Aerobic Capacity and Strength Exercise in Takayasu's Arteritis

Physical Activity Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03750929
• Other study ID #: MYO-HCFMUSP-05
• Status: Completed
• Phase: N/A
• Start date: October 1, 2018
• Est. completion date: April 29, 2021

Study information

• Verified date: April 2021
• Source: University of Sao Paulo
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 12
• Est. completion date: April 29, 2021
• Est. primary completion date: April 29, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 50 Years

Eligibility

Inclusion Criteria:

• Classification criteria of Takayasu's arteritis
• Sedentarism

Exclusion Criteria:

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

Related Conditions & MeSH terms

• Arteritis
• Physical Activity
• Takayasu Arteritis

Intervention

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

Locations

Country	Name	City	State
Brazil	Samuel Katsuyuki Shinjo	Sao Paulo

Sponsors (1)

Lead Sponsor	Collaborator
University of Sao Paulo

Country where clinical trial is conducted

Brazil, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Security of acute session of combined physical exercises	Acute aerobic with strength muscle test exercise	One week before the exercises
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)