Aerobic Capacity and Strength Exercise in Takayasu’s Arteritis

Overview

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

Full Title of Study: “Aerobic Capacity and Strength Exercise in Takayasu’s Arteritis: Impact on Clinical, Laboratory and Vascular Parameters”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Other
    • Masking: Single (Investigator)
  • Study Primary Completion Date: April 29, 2021

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.

Interventions

  • Other: Combined acute physical exercises (strength and aerobic)
    • Patients will be submmitted to combined acute physical exercises (strength and aerobic)

Arms, Groups and Cohorts

  • No Intervention: Non physical exercises
    • Patients will not be submmitted to combined acute physical exercises (strength and aerobic)
  • Experimental: 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.

Clinical Trial Outcome Measures

Primary Measures

  • Security of acute session of combined physical exercises
    • Time Frame: One week before the exercises
    • Acute aerobic with strength muscle test exercise

Secondary Measures

  • Healthy Assessment Questionnaire (HAQ)
    • Time Frame: Twice (within 1 week before and until 30 minutes after acute combined physical exercises)
    • Especific questionnaire to assess the quality of life. Pontuaction: 0.00 (best) – 3.00 (worst).
  • Laboratory analysis (Serum levels of the protein C-reactive)
    • Time Frame: Twice (within 1 week before and until 30 minutes after acute combined physical exercises)
    • Protein C-reactive (< 5 mg/dL or not) will be analyzed to evaluate degree of disease activity
  • Indian Takayasu’s Arteritis Activity Score (ITAS 2010)
    • Time Frame: Twice (within 1 week before and until 30 minutes after acute combined physical exercises)
    • Analyzing TA disease activity. Questionnaire with 44 items with 33 features arising from the cardiovascular system. Seven key items are weighted to score 2 and all others score 1 only. Activity was defined as ITAS 2010 score of ≥ 2 YES items
  • Cardiopulmonary test
    • Time Frame: Once (within 1 week before acute combined physical exercises)
    • Patients will undertake a maximal graded exercise test on a treadmill, with increments in velocity and grade at every minute until volitional exhaustion (VO2) (mL/kg/minutes). VO2peak will be considered as the average of the final 30 seconds of the test.
  • Laboratory analysis (Erythrocyte rate sedimentation)
    • Time Frame: Twice (within 1 week before and until 30 minutes after acute combined physical exercises)
    • Erythrocyte rate sedimentation (reference: < 20 mm/ first hour) will be analyzed to evaluate degree of disease activity
  • Strength muscle tests 1
    • Time Frame: Twice (within 1 week before and until 30 minutes after acute combined physical exercises)
    • The dynamic 1 maximum repetition for the bench-press exercises. The value of maximum repetition depending on each patient (unit: Newton).
  • Strength muscle tests 2
    • Time Frame: Twice (within 1 week before and until 30 minutes after acute combined physical exercises)
    • The dynamic 1 maximum repetition for the leg-press press exercises. The value of maximum repetition depending on each patient (unit: Newton).
  • Strength muscle tests 3
    • Time Frame: Twice (within 1 week before and until 30 minutes after acute combined physical exercises)
    • The dynamic 1 maximum repetition for the arm curl (with the dominant arm). The value of maximum repetition depending on each patient (unit: Newton).
  • Strength muscle tests 4
    • Time Frame: Twice (within 1 week before and until 30 minutes after acute combined physical exercises)
    • Isometric strength (assessed by handgrip, with the dominant arm) will be assessed. The value of maximum strenght will depend on each patient (unit: Newton).

Participating in This Clinical Trial

Inclusion Criteria

  • Classification criteria of Takayasu's arteritis – Sedentarism Exclusion Criteria:

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

Gender Eligibility: All

Participant eligibility is based on self-representation of gender identity

Minimum Age: 18 Years

Maximum Age: 50 Years

Are Healthy Volunteers Accepted: Accepts Healthy Volunteers

Investigator Details

  • Lead Sponsor
    • University of Sao Paulo
  • Provider of Information About this Clinical Study
    • Principal Investigator: Samuel Katsuyuki Shinjo, PhD, Professor, PhD – University of Sao Paulo
  • Overall Official(s)
    • Samuel K Shinjo, Principal Investigator, Universidade de Sao Paulo – Rheumatology Division

Clinical trials entries are delivered from the US National Institutes of Health and are not reviewed separately by this site. Please see the identifier information above for retrieving further details from the government database.

At TrialBulletin.com, we keep tabs on over 200,000 clinical trials in the US and abroad, using medical data supplied directly by the US National Institutes of Health. Please see the About and Contact page for details.