Clinical Trials Logo

Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03750929
Other study ID # MYO-HCFMUSP-05
Secondary ID
Status Completed
Phase N/A
First received
Last updated
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
Health authority
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

Study Design


Related Conditions & MeSH terms


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)
See also
  Status Clinical Trial Phase
Active, not recruiting NCT05661799 - Persistence of Physical Activity in People With Type 2 Diabetes Over Time. N/A
Active, not recruiting NCT03903874 - Testing Scalable, IVR-supported Cancer Prevention Interventions in the Rural Alabama Black Belt N/A
Recruiting NCT03662438 - HOPE (Home-based Oxygen [Portable] and Exercise) for Patients on Long Term Oxygen Therapy (LTOT) N/A
Withdrawn NCT04540523 - Home-Based Exergaming Intervention N/A
Recruiting NCT03250000 - Changes in Microcirculation and Functional Status During Exacerbation of COPD N/A
Recruiting NCT05563805 - Exploring Virtual Reality Adventure Training Exergaming N/A
Completed NCT03430648 - Is Tau Protein Linked to Mobility Function?
Completed NCT05019482 - Intervention Program Among University Student to Promote Physical Activity and Reduce the Sedentary Time N/A
Completed NCT03253406 - Health Wearables and College Student Health N/A
Not yet recruiting NCT05985460 - A Very Brief Intervention to Increase the Intention to Practice Physical Activity N/A
Completed NCT03700736 - The Healthy Moms Study: Comparison of a Post-Partum Weight Loss Intervention Delivered Via Facebook or In-Person Groups N/A
Completed NCT03380143 - Whole-of-Community Youth Population Physical Activity N/A
Completed NCT03170921 - Psychophysiological Characterization of Different Capoeira Performances in Experienced Individuals N/A
Completed NCT04973813 - Active Choice Intervention About Physical Activity for Physically Inactive Adults N/A
Completed NCT03982095 - Survey on Lifestyle, Perceived Barriers and Development of Change in Patients With Prostate Cancer
Completed NCT03271112 - Frailty Prevention in Elders From Reunion Island N/A
Completed NCT05670223 - Healthy Activities Improve Lives N/A
Completed NCT04894929 - Comprehensive Geriatric Assessment in the Monitoring of Functional Improvement N/A
Recruiting NCT04578067 - Empowering Immigrant Women for Active and Healthy Lifestyle N/A
Completed NCT03297567 - Physical Therapy Guidelines For Hospitalized Elderly N/A