Exercise in Juvenile Takayasu Disease

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Takayasu’s arteritis
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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