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

NCT05027152 | Completed

• 1 other identifier: FUEspiritoSanto02
• Study Type: interventional
• Target: 2
• Locations: 1 country
• Sites: 1

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 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.

Conditions

Dermatomyositis; Polymyositis; Idiopathic Inflammatory Myopathy

Keywords

exercise; muscle function; functional capacity; quality of life

Outcome Measures

Primary Outcomes (2)

• muscle performance endurance

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

  2 years

• computerized muscle endurance test

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

  2 years

Secondary Outcomes (13)

• manual muscle strength test

  2 years

• computerized muscle strength test

  2 years

• cardiopulmonary capacity

  2 years

• functional capacity

  2 years

• quality of life level

  2 years

Study Arms (1)

repetitive task training

EXPERIMENTAL

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

Other: Repetitive task training

Interventions

Repetitive task training OTHER

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

repetitive task training

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• Federal University of Espirito Santo: lead

Study Sites (1)

Samira Tatiyama Miyamoto, PhD

Vitória, Espírito Santo, 29050-780, Brazil

Location

MeSH Terms

Conditions

Myositis; Dermatomyositis; Polymyositis; Motor Activity

Condition Hierarchy (Ancestors)

Muscular Diseases; Musculoskeletal Diseases; Neuromuscular Diseases; Nervous System Diseases; Connective Tissue Diseases; Skin and Connective Tissue Diseases; Skin Diseases; Behavior

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: July 29, 2021
• First Posted: August 30, 2021
• Study Start: September 1, 2021
• Primary Completion: September 1, 2022
• Study Completion: September 1, 2023
• Last Updated: March 23, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

BR (1)