Clinical Trials Directory

Trials / Unknown

UnknownNCT03494062

Exercise in Juvenile Takayasu Disease

Exercise in Juvenile Takayasu Disease: a Randomized Controlled Trial

Status
Unknown
Phase
N/A
Study type
Interventional
Enrollment
21 (estimated)
Sponsor
University of Sao Paulo · Academic / Other
Sex
All
Age
7 Years – 25 Years
Healthy volunteers
Not accepted

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.

Conditions

Interventions

TypeNameDescription
BEHAVIORALExerciseHome-based exercise training

Timeline

Start date
2018-03-05
Primary completion
2019-12-30
Completion
2019-12-30
First posted
2018-04-11
Last updated
2018-04-11

Locations

1 site across 1 country: Brazil

Source: ClinicalTrials.gov record NCT03494062. Inclusion in this directory is not an endorsement.