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Idiopathic Inflammatory MyopathyNCT05027152

Muscle Function and Effects of Repetitive Task Training in Patients With Inflammatory Myopaties

A study testing Repetitive task training in people with Idiopathic Inflammatory Myopathy and Dermatomyositis, run by Federal University of Espirito Santo 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

Idiopathic inflammatory myopathies lead to important functional limitations resulting from the loss of muscle strength and endurance, especially in the hip and shoulder, which leads to a significant loss of quality of life for patients. Read more about this study

Who is it for?
Ages 18 years and olderHealthy volunteers can take part
What is being tested?
Repetitive task training
Could I receive a placebo?
No, everyone receives an active treatment
How many people
2 participants
Where
1 siteBrazil
Study dates
1 Sep 2021to 1 Sep 2023
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 polymyositis or dermatomyositis (Bohan and Peter criteria)
  • age ≥18 years
  • duration of disease since diagnosis for more than six months
  • stable medication ≥3 months
  • chronic inactive or mildly active but stable myositis for at least 3 months prior to observation
  • Health Assessment Questionnaire (HAQ) ≥0.5

Who cannot join

  • serious cardiac or pulmonary conditions
  • severe osteoporosis
  • unable to exercise
  • neoplasm
  • cognitive disorders
  • acute or chronic infection

Trial locations and contacts

1 site in 1 country.

Brazil1 site
  • Samira Tatiyama Miyamoto, PhD

    Vitória, Espírito Santo, 29050-780

Other trials in Brazil

About this study

Official title: Correlation of "Myositis Functional Index-3 (Fi-3)" With Muscle Function Assessed by Isokinetic Dynamometry and Effects of Repetitive Task Training in Patients With Inflammatory Myopaties

Idiopathic inflammatory myopathies lead to important functional limitations resulting from the loss of muscle strength and endurance, especially in the hip and shoulder, which leads to a significant loss of quality of life for patients. The aim of this study is to correlate the "Myositis Functional Index-3 (FI-3)" with muscle function assessed by computerized isokinetic dynamometry, electromyography and magnetic resonance through an observational study; and to study the effects of a repetitive task training program through an interventional study in patients with inflammatory myopathies. It is expected that FI-3 will present a good correlation with muscle function assessed by computerized isokinetic dynamometry and electromyography, given its reduced cost and less time spent on evaluation. It is also expected to demonstrate that repetitive task training is efficient and safe.

Read the detailed description

Idiopathic inflammatory myopathies lead to important functional limitations resulting from the loss of muscle strength and endurance, especially in the hip and shoulder, which leads to a significant loss of quality of life for patients. PURPOSE: to correlate the "Myositis Functional Index-3 (FI-3)" with muscle function assessed by computerized isokinetic dynamometry, electromyography and magnetic resonance through an observational study; and to compare the effects of a repetitive task training program with a resistance exercise program through an interventional study in patients with inflammatory myopathies. METHODS: this is an observational cross-sectional study for the observational study and an interventional study/randomized clinical trial for the interventional study. The study will be held at the Cassiano Antônio de Moraes University Hospital (HUCAM) and at the Interprofessional Health Clinic (CEIS) of the Federal University of Espírito Santo (UFES), located in the city of Vitória, Espírito Santo. Patients will come from the Rheumatology Service of HUCAM For the observational study, 30 patients with inflammatory myopathies and 15 healthy individuals matched for age and sex. For the interventional study, patients evaluated in the observational study will be invited to participate of the repetitive task training intervention. To participate in the research, patients must have a diagnosis of polymyositis or dermatomyositis (Bohan and Peter criteria); age ≥18 years; duration of disease since diagnosis for more than six months; stable medication ≥3 months; chronic inactive or mildly active but stable myositis for at least 3 months prior to observation; HAQ≥0.5. They may not have serious cardiac or pulmonary conditions; severe osteoporosis; unable to exercise; neoplasm; cognitive disorders; and acute or chronic infection. Healthy individuals must be age and sex matched with patients and may not have severe cardiac or pulmonary conditions; severe osteoporosis; unable to exercise; neoplasm; cognitive disorders; and acute or chronic infection. Patients will be evaluated in two moments: before starting the training programs and after 12 weeks. Healthy individuals will be evaluated only once. The data from the evaluations carried out before starting the training programs will be used for the analysis of the observational study. Participants will be evaluated for variables: muscle endurance (Functional Index-3 and isokinetic dynamometry), muscle strength (Manual Muscle Test 8 and isokinetic dynamometry), muscle activation (electromyography), muscle damage (magnetic resonance imaging of thigh muscles), cardiopulmonary capacity (6-minute walk test), pain (visual analogue scale), functional capacity (Health Assessment Questionnaire), quality of life (SF-36), disease activity (PGA, SGA, MDAAT, creatine phosphokinase and aldolase) and disease damage (MDI). In addition, demographic and clinical data such as date of birth, age, sex, self-reported race-color, marital status, occupational status, weight, height, date of first symptoms, date of diagnosis, comorbidities and medications in use will also be collected. The training program will last 12 weeks, twice a week in person with the supervision of physiotherapists and once a week at home. Each session will last 60 minutes. The repetitive task training group will carry out exercises involving upper and lower limbs. To determine the clinical-demographic characterization of the study population, descriptive statistics (mean and standard deviation) will be used; the correlation analysis will be performed using the Pearson or Spearman correlation coefficient; the comparison between the group of patients and the control group of healthy individuals will be performed using the t test or Mann-Whitney test; the normality test to be used will be the Shapiro-Wilk and the results will be considered significant for P<0.05. EXPECTED RESULTS: It is expected that FI-3 will present a good correlation with muscle function assessed by computerized isokinetic dynamometry and electromyography, given its reduced cost and less time spent on evaluation. It is also expected to demonstrate that repetitive task training is efficient and safe resistance exercises.

Being tested
Repetitive task training
Keywords
exercise, muscle function, functional capacity, quality of life
Medical subject headings
Myositis, Dermatomyositis, Polymyositis, Motor Activity

What participants receive

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

  • Repetitive task trainingOther

    The repetitive task training group will carry out exercises involving upper and lower limbs.

Study groups in NCT05027152
Study groupRoleWhat they receive
repetitive task trainingExperimentalThe repetitive task training group will carry out exercises involving upper and lower limbs.
Receives: Other: Repetitive task training

What is being measured

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

  1. muscle performance endurance

    "Myositis Functional Index-3 (FI-3)"; number of repetition of each muscle group task from 0-60

    Measured: 2 years

  2. computerized muscle endurance test

    "isokinetic dynamometry"; number of repetitions of shoulder and hip flexion until exhaustion

    Measured: 2 years

Secondary outcomes (13)
  1. manual muscle strength test

    "Manual Muscle Test 8"; Score from 0-10, higher scores mean a better outcome

    Measured: 2 years

  2. computerized muscle strength test

    "isokinetic dynamometry"; mean of 3 concentric peak torque of shoulder and hip flexion

    Measured: 2 years

  3. cardiopulmonary capacity

    "6-minute walk test"; greater time mean a better outcome

    Measured: 2 years

  4. functional capacity

    "Health Assessment Questionnaire"; Score from 0-3, score from 0-100, higher scores mean a worse outcome

    Measured: 2 years

  5. quality of life level

    "Medical Outcomes Short-Form Health Survey (SF-36)";Score from 0-100, higher scores mean a better outcome

    Measured: 2 years

  6. disease activity by physician

    "Physician Global Assessment (PGA)"; Score from 0-10, higher scores mean a worse outcome

    Measured: 2 years

  7. disease activity by patient

    "Subjective Global Assessment (SGA)"; Score from 0-10, higher scores mean a worse outcome

    Measured: 2 years

  8. disease activity questionnaire

    "Myositis Disease Activity Assessment Tool (MDAAT)"; This is a combined tool that captures the physician's assessment of disease activity of various organ systems using the 0-4 scale and a visual analog scale (VAS) from 0-10cm

    Measured: 2 years

  9. laboratory parameters of disease activity I

    "creatine phosphokinase"; units/L

    Measured: 2 years

  10. laboratory parameters of disease activity II

    aldolase; units/L

    Measured: 2 years

  11. disease damage

    "Myositis Damage Index (MDI)"; 10 cm visual analogue scale scores for each of the eleven individual organ systems

    Measured: 2 years

  12. muscle activation

    electromyography during shoulder and hip flexion; motor unit action potentials (MUAPs)

    Measured: 2 years

  13. muscle damage

    magnetic resonance imaging of thigh muscles; muscle damage and fatty infiltration

    Measured: 2 years

Timeline

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

  1. First posted30 Aug 2021
  2. Study start1 Sep 2021
  3. Primary completion1 Sep 2022
  4. Study completion1 Sep 2023

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
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
2 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05027152
Sponsor's protocol ID
FUEspiritoSanto02
Status last verified
Mar 2026
First submitted
29 Jul 2021
Last updated
23 Mar 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A study testing Repetitive task training in people with Idiopathic Inflammatory Myopathy and Dermatomyositis, run by Federal University of Espirito Santo 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 6 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 23 Mar 2026. 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?

muscle performance endurance (time frame: 2 years). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?
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 23 Mar 2026.

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