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Takayasu's ArteritisNCT03494062

Exercise in Juvenile Takayasu Disease

A study testing Exercise in people with Takayasu's Arteritis, run by University of Sao Paulo at 1 site in Brazil.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 7 to 25 years
Conditions the study is for
Takayasu's Arteritis
What is being tested?
Exercise
Could I receive a placebo?
No, everyone receives an active treatment
How many people
21 participants
Where
1 siteBrazil
Study dates
5 Mar 2018to 30 Dec 2019
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 7 to 25 years
  • All sexes
  • No healthy volunteers
  • Child, Adult

Who may be able to join

  • diagnosis of juvenile Takayasu disease

Who cannot join

  • cardiac and renal insufficiency
  • physical limitation hampering exercise training
  • non-controlled metabolic disorders
  • associated chronic diseases (last 6 months)

Trial locations and contacts

1 site in 1 country.

Camilla CA Astley, Masters contact

5511964721104

camilla.astley@gmail.com

Brazil1 site, 1 recruiting

  • University of Sao Paulo

    São Paulo, Castanho, 05303-000

    Camilla Astley, 551126618022, camilla.astley@gmail.com

    Recruiting

Other trials in Brazil

About this study

Official title: 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.

Read the 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.

Being tested
Exercise
Medical subject headings
Takayasu Arteritis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • ExerciseBehavioural

    Home-based exercise training

Study groups in NCT03494062
Study groupRoleWhat they receive
ExerciseExperimentalHome-based exercise intervention
Receives: Behavioral: Exercise
ControlNo interventionUsual care

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Arterial inflammation

    as assessed by positron emission tomography - magnetic ressonance (PET-MR)

    Measured: 12 weeks

  2. Blood inflammatory markers

    interleukin-6, interleukin 10, interleukin-12

    Measured: 12 weeks

  3. Blood inflammatory marker

    C-reactive protein

    Measured: 12 weeks

  4. velocity sedimentation rate

    velocity sedimentation rate

    Measured: 12 weeks

Secondary outcomes (14)

  1. Maximal aerobic capacity

    as assessed by maximal cardiopulmonary test

    Measured: 12 weeks

  2. Body composition

    Lean, fat and bone mass, as assessed by dual energy x-ray absorptiometry

    Measured: 12 weeks

  3. 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.

    Measured: 12 weeks

  4. 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.

    Measured: 12 weeks

  5. Isometric strength

    handgrip test

    Measured: 12 weeks

  6. 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

    Measured: 12 weeks

  7. 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.

    Measured: 12 weeks

  8. 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.

    Measured: 12 weeks

  9. 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.

    Measured: 12 weeks

  10. 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

    Measured: 12 weeks

  11. Physical activity levels

    The level of physical activity of patients will be measured using the Actigraph GT3x® triaxial accelerometer (Actigraph®).

    Measured: 12 weeks

  12. 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

    Measured: 12 weeks

  13. Quality of life

    as assessed by Short-Form-36

    Measured: 12 weeks

  14. 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.

    Measured: 12 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted11 Apr 2018
  2. Study start5 Mar 2018
  3. Primary completion30 Dec 2019 (estimated)
  4. Study completion30 Dec 2019 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Care provider
Enrolment
21 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03494062
Sponsor's protocol ID
Takayasu&Exercise
Status last verified
Apr 2018
First submitted
5 Mar 2018
Last updated
11 Apr 2018
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

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.

    PubMed 34394103

Questions about this trial

What is this clinical trial studying?

A study testing Exercise in people with Takayasu's Arteritis, run by University of Sao Paulo at 1 site in Brazil.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 11 Apr 2018. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Brazil. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Camilla CA Astley, Masters (5511964721104, camilla.astley@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Arterial inflammation (time frame: 12 weeks). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03494062, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Apr 2018.

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