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Aerobic Capacity and Strength Exercise in Takayasu's Arteritis

Primary Purpose

Physical Activity, Takayasu Arteritis

Status
Completed
Phase
Not Applicable
Locations
Brazil
Study Type
Interventional
Intervention
Combined acute physical exercises (strength and aerobic)
Sponsored by
University of Sao Paulo
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Physical Activity focused on measuring Takayasus's arteritis, Physical exercises, Rheumatic diseases, Systemic vasculitis

Eligibility Criteria

18 Years - 50 Years (Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • Classification criteria of Takayasu's arteritis
  • Sedentarism

Exclusion Criteria:

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

Sites / Locations

  • Samuel Katsuyuki Shinjo

Arms of the Study

Arm 1

Arm 2

Arm Type

No Intervention

Experimental

Arm Label

Non physical exercises

Physical exercises

Arm Description

Patients will not be submmitted to combined acute physical exercises (strength and aerobic)

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.

Outcomes

Primary Outcome Measures

Security of acute session of combined physical exercises
Acute aerobic with strength muscle test exercise

Secondary Outcome Measures

Healthy Assessment Questionnaire (HAQ)
Especific questionnaire to assess the quality of life. Pontuaction: 0.00 (best) - 3.00 (worst).
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
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
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.
Laboratory analysis (Erythrocyte rate sedimentation)
Erythrocyte rate sedimentation (reference: < 20 mm/ first hour) will be analyzed to evaluate degree of disease activity
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).
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).
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).
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).

Full Information

First Posted
November 16, 2018
Last Updated
April 29, 2021
Sponsor
University of Sao Paulo
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1. Study Identification

Unique Protocol Identification Number
NCT03750929
Brief Title
Aerobic Capacity and Strength Exercise in Takayasu's Arteritis
Official Title
Aerobic Capacity and Strength Exercise in Takayasu's Arteritis: Impact on Clinical, Laboratory and Vascular Parameters
Study Type
Interventional

2. Study Status

Record Verification Date
April 2021
Overall Recruitment Status
Completed
Study Start Date
October 1, 2018 (Actual)
Primary Completion Date
April 29, 2021 (Actual)
Study Completion Date
April 29, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Sao Paulo

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Physical Activity, Takayasu Arteritis
Keywords
Takayasus's arteritis, Physical exercises, Rheumatic diseases, Systemic vasculitis

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Investigator
Allocation
Randomized
Enrollment
12 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Non physical exercises
Arm Type
No Intervention
Arm Description
Patients will not be submmitted to combined acute physical exercises (strength and aerobic)
Arm Title
Physical exercises
Arm Type
Experimental
Arm Description
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.
Intervention Type
Other
Intervention Name(s)
Combined acute physical exercises (strength and aerobic)
Intervention Description
Patients will be submmitted to combined acute physical exercises (strength and aerobic)
Primary Outcome Measure Information:
Title
Security of acute session of combined physical exercises
Description
Acute aerobic with strength muscle test exercise
Time Frame
One week before the exercises
Secondary Outcome Measure Information:
Title
Healthy Assessment Questionnaire (HAQ)
Description
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)
Title
Laboratory analysis (Serum levels of the protein C-reactive)
Description
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)
Title
Indian Takayasu's Arteritis Activity Score (ITAS 2010)
Description
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)
Title
Cardiopulmonary test
Description
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)
Title
Laboratory analysis (Erythrocyte rate sedimentation)
Description
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)
Title
Strength muscle tests 1
Description
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)
Title
Strength muscle tests 2
Description
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)
Title
Strength muscle tests 3
Description
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)
Title
Strength muscle tests 4
Description
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)

10. Eligibility

Sex
All
Gender Based
Yes
Gender Eligibility Description
Participant eligibility is based on self-representation of gender identity
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Samuel K Shinjo
Organizational Affiliation
Universidade de Sao Paulo - Rheumatology Division
Official's Role
Principal Investigator
Facility Information:
Facility Name
Samuel Katsuyuki Shinjo
City
Sao Paulo
ZIP/Postal Code
01246903
Country
Brazil

12. IPD Sharing Statement

Plan to Share IPD
Undecided

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Aerobic Capacity and Strength Exercise in Takayasu's Arteritis

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