- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03092141
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
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
-
-
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Sao Paulo, Brazil, 01246903
- Samuel Katsuyuki Shinjo
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-
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)
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Other Names:
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Active Comparator: Control group
Healthy individuals will be submitted to physical training (12-weeks, twice/week)
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Other Names:
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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.
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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.
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12 weeks
|
Healthy Assessment Questionnaire (HAQ)
Time Frame: 12 weeks
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Especific questionnaire to assess the quality of life.
Pontuaction: 0.00-3.00
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12 weeks
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Functional muscle tests
Time Frame: 12 weeks
|
Muscle function will be evaluated through the TUG and the TST tests
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12 weeks
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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)
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12 weeks
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Samuel K Shinjo, PhD, University of São 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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