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Completed

NCT Number: NCT05027152

Muscle Function 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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Samira Tatiyama Miyamoto, PhD

Vitória, Espírito Santo, 29050-780, Brazil

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

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

Treatment and study plan

Repetitive task training

Other

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

Primary outcomes

  1. muscle performance endurance

    Time frame: 2 years

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

  2. computerized muscle endurance test

    Time frame: 2 years

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

Secondary outcomes

  1. manual muscle strength test

    Time frame: 2 years

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

  2. computerized muscle strength test

    Time frame: 2 years

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

  3. cardiopulmonary capacity

    Time frame: 2 years

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

  4. functional capacity

    Time frame: 2 years

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

  5. quality of life level

    Time frame: 2 years

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

  6. disease activity by physician

    Time frame: 2 years

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

  7. disease activity by patient

    Time frame: 2 years

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

  8. disease activity questionnaire

    Time frame: 2 years

    "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

  9. laboratory parameters of disease activity I

    Time frame: 2 years

    "creatine phosphokinase"; units/L

  10. laboratory parameters of disease activity II

    Time frame: 2 years

    aldolase; units/L

  11. disease damage

    Time frame: 2 years

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

  12. muscle activation

    Time frame: 2 years

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

  13. muscle damage

    Time frame: 2 years

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

Sponsors and collaborators

Lead sponsor

Federal University of Espirito Santo

Other

Registry information

Official study 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

Important dates

Study start
2021
Primary completion
2022
Study completion
2023
First posted
Aug 30, 2021
Registry last updated
Mar 23, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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