Clinical Trial: Physical Training in Patients With Relapsing Polychondritis

Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Interventional

Official Title: Physical Training in Patients With Relapsing Polychondritis

Brief Summary: Physical training may improve physical capacity and health parameters in various systemic autoimmune diseases. Therefore, the present study will assess the role of an exercise training program in patients with relapsing polychondritis.

Detailed Summary: Impact of physical training in patients with relapsing polychondritis.
Sponsor: University of Sao Paulo

Current Primary Outcome: Cardiopulmonary test [ Time Frame: 12 weeks ]

Patients will undertake a maximal graded exercise test on a treadmill, with increments in velocity and grade at every minute until volitional exhaustion. VO2peak will be considered as the average of the final 30 s of the test. Ventilatory threshold (VAT) will be determined when ventilatory equivalent for VO2 (VE/VO2) increased without a concomitant increase in ventilatory equivalent for carbon dioxide (VE/VCO2). Respiratory compensation point (RCP) will be determined when VE/VO2 and VE/VCO2 increased simultaneously.


Original Primary Outcome: Same as current

Current Secondary Outcome:

  • Strength muscle tests [ Time Frame: 12 weeks ]
    The dynamic 1-RM for the leg-press and the bench-press exercises, arm curl (with the dominant arm), and isometric strength (assessed by handgrip, with the dominant arm) will be assessed at baseline and after the intervention.
  • Healthy Assessment Questionnaire (HAQ) [ Time Frame: 12 weeks ]
    Especific questionnaire to assess the quality of life. Pontuaction: 0.00-3.00
  • Functional muscle tests [ Time Frame: 12 weeks ]
    Muscle function will be evaluated through the TUG and the TST tests
  • Muscle biopsy [ Time Frame: 12 weeks ]
    After local anesthesia, a cutaneous incision will be made in lateral thigh face. The biopsy will be done using the Bergstrom needle. Histological (hematoxylin and eosin)/immunohistochemical (CD4, CD8, CD68, CD20, C5b-9, MHCI, MHCII, CD31) analysis will be performed in muscle samples (at baseline and after 12 weeks) in all patients (present study)


Original Secondary Outcome:

  • Strength muscle tests [ Time Frame: 12 weeks ]
    The dynamic 1-RM for the leg-press and the bench-press exercises, arm curl (with the dominant arm), and isometric strength (assessed by handgrip, with the dominant arm) will be assessed at baseline and after the intervention.
  • Healthy Assessment Questionnaire (HAQ) [ Time Frame: 12 weeks ]
    Especific questionnaire to assess the quality of life. Pontuaction: 0.00-3.00
  • Functional muscle tests [ Time Frame: 12 weeks ]
    Muscle function will be evaluated through the TUG and the TST tests
  • Muscle biopsy (vastus lateralis muscle) [ Time Frame: 12 weeks ]
    After local anesthesia, a cutaneous incision will be made in lateral thigh face. The biopsy will be done using the Bergstrom needle. Histological/immunohistochemical analysis will be performed in muscle samples.


Information By: University of Sao Paulo

Dates:
Date Received: March 10, 2017
Date Started: January 2017
Date Completion: January 2020
Last Updated: March 24, 2017
Last Verified: March 2017