Exercise in Juvenile Takayasu Disease

U

University of Sao Paulo

Status

Unknown

Conditions

Takayasu's Arteritis

Treatments

Behavioral: Exercise

Study type

Interventional

Funder types

Other

Identifiers

NCT03494062
Takayasu&Exercise

Details and patient eligibility

About

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.

Full 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.

Enrollment

21 estimated patients

Sex

All

Ages

7 to 25 years old

Volunteers

No Healthy Volunteers

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)

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Single Blind

21 participants in 2 patient groups

Exercise
Experimental group
Description:
Home-based exercise intervention
Treatment:
Behavioral: Exercise
Control
No Intervention group
Description:
Usual care

Trial contacts and locations

1

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Central trial contact

Camilla CA Astley, Masters

Data sourced from clinicaltrials.gov

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