Polymyositis Dermatomyositis
Conditions
Interventions
This is a single-arm, non-randomized, uncontrolled, unblinded clinical study. Experimental group (single group): Ten individuals with inflammatory myopathy will undergo 24 sessions of resistance exerc
Sponsors
Universidade Estadual de Campinas
Universidade Estadual de Campinas
Eligibility
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: Volunteers with a diagnosis of idiopathic inflammatory myopathy; aged eighteen years or older; of either sex; complete clinical response to their current treatment
Exclusion criteria
Exclusion criteria: New York Heart Association functional classes three or four heart failure; any sustained ventricular arrhythmia or atrial arrhythmia with uncontrolled heart rate; interstitial lung disease with symptoms corresponding to a modified Medical Research Council dyspnea score greater than two; active systemic infections; muscle weakness of neurological origin; joint limitations that preclude exercise performance; pregnancy; severe cognitive impairment that compromises the safe use of the neurostimulator; use of anabolic steroids within the previous three months; use of creatine within the previous four weeks; and current participation in an exercise program involving more than a hundred and fifty minutes per week of physical activity of at least moderate intensity
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Good safety of the protocol is expected, as assessed by the number of adverse events classified according to the Common Terminology Criteria for Adverse Events (CTCAE), defined by the occurrence of fewer than 50% of participants experiencing mild or moderate adverse events and the absence of any severe adverse events | — |
Secondary
| Measure | Time frame |
|---|---|
| Good adherence to the protocol is expected, as assessed by the proportion of attended sessions relative to the total number of planned sessions, defined as an attendance rate of at least 75%;An increase in peak isometric strength, measured by dynamometry, is expected, as evidenced by a statistically significant improvement between the pre- and post-intervention assessments;An increase in walking distance, measured by the 6-minute walk test, is expected, as evidenced by a statistically significant improvement between the pre- and post-intervention assessments;An increase in the number of repetitions during a functional exercise, measured by the 30-second sit-to-stand test, is expected, as evidenced by a statistically significant improvement between the pre- and post-intervention assessments;An increase in quadriceps muscle volume, measured by the cross-sectional area obtained by ultrasound, is expected, as evidenced by a statistically significant improvement between the pre- and post-intervention assessments | — |
Countries
BR
Contacts
Public ContactJean De Souza
Universidade Estadual de Campinas
Outcome results
None listed