Physical Training in Patients With Relapsing Polychondritis

Study Overview
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Brief Summary
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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
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Impact of physical training in patients with relapsing polychondritis.

Official Title
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Physical Training in Patients With Relapsing Polychondritis

Conditions
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Physical Activity

Intervention / Treatment
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* Other: Physical training


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Interventional Model Description: Patients will submitted to physical training (12-weeks, twice/week)
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Patients<br>Patients will be submitted to physical training (12-weeks, twice/week) | Other: Physical training<br> <br> * Other names: Exercises;|
| Active Comparator: Control group<br>Healthy individuals will be submitted to physical training (12-weeks, twice/week) | Other: Physical training<br> <br> * Other names: Exercises;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 
| Healthy Assessment Questionnaire (HAQ) | Especific questionnaire to assess the quality of life. Pontuaction: 0.00-3.00 | 12 weeks | 
| Functional muscle tests | Muscle function will be evaluated through the TUG and the TST tests | 12 weeks | 
| 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 |