Physical Training in Patients With Relapsing Polychondritis

Not Applicable

Completed

• Conditions: Physical Activity
• Interventions: Other: Physical training

• Registration Number: NCT03092141
• Lead Sponsor: University of Sao Paulo

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 Description

Impact of physical training in patients with relapsing polychondritis.

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study Start: 2017-01
• Study First Submitted: 2017-03-10
• Study First Submitted QC: 2017-03-21
• Study First Posted: 2017-03-27
• Status Verified: 2021-04
• Primary Completion: 2021-04-29
• Study Completion: 2021-04-29
• Last Update Submitted: 2021-04-29
• Last Update Posted: 2021-04-30

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 10

Inclusion Criteria

• Fullfill the classification criteria of McADAM et al. (1976)
• Using prednisone ≤ 0.5 mg/kg/day in the last three months
• Sedentary

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Patients	Physical training	Patients will be submitted to physical training (12-weeks, twice/week)
Control group	Physical training	Healthy individuals will be submitted to physical training (12-weeks, twice/week)

Primary Outcome Measures

Name	Time	Method
Cardiopulmonary test	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.

Secondary Outcome Measures

Name	Time	Method
Strength muscle tests	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)	12 weeks	Especific questionnaire to assess the quality of life. Pontuaction: 0.00-3.00
Functional muscle tests	12 weeks	Muscle function will be evaluated through the TUG and the TST tests
Muscle biopsy	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)

Trial Locations

Locations (1)

Samuel Katsuyuki Shinjo; 🇧🇷 Sao Paulo, Brazil