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Effects of aerobic exercise associated with systemic laser in women with fibromyalgia

Effects of an aerobic exercise protocol associated with systemic photobiomodulation on cardiorespiratory fitness, fatigue and functional capacity in women with fibromyalgia

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
REBEC
Registry ID
RBR-64mpg85
Enrollment
Unknown
Registered
2024-10-03
Start date
2024-09-01
Completion date
Unknown
Last updated
2025-10-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Fibromyalgia

Interventions

This is a randomized blinded clinical trial based on the previous sample size calculation 75 participants will be required and will be divided into three groups GEAIA Aerobic exercise and active trans
E02.774

Sponsors

Departamento de Biociências -Baixada Santista
Lead Sponsor
Universidade Federal de São Paulo - Campus Baixada Santista
Collaborator

Eligibility

Sex/Gender
Female
Age
18 Years to 60 Years

Inclusion criteria

Inclusion criteria: This study will include individuals of female sex; aged between 18 and 60 years; with a diagnosis of FM that will be scheduled by a specialized physician selected by the patient and later confirmed by a physical therapist who holds a doctorate and has eight years of experience in the area of Rheumatology taking into account the FM diagnostic criteria of the American College of Rheumatology Widespread Pain Index WPI greater or equal to 7 and Symptom Severity Scale ESS greater or equal to 5 or WPI of 4 to 6 and ESS score greater or equal to 9 widespread pain defined as pain in at least 4 of the 5 regions jaw symptoms and abdominal pain are not included in the definition of widespread pain and symptoms present for at least 3 months with cognitive capacity to understand the study according to the cut-off score of the Mini-Mental State Examination classified as slightly active and irregularly active according to criteria established by the International Physical Activity Questionnaire administered in its short version have a medical certificate allowing physical activity and interest in participating in the entire experimental protocol

Exclusion criteria

Exclusion criteria: Presence of uncontrolled systemic diseases, such as diabetes mellitus and systemic arterial hypertension; Neurological and musculoskeletal conditions that may directly interfere with the evaluations, such as paralysis, significant changes in sensitivity, advanced joint diseases (such as arthroplasties or osteoarthritis); Individuals who are malnourished (BMI < 18.5 kg/m2) or morbidly obese (BMI = 40 kg/m2); Absolute contraindication for photobiomodulation, such as the presence of neoplasia; Failure to present a medical certificate to perform physical exercise will prevent participation in the research

Design outcomes

Primary

MeasureTime frame
It is expected to find an improvement in cardiorespiratory capacity through the variables: maximum oxygen consumption (VO2 max); and anaerobic threshold that will be analyzed through the cardiopulmonary ergometric test.

Secondary

MeasureTime frame
It is expected to find an improvement in the level of perceived fatigue assessed by the Fatigue Severity Scale (FSS) and performance fatigue measured by the Biodex Multi-Joint System 4 isokinetic dynamometer, improvement in the level of pain measured by the Visual Analog Scale, less impact of FM on quality of life assessed by the Revised Fibromyalgia Impact Questionnaire (FIQR) and improvement in functional capacity assessed by the 6-Minute Walk Test (6MWT)

Countries

Brazil

Contacts

Public ContactThatiane Santos

Universidade Federal de São Paulo - Campus Baixada Santista

thatiane.i.ribeiro@hotmail.com+55(13)981113855

Outcome results

None listed

Source: REBEC (via WHO ICTRP)