Skip to main content
OpenTrials
Completed

NCT Number: NCT03750929

Aerobic Capacity and Strength Exercise in Takayasu's Arteritis

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

Completed

Looking for future studies?

Notify Me

Key information

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Classification criteria of Takayasu's arteritis
  • Sedentarism

Exclusion criteria

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

Treatment and study plan

Combined acute physical exercises (strength and aerobic)

Other

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

Primary outcomes

  1. Security of acute session of combined physical exercises

    Time frame: One week before the exercises

    Acute aerobic with strength muscle test exercise

Secondary outcomes

  1. 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).

  2. 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

  3. 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

  4. 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.

  5. 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

  6. 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).

  7. 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).

  8. 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).

  9. 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).

Sponsors and collaborators

Lead sponsor

University of Sao Paulo

Other

Registry information

Official study title

Aerobic Capacity and Strength Exercise in Takayasu's Arteritis: Impact on Clinical, Laboratory and Vascular Parameters

Important dates

Study start
2018
Primary completion
2021
Study completion
2021
First posted
Nov 23, 2018
Registry last updated
Apr 30, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.