Exercise in Juvenile Takayasu Disease

Exercise in Juvenile Takayasu Disease: a Randomized Controlled Trial

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.

Study Overview

• Status: Unknown
• Conditions: Takayasu's Arteritis
• Intervention / Treatment: Behavioral: Exercise

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
• Enrollment (Anticipated): 21
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Camilla CA Astley, Masters; Phone Number: 5511964721104; Email: camilla.astley@gmail.com

Study Locations

• Brazil
  • Castanho
    • São Paulo, Castanho, Brazil, 05303-000
      • Recruiting
      • University of Sao Paulo
      • Contact: Camilla Astley; Phone Number: 551126618022; Email: camilla.astley@gmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 7 years to 25 years (Child, Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: Control; Usual care
Experimental: Exercise; Home-based exercise intervention	Behavioral: Exercise; Home-based exercise training

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Arterial inflammation	as assessed by positron emission tomography - magnetic ressonance (PET-MR)	12 weeks
Blood inflammatory markers	interleukin-6, interleukin 10, interleukin-12	12 weeks
Blood inflammatory marker	C-reactive protein	12 weeks
velocity sedimentation rate	velocity sedimentation rate	12 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Maximal aerobic capacity	as assessed by maximal cardiopulmonary test	12 weeks
Body composition	Lean, fat and bone mass, as assessed by dual energy x-ray absorptiometry	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.	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.	12 weeks
Isometric strength	handgrip test	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	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.	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.	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.	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	12 weeks
Physical activity levels	The level of physical activity of patients will be measured using the Actigraph GT3x® triaxial accelerometer (Actigraph®).	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	12 weeks
Quality of life	as assessed by Short-Form-36	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.	12 weeks

Collaborators and Investigators

• Sponsor: University of Sao Paulo
• Collaborators: Federal University of São Paulo
• Investigators: Principal Investigator: Bruno BG Gualano, Professor, University of Sao Paulo

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (Actual): March 5, 2018
• Primary Completion (Anticipated): December 30, 2019
• Study Completion (Anticipated): December 30, 2019

Study Registration Dates

• First Submitted: March 5, 2018
• First Submitted That Met QC Criteria: April 10, 2018
• First Posted (Actual): April 11, 2018

Study Record Updates

• Last Update Posted (Actual): April 11, 2018
• Last Update Submitted That Met QC Criteria: April 10, 2018
• Last Verified: April 1, 2018

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Skin Diseases; Vasculitis; Skin Diseases, Vascular; Aortic Diseases; Arteritis; Takayasu Arteritis; Aortic Arch Syndromes
• Other Study ID Numbers: Takayasu&Exercise

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No