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Trial record 46 of 10500 for:    strength

Aerobic Capacity and Strength Exercise in Takayasu's Arteritis

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ClinicalTrials.gov Identifier: NCT03750929
Recruitment Status : Recruiting
First Posted : November 22, 2018
Last Update Posted : November 22, 2018
Sponsor:
Information provided by (Responsible Party):
Samuel Katsuyuki Shinjo, PhD, University of Sao Paulo

Brief 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

Condition or disease Intervention/treatment Phase
Physical Activity Takayasu Arteritis Other: Combined acute physical exercises (strength and aerobic) Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 44 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Investigator)
Primary Purpose: Other
Official Title: Aerobic Capacity and Strength Exercise in Takayasu's Arteritis: Impact on Clinical, Laboratory and Vascular Parameters
Actual Study Start Date : October 1, 2018
Estimated Primary Completion Date : November 1, 2020
Estimated Study Completion Date : November 1, 2021

Resource links provided by the National Library of Medicine


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)




Primary Outcome Measures :
  1. Security of acute session of combined physical exercises [ Time Frame: One week before the exercises ]
    Acute aerobic with strength muscle test exercise


Secondary Outcome Measures :
  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).



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Ages Eligible for Study:   18 Years to 50 Years   (Adult)
Sexes Eligible for Study:   All
Gender Based Eligibility:   Yes
Gender Eligibility Description:   Participant eligibility is based on self-representation of gender identity
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Classification criteria of Takayasu's arteritis
  • Sedentarism

Exclusion Criteria:

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03750929


Contacts
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Contact: Samuel K Shinjo 1130617176 samuel.shinjo@gmail.com

Locations
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Brazil
Samuel Katsuyuki Shinjo Recruiting
Sao Paulo, Brazil, 01246903
Contact: Samuel K Shinjo, PhD    55-11-3061-7176    samuel.shinjo@gmail.com   
Sub-Investigator: Alexandre M Santos         
Sponsors and Collaborators
University of Sao Paulo
Investigators
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Principal Investigator: Samuel K Shinjo Universidade de Sao Paulo - Rheumatology Division

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Responsible Party: Samuel Katsuyuki Shinjo, PhD, Professor, PhD, University of Sao Paulo
ClinicalTrials.gov Identifier: NCT03750929     History of Changes
Other Study ID Numbers: MYO-HCFMUSP-05
First Posted: November 22, 2018    Key Record Dates
Last Update Posted: November 22, 2018
Last Verified: November 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Samuel Katsuyuki Shinjo, PhD, University of Sao Paulo:
Takayasus's arteritis
Physical exercises
Rheumatic diseases
Systemic vasculitis
Additional relevant MeSH terms:
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Arteritis
Takayasu Arteritis
Aortic Arch Syndromes
Vasculitis
Vascular Diseases
Cardiovascular Diseases
Aortic Diseases
Skin Diseases, Vascular
Skin Diseases