Aerobic Capacity and Strength Exercise in Takayasu's Arteritis

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

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

Study Overview

• Status: Completed
• Conditions: Physical Activity; Takayasu Arteritis
• Intervention / Treatment: Other: Combined acute physical exercises (strength and aerobic)

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.

• Study Type: Interventional
• Enrollment (Actual): 12
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Brazil
  • Sao Paulo, Brazil, 01246903
    • Samuel Katsuyuki Shinjo

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 50 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Classification criteria of Takayasu's arteritis
• Sedentarism

Exclusion Criteria:

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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); Patients will be submmitted to combined acute physical exercises (strength and aerobic)

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Healthy Assessment Questionnaire (HAQ)	Especific questionnaire to assess the quality of life. Pontuaction: 0.00 (best) - 3.00 (worst).	Twice (within 1 week before and until 30 minutes after acute combined physical exercises)
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	Twice (within 1 week before and until 30 minutes after acute combined physical exercises)
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	Twice (within 1 week before and until 30 minutes after acute combined physical exercises)
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.	Once (within 1 week before acute combined physical exercises)
Laboratory analysis (Erythrocyte rate sedimentation)	Erythrocyte rate sedimentation (reference: < 20 mm/ first hour) will be analyzed to evaluate degree of disease activity	Twice (within 1 week before and until 30 minutes after acute combined physical exercises)
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).	Twice (within 1 week before and until 30 minutes after acute combined physical exercises)
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).	Twice (within 1 week before and until 30 minutes after acute combined physical exercises)
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).	Twice (within 1 week before and until 30 minutes after acute combined physical exercises)
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).	Twice (within 1 week before and until 30 minutes after acute combined physical exercises)

Collaborators and Investigators

• Sponsor: University of Sao Paulo
• Investigators: Principal Investigator: Samuel K Shinjo, Universidade de Sao Paulo - Rheumatology Division

Study record dates

Study Major Dates

• Study Start (Actual): October 1, 2018
• Primary Completion (Actual): April 29, 2021
• Study Completion (Actual): April 29, 2021

Study Registration Dates

• First Submitted: November 16, 2018
• First Submitted That Met QC Criteria: November 21, 2018
• First Posted (Actual): November 23, 2018

Study Record Updates

• Last Update Posted (Actual): April 30, 2021
• Last Update Submitted That Met QC Criteria: April 29, 2021
• Last Verified: April 1, 2021

More Information

Terms related to this study

• Keywords: Systemic vasculitis; Rheumatic diseases; Takayasus's arteritis; Physical exercises
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Skin Diseases; Vasculitis; Skin Diseases, Vascular; Aortic Diseases; Arteritis; Takayasu Arteritis; Aortic Arch Syndromes
• Other Study ID Numbers: MYO-HCFMUSP-05

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No