An interventional study of Exercise in Takayasu's Arteritis, sponsored by University of Sao Paulo. Status unknown at 1 site in Brazil. Open to participants aged 7 Years to 25 Years. Per ClinicalTrials.gov, last updated 2018-04-11.
Sponsored by University of Sao Paulo · Not applicable, Interventional, and Treatment
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.
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.
78 studies on the registry are indexed under Takayasu Arteritis; 32 are open to participants now.
This study's planned enrollment of 21 is below the median of 50 across 37 interventional studies indexed under Takayasu Arteritis.
Browse Takayasu Arteritis studies →University of Sao Paulo is the lead sponsor of 1,035 studies on the registry; 95 are open to participants now.
Of its 8 completed or terminated interventional studies of FDA-regulated products, 0 (0%) have results posted.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Home-based exercise intervention
Behavioral: Exercise
Usual care
Home-based exercise training
Arterial inflammation
as assessed by positron emission tomography - magnetic ressonance (PET-MR)
Time frame: 12 weeks
Blood inflammatory markers
interleukin-6, interleukin 10, interleukin-12
Time frame: 12 weeks
Blood inflammatory marker
C-reactive protein
Time frame: 12 weeks
velocity sedimentation rate
velocity sedimentation rate
Time frame: 12 weeks
Maximal aerobic capacity
as assessed by maximal cardiopulmonary test
Time frame: 12 weeks
Body composition
Lean, fat and bone mass, as assessed by dual energy x-ray absorptiometry
Time frame: 12 weeks
Timed stands test
The test is performed by measuring the time to stand up and down for 30 seconds. The patient should make two attempts and the best performance will be considered for the analyzes.
Time frame: 12 weeks
timed-up-and-go test
The "Timed Up-And-Go" test, which evaluates the time it takes for the patient to get up from a chair, walk three meters, make a 180-degree turn, and return to the chair. The patient should perform two attempts and the best performance will be considered for the analyzes.
Time frame: 12 weeks
Isometric strength
handgrip test
Time frame: 12 weeks
Maximal strength test
will be performed by the maximum repetition test, where the objective is to find a maximal repetition for lower limbs by leg press exercise 45º and for upper limbs by bench press exercise
Time frame: 12 weeks
The Paediatric Vasculitis Activity Score (PVAS)
The final PVAS is a clinical index of 64 manifestations of active vasculitis, divided into five domains: general, cutaneous, cardiovascular, abdominal and renal.
Time frame: 12 weeks
National Institute of Health (NIH)
The NIH criteria is an instrument that will evalueted the disease specific symptoms and his activity. Active disease will arbitrarily defined as new onset or worsening of at least 2 of the following 4 features: (I) signs and symptoms of vascular ischemia or inflammation (e.g. claudication, decreased or absent extremity pulses or blood pressure, bruits, or carotidynia); (2) elevated erythrocyte sedimentation rate; (3) angiographic abnormalities; and (4) systemic symptoms not attributable to another disease.
Time frame: 12 weeks
Indian Takayasu's Arteritis Activity Score 2010 (ITAS2010
ITAS2010 contains 44 items with 33 features arising from the cardiovascular system. Seven key items are weighted to score 2 and all others score 1 only.
Time frame: 12 weeks
Childhood Health Assessment Questionaire (CHAQ)
The Childhood Health Assessment Questionnaire (CHAQ) is a disease specific health instrument that measures functional ability in daily living activities in children
Time frame: 12 weeks
Physical activity levels
The level of physical activity of patients will be measured using the Actigraph GT3x® triaxial accelerometer (Actigraph®).
Time frame: 12 weeks
Fatigue severity scale FSS
The Fatigue severity scale will be used to monitor the change in fatigue in response to the intervention. For each item, you must tick from 1 totally disagree to 7 agree totally. The total number of points may vary from 9 to 63, and it is established that values equal to or greater than 28 are indicative of the presence of fatigue
Time frame: 12 weeks
Quality of life
as assessed by Short-Form-36
Time frame: 12 weeks
Hypotension after acute exercise session
after maximal aerobic capacity, the blood pressure will be will be measured in the four limbs, both arms and legs, every fifteen minutes, for an hour.
Time frame: 12 weeks
Plan to share: No
Started Mar 2018 (actual). Primary completion is estimated for Dec 2019, 21 months after the start.
How these figures are worked out, and which studies are left out of them.
This study is status unknown, as verified in Apr 2018. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.