Physical Training in Patients With Relapsing Polychondritis

April 29, 2021 updated by: Samuel Katsuyuki Shinjo, PhD, University of Sao Paulo
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Impact of physical training in patients with relapsing polychondritis.

Study Type

Interventional

Enrollment (Actual)

10

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Brazil
      • Sao Paulo, Brazil, 01246903
        • Samuel Katsuyuki Shinjo

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Patients
Patients will be submitted to physical training (12-weeks, twice/week)
Other: Physical training
Other Names:
  • Exercises
Active Comparator: Control group
Healthy individuals will be submitted to physical training (12-weeks, twice/week)
Other: Physical training
Other Names:
  • Exercises

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
12 weeks

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Sao Paulo

Investigators

  • Principal Investigator: Samuel K Shinjo, PhD, University of Sao Paulo

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 1, 2017

Primary Completion (Actual)

April 29, 2021

Study Completion (Actual)

April 29, 2021

Study Registration Dates

First Submitted

March 10, 2017

First Submitted That Met QC Criteria

March 21, 2017

First Posted (Actual)

March 27, 2017

Study Record Updates

Last Update Posted (Actual)

April 30, 2021

Last Update Submitted That Met QC Criteria

April 29, 2021

Last Verified

April 1, 2021

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • MYO-HCFMUSP-04

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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