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Physical Training in Patients With Relapsing Polychondritis

Physical Training in Patients With Relapsing Polychondritis

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03092141
Enrollment
10
Registered
2017-03-27
Start date
2017-01-31
Completion date
2021-04-29
Last updated
2021-04-30

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Physical Activity

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.

Interventions

OTHERPhysical training

Sponsors

University of Sao Paulo
Lead SponsorOTHER

Study design

Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE

Intervention model description

Patients will submitted to physical training (12-weeks, twice/week)

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
Cardiopulmonary test12 weeksPatients 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

MeasureTime frameDescription
Strength muscle tests12 weeksThe 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 weeksEspecific questionnaire to assess the quality of life. Pontuaction: 0.00-3.00
Functional muscle tests12 weeksMuscle function will be evaluated through the TUG and the TST tests
Muscle biopsy12 weeksAfter 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)

Countries

Brazil

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026