Brief Title
Exercise in Juvenile Takayasu Disease
Official Title
Exercise in Juvenile Takayasu Disease: a Randomized Controlled Trial
Brief Summary
Juvenile Takayasu disease is characterized by chronic inflammation that leads to vascular disease. Exercise may render anti-inflammatory effects and protect against cardiovascular events. This trial aims to investigate the therapeutic role of exercise in juvenile Takayasu disease.
Detailed Description
Takayasu's Arteritis (TA) is a chronic inflammatory disease that affects large and medium-sized arteries. The number of cases describe in children and adolescents has growing, and the hypertension is one of the symptoms most common, followed by other manifestations that affects cardiovascular systems. All clinical manifestations may aggravate by physical inactivity and can creating a vicious cycle of inflammation, whereas the risks of morbidity and mortality increase significantly in the pediatric population, impairing function and physical capacity, quality of life and evolution to adult life. Thereby, physical exercise it is show to be an efficient strategy to reduce all these risk factors, however, no one study, until now, was conducted to available the effects of exercise in children with TA. Objective: Investigated the effects of 12-week home-based exercise program, where the patients receive a guideline from a physical education professional, teaching how to do the exercise at home. The beneficial effects of the programs expect is to be associated with improved cardiovascular risk factors, function and physical capacity, and body composition. Methods: This is a prospective, longitudinal and randomized clinical trial. All patients will be recruited at the Clinical Hospital of the University of Sao Paulo Medical School (HC-FMUSP), in the Laboratory of Evaluation and Conditioning in Rheumatology, Pediatric Rheumatology outpatient clinics of the Department of Pediatrics, Federal University of São Paulo and The Children's Institute of the University of São Paulo and the Vasculitis Unit of the HC-FMUSP Rheumatology Service. In order to evaluate the therapeutic effects of exercise program act on TA, the following pre and post intervention evaluations will be performed: physical activity level; Global clinical evaluation; Anthropometry and body composition; Hematological and inflammatory blood parameters; Cardiovascular risk factors; Aerobic capacity; Functional capacity and fatigue; quality of life; and 18 FDG PET with magnetic resonance angiography.
Study Type
Interventional
Primary Outcome
Arterial inflammation
Secondary Outcome
Maximal aerobic capacity
Condition
Takayasu's Arteritis
Intervention
Exercise
Study Arms / Comparison Groups
Exercise
Description: Home-based exercise intervention
Publications
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
Recruitment Information
Recruitment Status
Behavioral
Estimated Enrollment
21
Start Date
March 5, 2018
Completion Date
December 30, 2019
Primary Completion Date
December 30, 2019
Eligibility Criteria
Inclusion Criteria: - diagnosis of juvenile Takayasu disease Exclusion Criteria: - cardiac and renal insufficiency - physical limitation hampering exercise training - non-controlled metabolic disorders - associated chronic diseases (last 6 months)
Gender
All
Ages
7 Years - 25 Years
Accepts Healthy Volunteers
No
Contacts
Bruno BG Gualano, Professor, 5511964721104, [email protected]
Location Countries
Brazil
Location Countries
Brazil
Administrative Informations
NCT ID
NCT03494062
Organization ID
Takayasu&Exercise
Responsible Party
Principal Investigator
Study Sponsor
University of Sao Paulo
Collaborators
Federal University of São Paulo
Study Sponsor
Bruno BG Gualano, Professor, Principal Investigator, University of Sao Paulo
Verification Date
April 2018