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Completed

NCT Number: NCT03092141

Physical Training in Patients With Relapsing Polychondritis

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.

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Key information

Conditions

Physical Activity Behavior Motor Activity

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Samuel Katsuyuki Shinjo

São Paulo, 01246903, Brazil

About this study

Impact of physical training in patients with relapsing polychondritis.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Physical training

Other

Other names: Exercises

Primary outcomes

  1. 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.

Secondary outcomes

  1. 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.

  2. Healthy Assessment Questionnaire (HAQ)

    Time frame: 12 weeks

    Especific questionnaire to assess the quality of life. Pontuaction: 0.00-3.00

  3. Functional muscle tests

    Time frame: 12 weeks

    Muscle function will be evaluated through the TUG and the TST tests

  4. 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)

Sponsors and collaborators

Lead sponsor

University of Sao Paulo

Other

Registry information

Important dates

Study start
2017
Primary completion
2021
Study completion
2021
First posted
Mar 27, 2017
Registry last updated
Apr 30, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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