Fibromyalgia
Conditions
Interventions
This is a blind, parallel, randomized controlled clinical trial with four arms. Based on the pre-established sample size calculation, 40 participants will be needed, and they will be divided into four
AEPTG: aerobic exercise and placebo transcutaneous ILIB (n = 10)
ATG: active transcutaneous ILIB (n = 10)
and PTG: placebo transcutaneous ILIB (n = 10). Both AEATG and AEPTG will follow the same exercise protocol, which will be supervised and consist of aerobic exercises based on the American College of R
Aerobic training phase on a stationary bicycle with load progression (20 minutes) pedaling with load increments in order to maintain maximum heart rate between 75-80%
participants will be encouraged to increase the load if the heart rate is below the maximum heart rate predicted by the equation or decrease it if it is above the expected rate
Cooling-down phase (5 minutes): stretching of the main muscle groups: biceps, trapezius, latissimus dorsi, pectoral, paraspinal, hamstrings, and quadriceps. The maximum heart rate will be calculated u
G11.427.410.698.277
E02.774
Sponsors
Universidade Federal de São Paulo - Campus Baixada Santista
Universidade Federal de São Paulo - Campus Baixada Santista
Eligibility
Sex/Gender
Female
Age
18 Years to 60 Years
Inclusion criteria
Inclusion criteria: Women; aged between 18 years and 60 years; who have been diagnosed with fibromyalgia (the diagnosis will be made by a patient's own referring physician and confirmed by a PhD physiotherapist with eight years of experience in the field of rheumatology, taking into consideration the diagnostic criteria for fibromyalgia set forth by the American College of Rheumatology); with cognitive capacity to understand the study according to the Mini Mental State Examination cutoff score; classified as little active and irregularly active according to criteria established by the International Physical Activity Questionnaire - short version; and interest in participating in the entire experimental protocol
Exclusion criteria
Exclusion criteria: Participants with uncontrolled systemic diseases such as diabetes mellitus and systemic arterial hypertension; neurological and musculoskeletal conditions that could directly interfere with assessments, such as paralysis, significant sensory alterations, advanced joint diseases (such as joint replacements or osteoarthritis); absolute contraindication to phototherapy, such as the presence of neoplasia; individuals with malnutrition (Body Mass Index -BMI) less than 18.5 kg/m2) or morbid obesity (Body Mass Index -BMI greater than or equal to 40 kg/m2)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| We expect to find an improvement in pain levels as measured by the Visual Analog Scale and pressure pain threshold as measured by the digital algometer, a reduction in the impact of fibromyalgia on quality of life as measured by the Revised Fibromyalgia Impact Questionnaire (FIQR), and an improvement in quality of life as measured by the Medical Outcomes Study 36-item Short Form Health Survey (SF-36). | — |
Secondary
| Measure | Time frame |
|---|---|
| We expect to find an improvement in perceived fatigue levels as measured by the Fatigue Severity Scale (FSS) and performance-related fatigue as measured by the Biodex Multi-Joint System 4 isokinetic dynamometer, as well as functional capacity as measured by the Timed Up-and-Go (TUG) test and the 6-Minute Walk Test (6MWT). | — |
Countries
Brazil
Contacts
Public ContactCristiano Carvalho
Universidade Federal de São Paulo - Campus Baixada Santista
Outcome results
None listed