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Exercise in Juvenile Takayasu Disease

Primary Purpose

Takayasu's Arteritis

Status
Unknown status
Phase
Not Applicable
Locations
Brazil
Study Type
Interventional
Intervention
Exercise
Sponsored by
University of Sao Paulo
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Takayasu's Arteritis

Eligibility Criteria

7 Years - 25 Years (Child, Adult)All SexesDoes not accept healthy volunteers

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)

Sites / Locations

  • University of Sao PauloRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Exercise

Control

Arm Description

Home-based exercise intervention

Usual care

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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

Full Information

First Posted
March 5, 2018
Last Updated
April 10, 2018
Sponsor
University of Sao Paulo
Collaborators
Federal University of São Paulo
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1. Study Identification

Unique Protocol Identification Number
NCT03494062
Brief Title
Exercise in Juvenile Takayasu Disease
Official Title
Exercise in Juvenile Takayasu Disease: a Randomized Controlled Trial
Study Type
Interventional

2. Study Status

Record Verification Date
April 2018
Overall Recruitment Status
Unknown status
Study Start Date
March 5, 2018 (Actual)
Primary Completion Date
December 30, 2019 (Anticipated)
Study Completion Date
December 30, 2019 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Sao Paulo
Collaborators
Federal University of São Paulo

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Takayasu's Arteritis

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Care Provider
Allocation
Randomized
Enrollment
21 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Exercise
Arm Type
Experimental
Arm Description
Home-based exercise intervention
Arm Title
Control
Arm Type
No Intervention
Arm Description
Usual care
Intervention Type
Behavioral
Intervention Name(s)
Exercise
Intervention Description
Home-based exercise training
Primary Outcome Measure Information:
Title
Arterial inflammation
Description
as assessed by positron emission tomography - magnetic ressonance (PET-MR)
Time Frame
12 weeks
Title
Blood inflammatory markers
Description
interleukin-6, interleukin 10, interleukin-12
Time Frame
12 weeks
Title
Blood inflammatory marker
Description
C-reactive protein
Time Frame
12 weeks
Title
velocity sedimentation rate
Description
velocity sedimentation rate
Time Frame
12 weeks
Secondary Outcome Measure Information:
Title
Maximal aerobic capacity
Description
as assessed by maximal cardiopulmonary test
Time Frame
12 weeks
Title
Body composition
Description
Lean, fat and bone mass, as assessed by dual energy x-ray absorptiometry
Time Frame
12 weeks
Title
Timed stands test
Description
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
Title
timed-up-and-go test
Description
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
Title
Isometric strength
Description
handgrip test
Time Frame
12 weeks
Title
Maximal strength test
Description
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
Title
The Paediatric Vasculitis Activity Score (PVAS)
Description
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
Title
National Institute of Health (NIH)
Description
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
Title
Indian Takayasu's Arteritis Activity Score 2010 (ITAS2010
Description
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
Title
Childhood Health Assessment Questionaire (CHAQ)
Description
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
Title
Physical activity levels
Description
The level of physical activity of patients will be measured using the Actigraph GT3x® triaxial accelerometer (Actigraph®).
Time Frame
12 weeks
Title
Fatigue severity scale FSS
Description
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
Title
Quality of life
Description
as assessed by Short-Form-36
Time Frame
12 weeks
Title
Hypotension after acute exercise session
Description
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
7 Years
Maximum Age & Unit of Time
25 Years
Accepts Healthy Volunteers
No
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)
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Camilla CA Astley, Masters
Phone
5511964721104
Email
camilla.astley@gmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Bruno BG Gualano, Professor
Organizational Affiliation
University of Sao Paulo
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Sao Paulo
City
São Paulo
State/Province
Castanho
ZIP/Postal Code
05303-000
Country
Brazil
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Camilla Astley
Phone
551126618022
Email
camilla.astley@gmail.com

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
34394103
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.
Results Reference
derived

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Exercise in Juvenile Takayasu Disease

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