Physical Training in Patients With Relapsing Polychondritis

NCT03092141 | Completed

• 1 other identifier: MYO-HCFMUSP-04
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

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.

Conditions

Physical Activity

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (4)

• Strength muscle tests

  12 weeks

• Healthy Assessment Questionnaire (HAQ)

  12 weeks

• Functional muscle tests

  12 weeks

• Muscle biopsy

  12 weeks

Study Arms (2)

Patients

ACTIVE COMPARATOR

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

Other: Physical training

Control group

ACTIVE COMPARATOR

Healthy individuals will be submitted to physical training (12-weeks, twice/week)

Other: Physical training

Interventions

Physical training OTHER

Also known as: Exercises

Control group; Patients

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Fullfill the classification criteria of McADAM et al. (1976)
• Using prednisone ≤ 0.5 mg/kg/day in the last three months
• Sedentary

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Sao Paulo: lead

Study Sites (1)

Samuel Katsuyuki Shinjo

São Paulo, 01246903, Brazil

Location

MeSH Terms

Conditions

Motor Activity

Interventions

Physical Conditioning, Human; Exercise

Condition Hierarchy (Ancestors)

Behavior

Intervention Hierarchy (Ancestors)

Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Study Officials

• Samuel K Shinjo, PhD

  University of Sao Paulo

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

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

Study Record Dates

• First Submitted: March 10, 2017
• First Posted: March 27, 2017
• Study Start: January 1, 2017
• Primary Completion: April 29, 2021
• Study Completion: April 29, 2021
• Last Updated: April 30, 2021

Record last verified: 2021-04

Data Sharing

• IPD Sharing: Will not share

Locations

BR (1)