Clinical trial NCT03750929: Aerobic Capacity and Strength Exercise in Takayasu's Arteritis
Official title: Aerobic Capacity and Strength Exercise in Takayasu's Arteritis: Impact on Clinical, Laboratory and Vascular Parameters
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Physical Activity
Takayasu Arteritis
Keywords: Takayasus's arteritis
Physical exercises
Rheumatic diseases
Systemic vasculitis
Lead sponsor: University of Sao Paulo
Sponsor class: OTHER
First posted: 2018-11-23
Enrollment: 12
Sex: ALL
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: Takayasu's arteritis is a primary systemic vasculitis that affects large vessels and their main branches. The objectives of the present study were to assess: a) the aerobic capacity (CA); b) security of the acute strength exercise session; c) correlation between CA, as well as strength exercise session, with demographic, clinical, therapeutic, comorbid parameters, and presence and degree of vascular damage; d) serum levels of the cytokines

Detailed description: Takayasu's arteritis (TA) is a primary systemic vasculitis that affects large vessels and their main branches. It mainly affects young women. Blood vessel inflammation may result in stenosis, occlusions, ectasias and/or aneurysms and, consequently, difference of blood pressure between limbs and vascular claudication. Aerobic capacity (CA) is the measure of oxygen uptake, transport and use by the body, characterizing the individual's ability to perform activity. It is also a tool that can predict cardiovascular diseases. Our group has been a pioneer in demonstrating that CA is decreased in the small sample of the young women with TA. In addition, the safety and efficacy of aerobic exercises in this sample of patients were shown, as well as the influence of these sessions on the pro-inflammatory and angiogenic serum levels of the cytokines. However, due to the small samples, it was not possible to correlate CA with clinical and laboratory parameters and also with the presence of vascular damage. Moreover, to date, no studies have evaluated securityof an acute strength exercise session in TA.Therefore, thes objectives of the present study were to evaluate: a) the CA; b) security of the acute strength exercise session; c) correlation between CA, as well as strength exercise session, with demographic, clinical, therapeutic, comorbid parameters, and presence and degree of vascular damage; d) serum levels of the cytokine.

Eligibility criteria: Inclusion Criteria:

* Classification criteria of Takayasu's arteritis
* Sedentarism

Exclusion Criteria:

* Peripherical arterial diseases
* Non-controlled cardiovascular diseases
* Neurological diseases
* Patients with walking problem

Primary outcomes:
measure: Security of acute session of combined physical exercises
timeFrame: One week before the exercises
Secondary outcomes:
measure: Healthy Assessment Questionnaire (HAQ)
timeFrame: Twice (within 1 week before and until 30 minutes after acute combined physical exercises)
measure: Laboratory analysis (Serum levels of the protein C-reactive)
timeFrame: Twice (within 1 week before and until 30 minutes after acute combined physical exercises)
measure: Indian Takayasu's Arteritis Activity Score (ITAS 2010)
timeFrame: Twice (within 1 week before and until 30 minutes after acute combined physical exercises)
measure: Cardiopulmonary test
timeFrame: Once (within 1 week before acute combined physical exercises)
measure: Laboratory analysis (Erythrocyte rate sedimentation)
timeFrame: Twice (within 1 week before and until 30 minutes after acute combined physical exercises)
measure: Strength muscle tests 1
timeFrame: Twice (within 1 week before and until 30 minutes after acute combined physical exercises)
measure: Strength muscle tests 2
timeFrame: Twice (within 1 week before and until 30 minutes after acute combined physical exercises)
measure: Strength muscle tests 3
timeFrame: Twice (within 1 week before and until 30 minutes after acute combined physical exercises)
measure: Strength muscle tests 4
timeFrame: Twice (within 1 week before and until 30 minutes after acute combined physical exercises)
Other outcomes:
Locations:
city: Sao Paulo
country: Brazil
facility: Samuel Katsuyuki Shinjo
Study officials:
affiliation: Universidade de Sao Paulo - Rheumatology Division
name: Samuel K Shinjo
role: PRINCIPAL_INVESTIGATOR
References: