Clinical trial NCT04415827: Energy Supply in Athletes and Untrained Persons With Bronchopulmonary Diseases
Official title: Study of Energy Supply in Athletes and Untrained Persons With Diseases of the Bronchopulmonary System
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Community-acquired Pneumonia
Bronchitis
Chronic Obstructive Pulmonary Disease
Acute Respiratory Infection
Keywords: sports medicine
bicycle ergometry
bronchopulmonary diseases
spiroergometry
Lead sponsor: I.M. Sechenov First Moscow State Medical University
Sponsor class: OTHER
First posted: 2020-06-04
Enrollment: 170
Sex: ALL
Minimum age (years): 17
Maximum age (years): 25
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief 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 of the volume and intensity of physical activity in training and competitive processes.

Detailed description: 1. 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.
2. 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.
3. 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.

Eligibility criteria: Inclusion Criteria:

1. the presence of written informed consent of the patient to participate in the study;
2. 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;
3. untrained individuals (men and women) with a diagnosis of community-acquired pneumonia / bronchitis / chronic obstructive pulmonary disease / acute respiratory viral infection;
4. age 17 - 25 years.

Exclusion Criteria:

1. refusal of the patient from further participation in the study;
2. non-compliance with treatment recommendations and regimen.

Primary outcomes:
measure: Change of the respiratory system function at different periods of the bronchopulmonary disease
timeFrame: 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.
measure: Change of the cardiovascular system function at different periods of the bronchopulmonary disease
timeFrame: 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:
measure: Change of electrical activity of the heart at different periods of the bronchopulmonary disease
timeFrame: 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.
measure: Change of pulmonary ventilation at different periods of the bronchopulmonary disease
timeFrame: 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.
measure: Change of pulmonary gas exchange at different periods of the bronchopulmonary disease
timeFrame: 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.
Other outcomes:
Locations:
city: Moscow
country: Russian Federation
facility: Sechenov University
Study officials:
affiliation: I.M. Sechenov First Moscow State Medical University
name: Viktoria S Moskvichyova
role: STUDY_CHAIR
References: