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CompletedNCT03750929Updated Apr 30, 2021

Aerobic Capacity and Strength Exercise in Takayasu's Arteritis

An interventional study of Combined acute physical exercises (strength and aerobic) in Physical Activity and Takayasu Arteritis, sponsored by University of Sao Paulo. Completed at 1 site in Brazil. Open to participants aged 18 Years to 50 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2021-04-30.

Sponsored by University of Sao Paulo · Not applicable, Interventional, and Other

Phase
Not applicable
Study type
Interventional
Enrollment
12
Allocation
Randomized
Ages
18 Years to 50 Years
Sex
All
01

Study 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

Read the 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.

02

Conditions studied

  • Physical Activity
  • Takayasu Arteritis

Keywords

  • Takayasus's arteritis
  • Physical exercises
  • Rheumatic diseases
  • Systemic vasculitis
03

In context

Arteritis

135 studies on the registry are indexed under Arteritis; 26 are open to participants now.

This study's enrollment of 12 is below the median of 44 across 65 interventional studies indexed under Arteritis.

Browse Arteritis studies →

Lead sponsor

University of Sao Paulo is the lead sponsor of 1,005 studies on the registry; 90 are open to participants now.

Of its 7 completed or terminated interventional studies of FDA-regulated products, 0 (0%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 50 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Inclusion criteria

  • Classification criteria of Takayasu's arteritis
  • Sedentarism

Exclusion criteria

Exclusion Criteria:

  • Peripherical arterial diseases
  • Non-controlled cardiovascular diseases
  • Neurological diseases
  • Patients with walking problem
05

Study design

Phase
Not applicable
Primary purpose
Other
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Investigator)
Enrollment
12 participants (actual)

Study arms

  • 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.

    Other: Combined acute physical exercises (strength and aerobic)

Interventions

  • OtherCombined acute physical exercises (strength and aerobic)

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

06

What researchers measure

Primary outcomes

  1. Security of acute session of combined physical exercises

    Acute aerobic with strength muscle test exercise

    Time frame: One week before the exercises

Secondary outcomes

  1. Healthy Assessment Questionnaire (HAQ)

    Especific questionnaire to assess the quality of life. Pontuaction: 0.00 (best) - 3.00 (worst).

    Time frame: Twice (within 1 week before and until 30 minutes after acute combined physical exercises)

  2. Laboratory analysis (Serum levels of the protein C-reactive)

    Protein C-reactive (\< 5 mg/dL or not) will be analyzed to evaluate degree of disease activity

    Time frame: Twice (within 1 week before and until 30 minutes after acute combined physical exercises)

  3. Indian Takayasu's Arteritis Activity Score (ITAS 2010)

    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

    Time frame: Twice (within 1 week before and until 30 minutes after acute combined physical exercises)

  4. Cardiopulmonary test

    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.

    Time frame: Once (within 1 week before acute combined physical exercises)

  5. Laboratory analysis (Erythrocyte rate sedimentation)

    Erythrocyte rate sedimentation (reference: \< 20 mm/ first hour) will be analyzed to evaluate degree of disease activity

    Time frame: Twice (within 1 week before and until 30 minutes after acute combined physical exercises)

  6. Strength muscle tests 1

    The dynamic 1 maximum repetition for the bench-press exercises. The value of maximum repetition depending on each patient (unit: Newton).

    Time frame: Twice (within 1 week before and until 30 minutes after acute combined physical exercises)

  7. Strength muscle tests 2

    The dynamic 1 maximum repetition for the leg-press press exercises. The value of maximum repetition depending on each patient (unit: Newton).

    Time frame: Twice (within 1 week before and until 30 minutes after acute combined physical exercises)

  8. Strength muscle tests 3

    The dynamic 1 maximum repetition for the arm curl (with the dominant arm). The value of maximum repetition depending on each patient (unit: Newton).

    Time frame: Twice (within 1 week before and until 30 minutes after acute combined physical exercises)

  9. Strength muscle tests 4

    Isometric strength (assessed by handgrip, with the dominant arm) will be assessed. The value of maximum strenght will depend on each patient (unit: Newton).

    Time frame: Twice (within 1 week before and until 30 minutes after acute combined physical exercises)

07

Study locations

1 site
  • Samuel Katsuyuki Shinjo
    Sao Paulo, 01246903, Brazil
08

References and documents

Individual participant data

Plan to share: Undecided

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Apr 30, 2021, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT03750929
Lead sponsor
University of Sao Paulo
Responsible party
Samuel Katsuyuki Shinjo, PhD (Professor, PhD, University of Sao Paulo) — Principal investigator
First posted
Nov 23, 2018
Start date
Oct 1, 2018
Primary completion
Apr 29, 2021
Completion
Apr 29, 2021
Last update
Apr 30, 2021

Study contacts

Samuel K Shinjo
principal investigator · Universidade de Sao Paulo - Rheumatology Division

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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