathies and Physical Activity, run by University of Sao Paulo at 1 site in Brazil.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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. Read more about this study

Who is it for?
Ages 18 years and olderHealthy volunteers can take part
What is being tested?
Physical exercises
Could I receive a placebo?
No, everyone receives an active treatment
How many people
12 participants
Where
1 siteBrazil
Study dates
Jan 2017to 29 Apr 2021
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

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

Trial locations and contacts

1 site in 1 country.

Brazil1 site

  • Samuel Katsuyuki Shinjo

    São Paulo, 01246903

Other trials in Brazil

About this study

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.

Read the detailed description

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

Being tested
Physical exercises
Medical subject headings
Myositis, Motor Activity

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Physical exercisesOther

    Physical exercises

Study groups in NCT03092167
Study groupRoleWhat they receive
CaseActive comparatorPatients: this group will be submitted to 12-weeks, twice/week, physical exercises.
Receives: Other: Physical exercises
ControlNo interventionPatients: this group will not be submitted to 12-weeks, twice/week, physical exercises.
Healthy controlNo interventionVolunteers: this group will not be submitted to 12-weeks, twice/week, physical exercises.

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: 12 weeks

Secondary outcomes (10)

  1. 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.

    Measured: 12 weeks

  2. Strength muscle tests

    The dynamic 1-RM for the leg-press and the bench-press exercises, arm curl (with the dominant arm).

    Measured: 12 weeks

  3. 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)

    Measured: 12 weeks

  4. 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.

    Measured: 12 weeks

  5. 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).

    Measured: 12 weeks

  6. 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.

    Measured: 12 weeks

  7. Health Assessment Questionnaire

    Especific questionnaire (health assessment questionnaire). Pontuaction 0.00-3.00

    Measured: 12 weeks

  8. 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.

    Measured: 12 weeks

  9. 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.

    Measured: 12 weeks

  10. 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.

    Measured: 12 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted27 Mar 2017
  2. Study startJan 2017
  3. Primary completion29 Apr 2021
  4. Study completion29 Apr 2021

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Basic science
Allocation
Non-randomised
Intervention model
Parallel groups
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)
Enrolment
12 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03092167
Sponsor's protocol ID
MYO-HCFMUSP-02
Status last verified
Apr 2021
First submitted
9 Mar 2017
Last updated
30 Apr 2021
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • 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.

    PubMed 34227790

Questions about this trial

What is this clinical trial studying?

A study testing Physical exercises in people with Idiopathic Inflammatory Myopathies and Physical Activity, run by University of Sao Paulo at 1 site in Brazil.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 30 Apr 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Brazil. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Cardiopulmonary test (time frame: 12 weeks). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03092167, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Apr 2021.

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