Community-acquired PneumoniaNCT04415827
Energy Supply in Athletes and Untrained Persons With Bronchopulmonary Diseases
A study testing bicycle ergometry test with spiroergometry in people with Community-acquired Pneumonia and Bronchitis, run by I.M. Sechenov First Moscow State Medical University at 1 site in Russia.
Trial summary
Study of the energy supply of bicycle ergometric load in athletes and untrained persons with bronchopulmonary diseases (community-acquired pneumonia, bronchitis, chronic obstructive pulmonary disease and acute respiratory viral infections, to justify the timing of the resumption of training, as well as determination… Read more about this study
- Who is it for?
- Ages 17 to 25 years
- Conditions the study is for
- Community-acquired Pneumonia, Bronchitis, Chronic Obstructive Pulmonary Disease
- What is being tested?
- bicycle ergometry test with spiroergometry
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 170 participants
- Where
- 1 siteRussia
- Study dates
- 23 May 2020to 1 Dec 2022
- 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 17 to 25 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- the presence of written informed consent of the patient to participate in the study;
- athletes (men and women) with a diagnosis of community-acquired pneumonia / bronchitis / chronic obstructive pulmonary disease / acute respiratory viral infection on days 28-31 from the onset of the disease, i.e. in the stage of clinical recovery;
- untrained individuals (men and women) with a diagnosis of community-acquired pneumonia / bronchitis / chronic obstructive pulmonary disease / acute respiratory viral infection;
- age 17 - 25 years.
Who cannot join
- refusal of the patient from further participation in the study;
- non-compliance with treatment recommendations and regimen.
Trial locations and contacts
1 site in 1 country.
Russia1 site, 1 recruiting
- Recruiting
Sechenov University
Moscow, 119991
Viktoria S Moskvichyova, +79251290922, moskvicheva_viktoria@mail.ru
About this study
Official title: Study of Energy Supply in Athletes and Untrained Persons With Diseases of the Bronchopulmonary System
Study of the energy supply of bicycle ergometric load in athletes and untrained persons with bronchopulmonary diseases (community-acquired pneumonia, bronchitis, chronic obstructive pulmonary disease and acute respiratory viral infections, to justify the timing of the resumption of training, as well as determination of the volume and intensity of physical activity in training and competitive processes.
Read the detailed description
- The aim of the study is to assess energy supply of bicycle ergometric load in athletes and untrained persons who have suffered diseases of the bronchopulmonary system (community-acquired pneumonia, bronchitis, chronic obstructive pulmonary disease and acute respiratory viral infections, to justify the timing of the resumption of training, as well as determining the volume and the intensity of physical activity in the training and competitive processes.
- In addition to a comprehensive general clinical, radiological (for community-acquired pneumonia) and laboratory examination, all the subjects under study will undergo special studies: spirography and spiroergometry, electrocardiography (ECG), and bicycle ergometry.
- The main indicators of the functional state of the cardio-respiratory system of the study participants are indicators of the function of external respiration and gas exchange, recorded in the initial state, after load and in the recovery period of 10 and 30 minutes.
Patients with diseases of the bronchopulmonary system will receive treatment according to generally accepted standards of drug treatment.
- Conditions
- Community-acquired Pneumonia, Bronchitis, Chronic Obstructive Pulmonary Disease, Acute Respiratory Infection
- Being tested
- bicycle ergometry test with spiroergometry
- Keywords
- sports medicine, bicycle ergometry, bronchopulmonary diseases, spiroergometry
- Medical subject headings
- Community-Acquired Pneumonia, Bronchitis, Pulmonary Disease, Chronic Obstructive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
bicycle ergometry test with spiroergometryDiagnostic test
The 1st testing will be carried out on the 28-31th day of the disease, which corresponds to the period of the expected normalization of temperature, improvement of well-being, positive dynamics of radiological (with community-acquired pneumonia) and laboratory data, the 2nd test - after 3 months, the 3rd - after 6 months and IV - after 12 months.
Load testing will be carried out on a bicycle ergometer with an initial power of 25 watts with a further increase of 25 watts every 3 minutes. The cessation of the load will be carried out upon the appearance of signs set forth in the recommendations of the World Health Organization Expert Committee (1970)
| Study group | Role | What they receive |
|---|---|---|
| Athletes with community-acquired pneumonia | Experimental | man and women, athletes, age 17-25, patients with community-acquired pneumonia Receives: Diagnostic Test: bicycle ergometry test with spiroergometry |
| Untrained people with community-acquired pneumonia | Experimental | man and women, untrained people, age 17-25, patients with community-acquired pneumonia Receives: Diagnostic Test: bicycle ergometry test with spiroergometry |
| Athletes with bronchitis | Experimental | man and women, athletes, age 17-25, patients with bronchitis Receives: Diagnostic Test: bicycle ergometry test with spiroergometry |
| Untrained people with bronchitis | Experimental | man and women, untrained people, age 17-25, patients with bronchitis Receives: Diagnostic Test: bicycle ergometry test with spiroergometry |
| Athletes with chronic obstructive pulmonary disease | Experimental | man and women, athletes, age 17-25, patients with with chronic obstructive pulmonary disease Receives: Diagnostic Test: bicycle ergometry test with spiroergometry |
| Untrained people with chronic obstructive pulmonary disease | Experimental | man and women, untrained people, age 17-25, patients with with chronic obstructive pulmonary disease Receives: Diagnostic Test: bicycle ergometry test with spiroergometry |
| Athletes with acute respiratory infections | Experimental | man and women, athletes, age 17-25, patients with acute respiratory infections Receives: Diagnostic Test: bicycle ergometry test with spiroergometry |
| Untrained people with acute respiratory infections | Experimental | man and women, untrained people, age 17-25, patients with acute respiratory infections Receives: Diagnostic Test: bicycle ergometry test with spiroergometry |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change of the respiratory system function at different periods of the bronchopulmonary disease
assesment a change of respiratory rate using stress test machine "Cardiovit" in the initial state, after cycling and in the recovery period for 10 and 30 minutes.
Measured: The 1st test will be carried out on the 28-31th day of the disease, the 2nd test - after 3 months, III - after 6 months and IV - after 12 months.
Change of the cardiovascular system function at different periods of the bronchopulmonary disease
assesment a change of heart rate using stress test machine "Cardiovit" in the initial state, after cycling and in the recovery period for 10 and 30 minutes.
Measured: The 1st test will be carried out on the 28-31th day of the disease, the 2nd test - after 3 months, III - after 6 months and IV - after 12 months.
Secondary outcomes (3)
Change of electrical activity of the heart at different periods of the bronchopulmonary disease
assesment a change of the electrical activity of the heart using stress test machine "Cardiovit", recording changes on an ECG (segment ST) during cycling.
Measured: The 1st test will be carried out on the 28-31th day of the disease, the 2nd test - after 3 months, III - after 6 months and IV - after 12 months.
Change of pulmonary ventilation at different periods of the bronchopulmonary disease
assesment a change of the pulmonary ventilation using stress test machine "Cardiovit", determining tidal volume (l/min) in the initial state, after cycling and in the recovery period for 10 and 30 minutes.
Measured: The 1st test will be carried out on the 28-31th day of the disease, the 2nd test - after 3 months, III - after 6 months and IV - after 12 months.
Change of pulmonary gas exchange at different periods of the bronchopulmonary disease
assesment a change of oxygen uptake (ml/min) using stress test machine "Cardiovit" in the initial state, after cycling and in the recovery period for 10 and 30 minutes.
Measured: The 1st test will be carried out on the 28-31th day of the disease, the 2nd test - after 3 months, III - after 6 months and IV - after 12 months.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Jun 2020
- Study start23 May 2020
- Primary completion22 Dec 2021 (estimated)
- Study completion1 Dec 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Community-acquired PneumoniaStudies 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 170 participants (estimated)
Sponsor and investigators
- Lead sponsor
- I.M. Sechenov First Moscow State Medical University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Viktoria S Moskvichyova, Study chair, I.M. Sechenov First Moscow State Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04415827
- Sponsor's protocol ID
- 520122019
- Status last verified
- May 2020
- First submitted
- 17 Apr 2020
- Last updated
- 4 Jun 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: prohibited by Local Ethics Committee of "I.M. Sechenov First Moscow State Medical University"
Study at a glance
From the registry record, last updated by the sponsor on 4 Jun 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study of Energy Supply in Athletes and Untrained Persons With Diseases of the Bronchopulmonary System
- ClinicalTrials.gov ID
- NCT04415827
- Acronym / sponsor ID
- 520122019
- Conditions
- Community-acquired Pneumonia, Bronchitis, Chronic Obstructive Pulmonary Disease, Acute Respiratory Infection
- Keywords
- sports medicine, bicycle ergometry, bronchopulmonary diseases, spiroergometry
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 170 participants (estimated)
- Lead sponsor
- I.M. Sechenov First Moscow State Medical UniversityUniversity, hospital or other
- Study start
- 23 May 2020 (actual)
- Primary completion
- 22 Dec 2021 (estimated)
- Study completion
- 1 Dec 2022 (estimated)
- First posted
- 4 Jun 2020 (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.
Study of the energy supply of bicycle ergometric load in athletes and untrained persons with bronchopulmonary diseases (community-acquired pneumonia, bronchitis, chronic obstructive pulmonary disease and acute respiratory viral infections, to justify the timing of the resumption of training, as well as determination of the volume and intensity of physical activity in training and competitive processes.
Detailed description
- The aim of the study is to assess energy supply of bicycle ergometric load in athletes and untrained persons who have suffered diseases of the bronchopulmonary system (community-acquired pneumonia, bronchitis, chronic obstructive pulmonary disease and acute respiratory viral infections, to justify the timing of the resumption of training, as well as determining the volume and the intensity of physical activity in the training and competitive processes.
- In addition to a comprehensive general clinical, radiological (for community-acquired pneumonia) and laboratory examination, all the subjects under study will undergo special studies: spirography and spiroergometry, electrocardiography (ECG), and bicycle ergometry.
- The main indicators of the functional state of the cardio-respiratory system of the study participants are indicators of the function of external respiration and gas exchange, recorded in the initial state, after load and in the recovery period of 10 and 30 minutes.
Patients with diseases of the bronchopulmonary system will receive treatment according to generally accepted standards of drug treatment.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 8
| Arm | Type | Receives |
|---|---|---|
| Athletes with community-acquired pneumonia | Experimental | Diagnostic Test: bicycle ergometry test with spiroergometryman and women, athletes, age 17-25, patients with community-acquired pneumonia |
| Untrained people with community-acquired pneumonia | Experimental | Diagnostic Test: bicycle ergometry test with spiroergometryman and women, untrained people, age 17-25, patients with community-acquired pneumonia |
| Athletes with bronchitis | Experimental | Diagnostic Test: bicycle ergometry test with spiroergometryman and women, athletes, age 17-25, patients with bronchitis |
| Untrained people with bronchitis | Experimental | Diagnostic Test: bicycle ergometry test with spiroergometryman and women, untrained people, age 17-25, patients with bronchitis |
| Athletes with chronic obstructive pulmonary disease | Experimental | Diagnostic Test: bicycle ergometry test with spiroergometryman and women, athletes, age 17-25, patients with with chronic obstructive pulmonary disease |
| Untrained people with chronic obstructive pulmonary disease | Experimental | Diagnostic Test: bicycle ergometry test with spiroergometryman and women, untrained people, age 17-25, patients with with chronic obstructive pulmonary disease |
| Athletes with acute respiratory infections | Experimental | Diagnostic Test: bicycle ergometry test with spiroergometryman and women, athletes, age 17-25, patients with acute respiratory infections |
| Untrained people with acute respiratory infections | Experimental | Diagnostic Test: bicycle ergometry test with spiroergometryman and women, untrained people, age 17-25, patients with acute respiratory infections |
Who may qualify
- Ages
- 17 to 25 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (4 listed)
- the presence of written informed consent of the patient to participate in the study;
- athletes (men and women) with a diagnosis of community-acquired pneumonia / bronchitis / chronic obstructive pulmonary disease / acute respiratory viral infection on days 28-31 from the onset of the disease, i.e. in the stage of clinical recovery;
- untrained individuals (men and women) with a diagnosis of community-acquired pneumonia / bronchitis / chronic obstructive pulmonary disease / acute respiratory viral infection;
- age 17 - 25 years.
Key exclusion criteria (2 listed)
- refusal of the patient from further participation in the study;
- non-compliance with treatment recommendations and regimen.
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 |
|---|---|---|
| bicycle ergometry test with spiroergometryThe 1st testing will be carried out on the 28-31th day of the disease, which corresponds to the period of the expected normalization of temperature, improvement of well-being, positive dynamics of radiological (with community-acquired pneumonia) and laboratory data, the 2nd test - after 3 months, the 3rd - after 6 months and IV - after 12 months. Load testing will be carried out on a bicycle ergometer with an initial power of 25 watts with a further increase of 25 watts every 3 minutes. The cessation of the load will be carried out upon the appearance of signs set forth in the recommendations of the World Health Organization Expert Committee (1970) | Diagnostic test | Athletes with acute respiratory infections, Athletes with bronchitis, Athletes with chronic obstructive pulmonary disease, Athletes with community-acquired pneumonia, Untrained people with acute respiratory infections, Untrained people with bronchitis, Untrained people with chronic obstructive pulmonary disease, Untrained people with community-acquired pneumonia |
Primary outcome
Change of the respiratory system function at different periods of the bronchopulmonary disease
Time frame: The 1st test will be carried out on the 28-31th day of the disease, the 2nd test - after 3 months, III - after 6 months and IV - after 12 months.
assesment a change of respiratory rate using stress test machine "Cardiovit" in the initial state, after cycling and in the recovery period for 10 and 30 minutes.
Change of the cardiovascular system function at different periods of the bronchopulmonary disease
Time frame: The 1st test will be carried out on the 28-31th day of the disease, the 2nd test - after 3 months, III - after 6 months and IV - after 12 months.
assesment a change of heart rate using stress test machine "Cardiovit" in the initial state, after cycling and in the recovery period for 10 and 30 minutes.
3 secondary outcomes
Change of electrical activity of the heart at different periods of the bronchopulmonary disease
Time frame: The 1st test will be carried out on the 28-31th day of the disease, the 2nd test - after 3 months, III - after 6 months and IV - after 12 months.
Change of pulmonary ventilation at different periods of the bronchopulmonary disease
Time frame: The 1st test will be carried out on the 28-31th day of the disease, the 2nd test - after 3 months, III - after 6 months and IV - after 12 months.
Change of pulmonary gas exchange at different periods of the bronchopulmonary disease
Time frame: The 1st test will be carried out on the 28-31th day of the disease, the 2nd test - after 3 months, III - after 6 months and IV - after 12 months.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Jun 2020.
- Individual participant dataSharing planned: No. prohibited by Local Ethics Committee of "I.M. Sechenov First Moscow State Medical University"
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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.
Viktoria S Moskvichyova study chair
I.M. Sechenov First Moscow State Medical University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing bicycle ergometry test with spiroergometry in people with Community-acquired Pneumonia and Bronchitis, run by I.M. Sechenov First Moscow State Medical University at 1 site in Russia.
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 4 inclusion and 2 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: status not confirmed, as of the sponsor's last update on 4 Jun 2020. 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 Russia. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Viktoria S Moskvichyova (+79251290922, moskvicheva_viktoria@mail.ru), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change of the respiratory system function at different periods of the bronchopulmonary disease (time frame: The 1st test will be carried out on the 28-31th day of the disease, the 2nd test - after 3 months, III - after 6 months and IV - after 12 months.). The study lists 2 primary outcomes in all. 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 4 Jun 2020.