Scleroderma Systemic
Conditions
Interventions
This is a randomized controlled clinical trial. The sample will consist of both male and female individuals, aged 18 to 65, diagnosed with systemic sclerosis and with a score of 1 or higher on the Scl
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Sponsors
Departamento de Fisioterapia da Universidade Federal de Pernambuco
Hospital das Clínicas da Universidade Federal de Pernambuco
Universidade Federal de Pernambuco
Eligibility
Age
18 Years to 65 Years
Inclusion criteria
Inclusion criteria: Adults (18-65 years); both sexes; with a Scleroderma Health Assessment Questionnaire score of 1 or higher; and a diagnosis of Systemic Sclerosis according to the 2013 American College of Rheumatology / European League Against Rheumatism (ACR/EULAR) classification criteria
Exclusion criteria
Exclusion criteria: Pregnancy; diagnosis of malignancy; changes in drug treatment in the last three months; physical therapy care in the last three months; overlap with other autoimmune rheumatic diseases; dysfunctions that limit physical activity, such as severe neurological impairment, immobility or cooperation deficits; individuals who have a regular exercise habit (at least three days per week); New York Heart Association level III or IV classification; joint surgery in the six months prior to inclusion
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| It is expected to find a decrease in the degree of disability of individuals, assessed through the application of the Scleroderma Health Assessment Questionnaire, which generates a score ranging from 0 to 3, where a lower score indicates a lower degree of disability | — |
Secondary
| Measure | Time frame |
|---|---|
| It is expected to find a decrease in the severity of fatigue in individuals, assessed by the Fatigue Severity Scale questionnaire, whose score varies between 1 and 7, with higher scores reflecting greater fatigue;We hypothesize that we will find a decrease in hand disability, as measured by the Cochin Hand Functional Scale, with scores ranging from 0 to 90, where higher scores indicate greater hand disability;We expect to find a decrease in anxiety and depression symptoms, as assessed by the Hospital Anxiety and Depression Scale (HADS). The HADS generates a score ranging from 0 to 21, with higher scores indicating more severe anxiety and depression symptoms;It is expected to find an increase in individual resilience, as assessed by the Connor-Davidson Resilience Scale. This scale generates scores ranging from 0 to 40, with higher scores indicating greater resilience;We expect to find an increase in lower extremity strength, as assessed by the 30-second chair stand test. The number of repetitions will be used as a measure of muscular strength, with a higher number of repetitions indicating greater strength.;We expect to find an increase in grip strength, as measured by hand dynamometry. Higher values will indicate greater hand grip strength.;We expect an increase in the distance covered in the 6-minute walk test.;A decrease in serum levels of Interleukin (IL)-6 and IL-8 is expected. | — |
Countries
Brazil
Contacts
Public ContactGabriela Santos
Departamento de Fisioterapia da Universidade Federal de Pernambuco
Outcome results
None listed