Physical Training in Patients With Relapsing Polychondritis

Physical Activity Clinical Trial

Official title:

Physical Training in Patients With Relapsing Polychondritis

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03092141
• Other study ID #: MYO-HCFMUSP-04
• Status: Completed
• Phase: N/A
• Start date: January 2017
• Est. completion date: April 29, 2021

Study information

• Verified date: April 2021
• Source: University of Sao Paulo
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Description:

Impact of physical training in patients with relapsing polychondritis.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 10
• Est. completion date: April 29, 2021
• Est. primary completion date: April 29, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Physical Activity

Intervention

Other:
• Physical training

Locations

Country	Name	City	State
Brazil	Samuel Katsuyuki Shinjo	Sao Paulo

Sponsors (1)

Lead Sponsor	Collaborator
University of Sao Paulo

Country where clinical trial is conducted

Brazil, 

Outcome

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