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.
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
- Conditions the study is for
- Idiopathic Inflammatory Myopathy, Dermatomyositis, Polymyositis
- 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.
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 group | Role | What they receive |
|---|---|---|
| repetitive task training | Experimental | The 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.
muscle performance endurance
"Myositis Functional Index-3 (FI-3)"; number of repetition of each muscle group task from 0-60
Measured: 2 years
computerized muscle endurance test
"isokinetic dynamometry"; number of repetitions of shoulder and hip flexion until exhaustion
Measured: 2 years
Secondary outcomes (13)
manual muscle strength test
"Manual Muscle Test 8"; Score from 0-10, higher scores mean a better outcome
Measured: 2 years
computerized muscle strength test
"isokinetic dynamometry"; mean of 3 concentric peak torque of shoulder and hip flexion
Measured: 2 years
cardiopulmonary capacity
"6-minute walk test"; greater time mean a better outcome
Measured: 2 years
functional capacity
"Health Assessment Questionnaire"; Score from 0-3, score from 0-100, higher scores mean a worse outcome
Measured: 2 years
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
disease activity by physician
"Physician Global Assessment (PGA)"; Score from 0-10, higher scores mean a worse outcome
Measured: 2 years
disease activity by patient
"Subjective Global Assessment (SGA)"; Score from 0-10, higher scores mean a worse outcome
Measured: 2 years
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
laboratory parameters of disease activity I
"creatine phosphokinase"; units/L
Measured: 2 years
laboratory parameters of disease activity II
aldolase; units/L
Measured: 2 years
disease damage
"Myositis Damage Index (MDI)"; 10 cm visual analogue scale scores for each of the eleven individual organ systems
Measured: 2 years
muscle activation
electromyography during shoulder and hip flexion; motor unit action potentials (MUAPs)
Measured: 2 years
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.
- First posted30 Aug 2021
- Study start1 Sep 2021
- Primary completion1 Sep 2022
- Study completion1 Sep 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Idiopathic Inflammatory MyopathyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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)
Sponsor and investigators
- Lead sponsor
- Federal University of Espirito Santo
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Samira Tatiyama Miyamoto, PhD, Federal University of Espirito Santo
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
Study at a glance
From the registry record, last updated by the sponsor on 23 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT05027152
- Acronym / sponsor ID
- FUEspiritoSanto02
- Keywords
- exercise, muscle function, functional capacity, quality of life
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 2 participants (actual)
- Lead sponsor
- Federal University of Espirito SantoUniversity, hospital or other
- Study start
- 1 Sep 2021 (actual)
- Primary completion
- 1 Sep 2022 (actual)
- Study completion
- 1 Sep 2023 (actual)
- First posted
- 30 Aug 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| repetitive task training | Experimental | Other: Repetitive task trainingThe repetitive task training group will carry out exercises involving upper and lower limbs. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (6 listed)
- serious cardiac or pulmonary conditions
- severe osteoporosis
- unable to exercise
- neoplasm
- cognitive disorders
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Repetitive task trainingThe repetitive task training group will carry out exercises involving upper and lower limbs. | Other | repetitive task training |
Primary outcome
muscle performance endurance
Time frame: 2 years
"Myositis Functional Index-3 (FI-3)"; number of repetition of each muscle group task from 0-60
computerized muscle endurance test
Time frame: 2 years
"isokinetic dynamometry"; number of repetitions of shoulder and hip flexion until exhaustion
13 secondary outcomes
manual muscle strength test
Time frame: 2 years
computerized muscle strength test
Time frame: 2 years
cardiopulmonary capacity
Time frame: 2 years
functional capacity
Time frame: 2 years
quality of life level
Time frame: 2 years
disease activity by physician
Time frame: 2 years
disease activity by patient
Time frame: 2 years
disease activity questionnaire
Time frame: 2 years
laboratory parameters of disease activity I
Time frame: 2 years
laboratory parameters of disease activity II
Time frame: 2 years
disease damage
Time frame: 2 years
muscle activation
Time frame: 2 years
muscle damage
Time frame: 2 years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Mar 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
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.