Exercise in Juvenile Takayasu Disease
1 other identifier
interventional
21
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Mar 2018
Typical duration for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
March 5, 2018
CompletedStudy Start
First participant enrolled
March 5, 2018
CompletedFirst Posted
Study publicly available on registry
April 11, 2018
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 30, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
December 30, 2019
CompletedApril 11, 2018
April 1, 2018
1.8 years
March 5, 2018
April 10, 2018
Conditions
Outcome Measures
Primary Outcomes (4)
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 Outcomes (14)
Maximal aerobic capacity
12 weeks
Body composition
12 weeks
Timed stands test
12 weeks
timed-up-and-go test
12 weeks
Isometric strength
12 weeks
- +9 more secondary outcomes
Study Arms (2)
Exercise
EXPERIMENTALHome-based exercise intervention
Control
NO INTERVENTIONUsual care
Interventions
Eligibility Criteria
You may qualify if:
- diagnosis of juvenile Takayasu disease
You may not qualify if:
- cardiac and renal insufficiency
- physical limitation hampering exercise training
- non-controlled metabolic disorders
- associated chronic diseases (last 6 months)
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- University of Sao Paulolead
- Federal University of São Paulocollaborator
Study Sites (1)
University of Sao Paulo
São Paulo, Castanho, 05303-000, Brazil
Related Publications (1)
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.
PMID: 34394103DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Bruno BG Gualano, Professor
University of Sao Paulo
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- CARE PROVIDER
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Professor
Study Record Dates
First Submitted
March 5, 2018
First Posted
April 11, 2018
Study Start
March 5, 2018
Primary Completion
December 30, 2019
Study Completion
December 30, 2019
Last Updated
April 11, 2018
Record last verified: 2018-04
Data Sharing
- IPD Sharing
- Will not share