NCT03750929

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
12

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Oct 2018

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2018

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

November 16, 2018

Completed
7 days until next milestone

First Posted

Study publicly available on registry

November 23, 2018

Completed
2.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 29, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 29, 2021

Completed
Last Updated

April 30, 2021

Status Verified

April 1, 2021

Enrollment Period

2.6 years

First QC Date

November 16, 2018

Last Update Submit

April 29, 2021

Conditions

Physical ActivityTakayasu Arteritis

Keywords

Takayasus's arteritisPhysical exercisesRheumatic diseasesSystemic vasculitis

Outcome Measures

Primary Outcomes (1)

  • Security of acute session of combined physical exercises

    Acute aerobic with strength muscle test exercise

    One week before the exercises

Secondary Outcomes (9)

  • Healthy Assessment Questionnaire (HAQ)

    Twice (within 1 week before and until 30 minutes after acute combined physical exercises)

  • Laboratory analysis (Serum levels of the protein C-reactive)

    Twice (within 1 week before and until 30 minutes after acute combined physical exercises)

  • Indian Takayasu's Arteritis Activity Score (ITAS 2010)

    Twice (within 1 week before and until 30 minutes after acute combined physical exercises)

  • Cardiopulmonary test

    Once (within 1 week before acute combined physical exercises)

  • Laboratory analysis (Erythrocyte rate sedimentation)

    Twice (within 1 week before and until 30 minutes after acute combined physical exercises)

  • +4 more secondary outcomes

Study Arms (2)

Non physical exercises

NO INTERVENTION

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

Physical exercises

EXPERIMENTAL

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)

Interventions

Combined acute physical exercises (strength and aerobic)OTHER

Patients will be submmitted to combined acute physical exercises (strength and aerobic)

Physical exercises

Eligibility Criteria

Age18 Years - 50 Years
Sexall(Gender-based eligibility)
Gender Eligibility DetailsParticipant eligibility is based on self-representation of gender identity
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Classification criteria of Takayasu's arteritis
  • Sedentarism

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Samuel Katsuyuki Shinjo

São Paulo, 01246903, Brazil

Location

MeSH Terms

Conditions

Motor ActivityTakayasu ArteritisRheumatic DiseasesSystemic Vasculitis

Condition Hierarchy (Ancestors)

BehaviorAortic Arch SyndromesAortic DiseasesVascular DiseasesCardiovascular DiseasesArteritisVasculitisSkin Diseases, VascularSkin DiseasesSkin and Connective Tissue DiseasesMusculoskeletal DiseasesConnective Tissue Diseases

Study Officials

  • Samuel K Shinjo

    Universidade de Sao Paulo - Rheumatology Division

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
INVESTIGATOR
Purpose
OTHER
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor, PhD

Study Record Dates

First Submitted

November 16, 2018

First Posted

November 23, 2018

Study Start

October 1, 2018

Primary Completion

April 29, 2021

Study Completion

April 29, 2021

Last Updated

April 30, 2021

Record last verified: 2021-04

Locations

BR(1)