Clinical trial NCT03494062: Exercise in Juvenile Takayasu Disease
Official title: Exercise in Juvenile Takayasu Disease: a Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Takayasu's Arteritis
Lead sponsor: University of Sao Paulo
Sponsor class: OTHER
Collaborators: name: Federal University of São Paulo
First posted: 2018-04-11
Enrollment: 21
Sex: ALL
Minimum age (years): 7
Maximum age (years): 25
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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)

Primary outcomes:
measure: Arterial inflammation
timeFrame: 12 weeks
measure: Blood inflammatory markers
timeFrame: 12 weeks
measure: Blood inflammatory marker
timeFrame: 12 weeks
measure: velocity sedimentation rate
timeFrame: 12 weeks
Secondary outcomes:
measure: Maximal aerobic capacity
timeFrame: 12 weeks
measure: Body composition
timeFrame: 12 weeks
measure: Timed stands test
timeFrame: 12 weeks
measure: timed-up-and-go test
timeFrame: 12 weeks
measure: Isometric strength
timeFrame: 12 weeks
measure: Maximal strength test
timeFrame: 12 weeks
measure: The Paediatric Vasculitis Activity Score (PVAS)
timeFrame: 12 weeks
measure: National Institute of Health (NIH)
timeFrame: 12 weeks
measure: Indian Takayasu's Arteritis Activity Score 2010 (ITAS2010
timeFrame: 12 weeks
measure: Childhood Health Assessment Questionaire (CHAQ)
timeFrame: 12 weeks
measure: Physical activity levels
timeFrame: 12 weeks
measure: Fatigue severity scale FSS
timeFrame: 12 weeks
measure: Quality of life
timeFrame: 12 weeks
measure: Hypotension after acute exercise session
timeFrame: 12 weeks
Other outcomes:
Locations:
city: São Paulo
country: Brazil
facility: University of Sao Paulo
state: Castanho
Study officials:
affiliation: University of Sao Paulo
name: Bruno BG Gualano, Professor
role: PRINCIPAL_INVESTIGATOR
References:
citation: Astley C, Clemente G, Terreri MT, Carneiro CG, Lima MS, Buchpiguel CA, Leao Filho H, de Sa Pinto AL, Silva CA, Campos LMA, Aikawa NE, Gil S, Pereira RMR, Roschel H, Gualano B. Home-Based Exercise Training in Childhood-Onset Takayasu Arteritis: A Multicenter, Randomized, Controlled Trial. Front Immunol. 2021 Jul 28;12:705250. doi: 10.3389/fimmu.2021.705250. eCollection 2021.