Exercise in Juvenile Takayasu Disease
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT03494062|
Recruitment Status : Recruiting
First Posted : April 11, 2018
Last Update Posted : April 11, 2018
|Condition or disease||Intervention/treatment||Phase|
|Takayasu's Arteritis||Behavioral: Exercise||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||21 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Single (Care Provider)|
|Official Title:||Exercise in Juvenile Takayasu Disease: a Randomized Controlled Trial|
|Actual Study Start Date :||March 5, 2018|
|Estimated Primary Completion Date :||December 30, 2019|
|Estimated Study Completion Date :||December 30, 2019|
Home-based exercise intervention
Home-based exercise training
No Intervention: Control
- 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
- 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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03494062
|Contact: Camilla CA Astley, Mastersfirstname.lastname@example.org|
|University of Sao Paulo||Recruiting|
|São Paulo, Castanho, Brazil, 05303-000|
|Contact: Camilla Astley 551126618022 email@example.com|
|Principal Investigator:||Bruno BG Gualano, Professor||University of Sao Paulo|