- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05027152
Muscle Function and Effects of Repetitive Task Training in Patients With Inflammatory Myopaties
August 24, 2021 updated by: Samira Tatiyama Miyamoto, PhD, Federal University of Espirito Santo
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 compare the effects of a repetitive task training program with a resistance exercise 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 as efficient and safe as resistance exercises.
Study Overview
Status
Not yet recruiting
Intervention / Treatment
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, the 30 patients evaluated in the observational study will be randomized into two intervention groups.
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 resistance training group will perform traditional resistance exercises with an intensity of 30%-60% of a voluntary repetition maximum and 1 to 2 sets of 10 repetitions each exercise.
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 comparison before and after the training programs will be performed using the t-test or Mann-Whitney; the comparison between groups will be performed using ANOVA; 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 as efficient and safe as resistance exercises.
Study Type
Interventional
Enrollment (Anticipated)
30
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Samira T Miyamoto, PhD
- Phone Number: +55 27 997606447
- Email: sa.miyamoto@hotmail.com
Study Locations
-
-
ES
-
Vitória, ES, Brazil, 29050-780
- Samira Tatiyama Miyamoto, PhD
-
Contact:
- Samira T Miyamoto, PhD
- Phone Number: +55 27 997606447
- Email: sa.miyamoto@hotmail.com
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: traditional resistance exercises
The resistance training group will perform traditional resistance exercises with an intensity of 30%-60% of a voluntary repetition maximum and 1 to 2 sets of 10 repetitions each exercise.
|
The resistance training group will perform traditional resistance exercises with an intensity of 30%-60% of a voluntary repetition maximum and 1 to 2 sets of 10 repetitions each exercise.
The repetitive task training group will carry out exercises involving upper and lower limbs.
|
Experimental: repetitive task training
The repetitive task training group will carry out exercises involving upper and lower limbs.
|
The repetitive task training group will carry out exercises involving upper and lower limbs.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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 years
|
computerized muscle endurance test
Time Frame: 2 years
|
"isokinetic dynamometry"; number of repetitions of shoulder and hip flexion until exhaustion
|
2 years
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
manual muscle strength test
Time Frame: 2 years
|
"Manual Muscle Test 8"; Score from 0-10, higher scores mean a better outcome
|
2 years
|
computerized muscle strength test
Time Frame: 2 years
|
"isokinetic dynamometry"; mean of 3 concentric peak torque of shoulder and hip flexion
|
2 years
|
cardiopulmonary capacity
Time Frame: 2 years
|
"6-minute walk test"; greater time mean a better outcome
|
2 years
|
functional capacity
Time Frame: 2 years
|
"Health Assessment Questionnaire"; Score from 0-3, score from 0-100, higher scores mean a worse outcome
|
2 years
|
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
|
2 years
|
disease activity by physician
Time Frame: 2 years
|
"Physician Global Assessment (PGA)"; Score from 0-10, higher scores mean a worse outcome
|
2 years
|
disease activity by patient
Time Frame: 2 years
|
"Subjective Global Assessment (SGA)"; Score from 0-10, higher scores mean a worse outcome
|
2 years
|
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
|
2 years
|
laboratory parameters of disease activity I
Time Frame: 2 years
|
"creatine phosphokinase"; units/L
|
2 years
|
laboratory parameters of disease activity II
Time Frame: 2 years
|
aldolase; units/L
|
2 years
|
disease damage
Time Frame: 2 years
|
"Myositis Damage Index (MDI)"; 10 cm visual analogue scale scores for each of the eleven individual organ systems
|
2 years
|
muscle activation
Time Frame: 2 years
|
electromyography during shoulder and hip flexion; motor unit action potentials (MUAPs)
|
2 years
|
muscle damage
Time Frame: 2 years
|
magnetic resonance imaging of thigh muscles; muscle damage and fatty infiltration
|
2 years
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Anticipated)
September 1, 2021
Primary Completion (Anticipated)
September 1, 2022
Study Completion (Anticipated)
September 1, 2023
Study Registration Dates
First Submitted
July 29, 2021
First Submitted That Met QC Criteria
August 24, 2021
First Posted (Actual)
August 30, 2021
Study Record Updates
Last Update Posted (Actual)
August 30, 2021
Last Update Submitted That Met QC Criteria
August 24, 2021
Last Verified
August 1, 2021
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- FUEspiritoSanto
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
No
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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