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

Primary Purpose

Idiopathic Inflammatory Myopathy, Dermatomyositis, Polymyositis

Status
Unknown status
Phase
Not Applicable
Locations
Brazil
Study Type
Interventional
Intervention
Resistance training
Repetitive task training
Sponsored by
Federal University of Espirito Santo
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Idiopathic Inflammatory Myopathy focused on measuring exercise, muscle function, functional capacity, quality of life

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Samira Tatiyama Miyamoto, PhD

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

traditional resistance exercises

repetitive task training

Arm Description

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.

Outcomes

Primary Outcome Measures

muscle performance endurance
"Myositis Functional Index-3 (FI-3)"; number of repetition of each muscle group task from 0-60
computerized muscle endurance test
"isokinetic dynamometry"; number of repetitions of shoulder and hip flexion until exhaustion

Secondary Outcome Measures

manual muscle strength test
"Manual Muscle Test 8"; Score from 0-10, higher scores mean a better outcome
computerized muscle strength test
"isokinetic dynamometry"; mean of 3 concentric peak torque of shoulder and hip flexion
cardiopulmonary capacity
"6-minute walk test"; greater time mean a better outcome
functional capacity
"Health Assessment Questionnaire"; Score from 0-3, score from 0-100, higher scores mean a worse outcome
quality of life level
"Medical Outcomes Short-Form Health Survey (SF-36)";Score from 0-100, higher scores mean a better outcome
disease activity by physician
"Physician Global Assessment (PGA)"; Score from 0-10, higher scores mean a worse outcome
disease activity by patient
"Subjective Global Assessment (SGA)"; Score from 0-10, higher scores mean a worse outcome
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
laboratory parameters of disease activity I
"creatine phosphokinase"; units/L
laboratory parameters of disease activity II
aldolase; units/L
disease damage
"Myositis Damage Index (MDI)"; 10 cm visual analogue scale scores for each of the eleven individual organ systems
muscle activation
electromyography during shoulder and hip flexion; motor unit action potentials (MUAPs)
muscle damage
magnetic resonance imaging of thigh muscles; muscle damage and fatty infiltration

Full Information

First Posted
July 29, 2021
Last Updated
August 24, 2021
Sponsor
Federal University of Espirito Santo
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1. Study Identification

Unique Protocol Identification Number
NCT05027152
Brief Title
Muscle Function and Effects of Repetitive Task Training in Patients With Inflammatory Myopaties
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
Study Type
Interventional

2. Study Status

Record Verification Date
August 2021
Overall Recruitment Status
Unknown status
Study Start Date
September 1, 2021 (Anticipated)
Primary Completion Date
September 1, 2022 (Anticipated)
Study Completion Date
September 1, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Federal University of Espirito Santo

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief 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 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Idiopathic Inflammatory Myopathy, Dermatomyositis, Polymyositis
Keywords
exercise, muscle function, functional capacity, quality of life

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Group 1: Traditional resistance exercises. Group 2:The repetitive task training group
Masking
InvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
30 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
traditional resistance exercises
Arm Type
Experimental
Arm Description
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.
Arm Title
repetitive task training
Arm Type
Experimental
Arm Description
The repetitive task training group will carry out exercises involving upper and lower limbs.
Intervention Type
Other
Intervention Name(s)
Resistance training
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
Repetitive task training
Intervention Description
The repetitive task training group will carry out exercises involving upper and lower limbs.
Primary Outcome Measure Information:
Title
muscle performance endurance
Description
"Myositis Functional Index-3 (FI-3)"; number of repetition of each muscle group task from 0-60
Time Frame
2 years
Title
computerized muscle endurance test
Description
"isokinetic dynamometry"; number of repetitions of shoulder and hip flexion until exhaustion
Time Frame
2 years
Secondary Outcome Measure Information:
Title
manual muscle strength test
Description
"Manual Muscle Test 8"; Score from 0-10, higher scores mean a better outcome
Time Frame
2 years
Title
computerized muscle strength test
Description
"isokinetic dynamometry"; mean of 3 concentric peak torque of shoulder and hip flexion
Time Frame
2 years
Title
cardiopulmonary capacity
Description
"6-minute walk test"; greater time mean a better outcome
Time Frame
2 years
Title
functional capacity
Description
"Health Assessment Questionnaire"; Score from 0-3, score from 0-100, higher scores mean a worse outcome
Time Frame
2 years
Title
quality of life level
Description
"Medical Outcomes Short-Form Health Survey (SF-36)";Score from 0-100, higher scores mean a better outcome
Time Frame
2 years
Title
disease activity by physician
Description
"Physician Global Assessment (PGA)"; Score from 0-10, higher scores mean a worse outcome
Time Frame
2 years
Title
disease activity by patient
Description
"Subjective Global Assessment (SGA)"; Score from 0-10, higher scores mean a worse outcome
Time Frame
2 years
Title
disease activity questionnaire
Description
"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
Title
laboratory parameters of disease activity I
Description
"creatine phosphokinase"; units/L
Time Frame
2 years
Title
laboratory parameters of disease activity II
Description
aldolase; units/L
Time Frame
2 years
Title
disease damage
Description
"Myositis Damage Index (MDI)"; 10 cm visual analogue scale scores for each of the eleven individual organ systems
Time Frame
2 years
Title
muscle activation
Description
electromyography during shoulder and hip flexion; motor unit action potentials (MUAPs)
Time Frame
2 years
Title
muscle damage
Description
magnetic resonance imaging of thigh muscles; muscle damage and fatty infiltration
Time Frame
2 years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Samira T Miyamoto, PhD
Phone
+55 27 997606447
Email
sa.miyamoto@hotmail.com
Facility Information:
Facility Name
Samira Tatiyama Miyamoto, PhD
City
Vitória
State/Province
ES
ZIP/Postal Code
29050-780
Country
Brazil
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Samira T Miyamoto, PhD
Phone
+55 27 997606447
Email
sa.miyamoto@hotmail.com

12. IPD Sharing Statement

Plan to Share IPD
No

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

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