Exercise in Juvenile Takayasu Disease

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

21 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-03-05

Study Completion Date

2019-12-30

Brief Summary

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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.

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Detailed Description

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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

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Takayasu's Arteritis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Caregivers

Study Groups

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Exercise

Home-based exercise intervention

Group Type EXPERIMENTAL

Exercise

Intervention Type BEHAVIORAL

Home-based exercise training

Control

Usual care

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Exercise

Home-based exercise training

Intervention Type BEHAVIORAL

Eligibility Criteria

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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)

Minimum Eligible Age

7 Years

Maximum Eligible Age

25 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No