ClinicalTrials.gg
CompletedNCT05027152Updated Mar 23, 2026

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

An interventional study of Repetitive task training in Idiopathic Inflammatory Myopathy, Dermatomyositis and Polymyositis, sponsored by Federal University of Espirito Santo. Completed at 1 site in Brazil. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-03-23.

Primary conditionDermatomyositisRegistry: MyositisReclassifiedWhy we changed it
Registry
Myositis — the first condition term the registry derived for this study.
ClinicalTrials.gg
Dermatomyositis
Why
  1. The study's listed conditions name Dermatomyositis, a narrower term within Myositis.
Confidence
High: the new condition is named in the study's own listed conditions. Of 351 hand-checked studies reclassified this way, 68% were exactly right and 84% in the right disease family; the registry's first term was right for 5% (measured 2026-10-21). How we classify →
Wrong?
Tell us the study's main condition →

Sponsored by Federal University of Espirito Santo · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
2
Allocation
Not applicable
Ages
18 Years and older
Sex
All
01

Study 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. 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.

02

Conditions studied

  • Idiopathic Inflammatory Myopathy
  • Dermatomyositis
  • Polymyositis

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Keywords

  • exercise
  • muscle function
  • functional capacity
  • quality of life
03

In context

Dermatomyositis Reclassified

184 studies on the registry are indexed under Dermatomyositis; 63 are open to participants now.

This study's enrollment of 2 is below the median of 35 across 130 interventional studies indexed under Dermatomyositis.

Browse Dermatomyositis studies →

Lead sponsor

Federal University of Espirito Santo is the lead sponsor of 16 studies on the registry; 2 are open to participants now.

Compared within Dermatomyositis, this study's primary condition as ClinicalTrials.gg classifies it; the registry's first condition term is Myositis. The counts are of registry records indexed under each term, refreshed daily. How we classify →

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
Yes

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • 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

Exclusion criteria

Exclusion Criteria:

  • serious cardiac or pulmonary conditions
  • severe osteoporosis
  • unable to exercise
  • neoplasm
  • cognitive disorders
  • acute or chronic infection
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
2 participants (actual)

Study arms

  • Experimental
    repetitive task training

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

    Other: Repetitive task training

Interventions

  • OtherRepetitive task training

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

06

What researchers measure

Primary outcomes

  1. muscle performance endurance

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

    Time frame: 2 years

  2. computerized muscle endurance test

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

    Time frame: 2 years

Secondary outcomes

  1. manual muscle strength test

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

    Time frame: 2 years

  2. computerized muscle strength test

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

    Time frame: 2 years

  3. cardiopulmonary capacity

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

    Time frame: 2 years

  4. functional capacity

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

    Time frame: 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

    Time frame: 2 years

  6. disease activity by physician

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

    Time frame: 2 years

  7. disease activity by patient

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

    Time frame: 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

    Time frame: 2 years

  9. laboratory parameters of disease activity I

    "creatine phosphokinase"; units/L

    Time frame: 2 years

  10. laboratory parameters of disease activity II

    aldolase; units/L

    Time frame: 2 years

  11. disease damage

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

    Time frame: 2 years

  12. muscle activation

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

    Time frame: 2 years

  13. muscle damage

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

    Time frame: 2 years

07

Study locations

1 site
  • Samira Tatiyama Miyamoto, PhD
    Vitória, Espírito Santo 29050-780, Brazil
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reached

Ran from Sep 2021 to primary completion in Sep 2022, 12 months.

How these figures are worked out, and which studies are left out of them.

Registered
Jul 29, 2021
First posted
Aug 30, 2021
StartActual
Sep 1, 2021
Primary completionActual
Sep 1, 2022
CompletionActual
Sep 1, 2023
Last update
Mar 23, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Mar 23, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT05027152
Lead sponsor
Federal University of Espirito Santo
Responsible party
Samira Tatiyama Miyamoto, PhD (Professor, Federal University of Espirito Santo) — Principal investigator
First posted
Aug 30, 2021
Start date
Sep 1, 2021
Primary completion
Sep 1, 2022
Completion
Sep 1, 2023
Last update
Mar 23, 2026

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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