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Exercise in Juvenile Takayasu Disease

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ClinicalTrials.gov Identifier: NCT03494062
Recruitment Status : Recruiting
First Posted : April 11, 2018
Last Update Posted : April 11, 2018
Sponsor:
Collaborator:
Federal University of São Paulo
Information provided by (Responsible Party):
Bruno Gualano, University of Sao Paulo

Tracking Information
First Submitted Date  ICMJE March 5, 2018
First Posted Date  ICMJE April 11, 2018
Last Update Posted Date April 11, 2018
Actual Study Start Date  ICMJE March 5, 2018
Estimated Primary Completion Date December 30, 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: April 10, 2018)
  • Arterial inflammation [ Time Frame: 12 weeks ]
    as assessed by positron emission tomography - magnetic ressonance (PET-MR)
  • Blood inflammatory markers [ Time Frame: 12 weeks ]
    interleukin-6, interleukin 10, interleukin-12
  • Blood inflammatory marker [ Time Frame: 12 weeks ]
    C-reactive protein
  • velocity sedimentation rate [ Time Frame: 12 weeks ]
    velocity sedimentation rate
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE
 (submitted: April 10, 2018)
  • Maximal aerobic capacity [ Time Frame: 12 weeks ]
    as assessed by maximal cardiopulmonary test
  • Body composition [ Time Frame: 12 weeks ]
    Lean, fat and bone mass, as assessed by dual energy x-ray absorptiometry
  • Timed stands test [ Time Frame: 12 weeks ]
    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.
  • timed-up-and-go test [ Time Frame: 12 weeks ]
    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.
  • Isometric strength [ Time Frame: 12 weeks ]
    handgrip test
  • Maximal strength test [ Time Frame: 12 weeks ]
    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
  • The Paediatric Vasculitis Activity Score (PVAS) [ Time Frame: 12 weeks ]
    The final PVAS is a clinical index of 64 manifestations of active vasculitis, divided into five domains: general, cutaneous, cardiovascular, abdominal and renal.
  • National Institute of Health (NIH) [ Time Frame: 12 weeks ]
    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.
  • Indian Takayasu's Arteritis Activity Score 2010 (ITAS2010 [ Time Frame: 12 weeks ]
    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.
  • Childhood Health Assessment Questionaire (CHAQ) [ Time Frame: 12 weeks ]
    The Childhood Health Assessment Questionnaire (CHAQ) is a disease specific health instrument that measures functional ability in daily living activities in children
  • Physical activity levels [ Time Frame: 12 weeks ]
    The level of physical activity of patients will be measured using the Actigraph GT3x® triaxial accelerometer (Actigraph®).
  • Fatigue severity scale FSS [ Time Frame: 12 weeks ]
    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
  • Quality of life [ Time Frame: 12 weeks ]
    as assessed by Short-Form-36
  • Hypotension after acute exercise session [ Time Frame: 12 weeks ]
    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.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Exercise in Juvenile Takayasu Disease
Official Title  ICMJE 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  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Care Provider)
Primary Purpose: Treatment
Condition  ICMJE Takayasu's Arteritis
Intervention  ICMJE Behavioral: Exercise
Home-based exercise training
Study Arms  ICMJE
  • Experimental: Exercise
    Home-based exercise intervention
    Intervention: Behavioral: Exercise
  • No Intervention: Control
    Usual care
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: April 10, 2018)
21
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE December 30, 2019
Estimated Primary Completion Date December 30, 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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)
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 7 Years to 25 Years   (Child, Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Camilla CA Astley, Masters 5511964721104 camilla.astley@gmail.com
Listed Location Countries  ICMJE Brazil
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03494062
Other Study ID Numbers  ICMJE Takayasu&Exercise
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Bruno Gualano, University of Sao Paulo
Study Sponsor  ICMJE University of Sao Paulo
Collaborators  ICMJE Federal University of São Paulo
Investigators  ICMJE
Principal Investigator: Bruno BG Gualano, Professor University of Sao Paulo
PRS Account University of Sao Paulo
Verification Date April 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP