Aerobic Capacity and Strength Exercise in Takayasu's Arteritis

NCT ID: NCT03750929

Last Updated: 2021-04-30

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 12 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-10-01
• Study Completion Date: 2021-04-29

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.

Conditions

Physical Activity; Takayasu Arteritis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: OTHER
• Blinding Strategy: SINGLE

Study Groups

Non physical exercises

Patients will not be submmitted to combined acute physical exercises (strength and aerobic)

Group Type: NO_INTERVENTION

No interventions assigned to this group

Physical exercises

Patients will be submmitted to combined acute physical exercises (strength and aerobic) that consist on: supine, paddling, leg press 45º, knee extensor, flexor knee (two sets of 15 to 20 repetitions, with loads between 30% and 40% of a maximum repetition, with 30 seconds of interval). We will perform in the first exercise for upper and lower limbs, for heating, after starting the training where 4 series of 8 to 12 maximum repetitions will be performed, using the load between 70% and 80% of 1 maximum repetitions, already evaluated. The recovery between sets will be 90 seconds and between exercises will be 120 seconds.

Group Type: EXPERIMENTAL

Combined acute physical exercises (strength and aerobic)

Intervention Type: OTHER

Patients will be submmitted to combined acute physical exercises (strength and aerobic)

Interventions

Combined acute physical exercises (strength and aerobic)

Patients will be submmitted to combined acute physical exercises (strength and aerobic)

Intervention Type: OTHER

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 50 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

University of Sao Paulo

OTHER

Sponsor Role: lead

Responsible Party

Samuel Katsuyuki Shinjo, PhD

Professor, PhD

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Samuel K Shinjo

Role: PRINCIPAL_INVESTIGATOR

Universidade de Sao Paulo - Rheumatology Division

Locations

Samuel Katsuyuki Shinjo

São Paulo, , Brazil

Countries

Brazil

Other Identifiers

MYO-HCFMUSP-05

Identifier Type: -

Identifier Source: org_study_id