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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03092141
Other study ID # MYO-HCFMUSP-04
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date January 2017
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

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.


Description:

Impact of physical training in patients with relapsing polychondritis.


Recruitment information / eligibility

Status Completed
Enrollment 10
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 and older
Eligibility Inclusion Criteria: - Fullfill the classification criteria of McADAM et al. (1976) - Using prednisone = 0.5 mg/kg/day in the last three months - Sedentary Exclusion Criteria: - Disease relapsing - Overlapping disease - Chronic and/or current infections (viral, bacterial or fungal) - Patients undergoing major surgery within six months before the study - With commitment to ambulation (joint affection in limbs) - Smoking - Diabetes mellitus

Study Design


Related Conditions & MeSH terms


Intervention

Other:
Physical training


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 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. 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. 12 weeks
Secondary Strength muscle tests 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. 12 weeks
Secondary Healthy Assessment Questionnaire (HAQ) Especific questionnaire to assess the quality of life. Pontuaction: 0.00-3.00 12 weeks
Secondary Functional muscle tests Muscle function will be evaluated through the TUG and the TST tests 12 weeks
Secondary Muscle biopsy 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) 12 weeks
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