Physical ActivityNCT03092141
Physical Training in Patients With Relapsing Polychondritis
A study testing Physical training in people with Physical Activity, run by University of Sao Paulo at 1 site in Brazil.
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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Physical Activity
- What is being tested?
- Physical training
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteBrazil
- Study dates
- Jan 2017to 29 Apr 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Fullfill the classification criteria of McADAM et al. (1976)
- Using prednisone ≤ 0.5 mg/kg/day in the last three months
- Sedentary
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the detailed description
Impact of physical training in patients with relapsing polychondritis.
- Conditions
- Physical Activity
- Being tested
- Physical training
- Medical subject headings
- Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Physical trainingOther
Also called Exercises
| Study group | Role | What they receive |
|---|---|---|
| Patients | Active comparator | Patients will be submitted to physical training (12-weeks, twice/week) Receives: Other: Physical training |
| Control group | Active comparator | Healthy individuals will be submitted to physical training (12-weeks, twice/week) Receives: Other: Physical training |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 12 weeks
Secondary outcomes (4)
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.
Measured: 12 weeks
Healthy Assessment Questionnaire (HAQ)
Especific questionnaire to assess the quality of life. Pontuaction: 0.00-3.00
Measured: 12 weeks
Functional muscle tests
Muscle function will be evaluated through the TUG and the TST tests
Measured: 12 weeks
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)
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Mar 2017
- Study startJan 2017
- Primary completion29 Apr 2021
- Study completion29 Apr 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Physical ActivityStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Model description
- Patients will submitted to physical training (12-weeks, twice/week)
- Masking
- None (open label)
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Sao Paulo
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Samuel Katsuyuki Shinjo, PhD, University of Sao Paulo
- Investigators
- Samuel K Shinjo, PhD, Principal investigator, University of Sao Paulo
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03092141
- Sponsor's protocol ID
- MYO-HCFMUSP-04
- Status last verified
- Apr 2021
- First submitted
- 10 Mar 2017
- Last updated
- 30 Apr 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Apr 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Physical Training in Patients With Relapsing Polychondritis
- ClinicalTrials.gov ID
- NCT03092141
- Acronym / sponsor ID
- MYO-HCFMUSP-04
- Conditions
- Physical Activity
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 10 participants (actual)
- Lead sponsor
- University of Sao PauloUniversity, hospital or other
- Study start
- Jan 2017 (actual)
- Primary completion
- 29 Apr 2021 (actual)
- Study completion
- 29 Apr 2021 (actual)
- First posted
- 27 Mar 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Impact of physical training in patients with relapsing polychondritis.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Patients will submitted to physical training (12-weeks, twice/week)
| Arm | Type | Receives |
|---|---|---|
| Patients | Active comparator | Other: Physical trainingPatients will be submitted to physical training (12-weeks, twice/week) |
| Control group | Active comparator | Other: Physical trainingHealthy individuals will be submitted to physical training (12-weeks, twice/week) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Fullfill the classification criteria of McADAM et al. (1976)
- Using prednisone ≤ 0.5 mg/kg/day in the last three months
- Sedentary
Key exclusion criteria (7 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Physical trainingAlso: Exercises | Other | Control group, Patients |
Primary outcome
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.
4 secondary outcomes
Strength muscle tests
Time frame: 12 weeks
Healthy Assessment Questionnaire (HAQ)
Time frame: 12 weeks
Functional muscle tests
Time frame: 12 weeks
Muscle biopsy
Time frame: 12 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Apr 2021.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Samuel K Shinjo, PhD principal investigator
University of Sao Paulo
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Physical training in people with Physical Activity, run by University of Sao Paulo at 1 site in Brazil.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 30 Apr 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Brazil. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Cardiopulmonary test (time frame: 12 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Apr 2021.