Energy Supply in Athletes and Untrained Persons With Bronchopulmonary Diseases

Not Applicable

• Conditions: Community-acquired Pneumonia; Bronchitis; Chronic Obstructive Pulmonary Disease; Acute Respiratory Infection
• Interventions: Diagnostic Test: bicycle ergometry test with spiroergometry

• Registration Number: NCT04415827
• Lead Sponsor: I.M. Sechenov First Moscow State Medical University

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.

Study Timeline

• Study First Submitted: 2020-04-17
• Status Verified: 2020-05
• Study Start: 2020-05-23
• Study First Submitted QC: 2020-06-03
• Last Update Submitted: 2020-06-03
• Study First Posted: 2020-06-04
• Last Update Posted: 2020-06-04
• Primary Completion: 2021-12-22
• Study Completion: 2022-12-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 170

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Athletes with community-acquired pneumonia	bicycle ergometry test with spiroergometry	man and women, athletes, age 17-25, patients with community-acquired pneumonia
Untrained people with bronchitis	bicycle ergometry test with spiroergometry	man and women, untrained people, age 17-25, patients with bronchitis
Athletes with bronchitis	bicycle ergometry test with spiroergometry	man and women, athletes, age 17-25, patients with bronchitis
Athletes with acute respiratory infections	bicycle ergometry test with spiroergometry	man and women, athletes, age 17-25, patients with acute respiratory infections
Untrained people with community-acquired pneumonia	bicycle ergometry test with spiroergometry	man and women, untrained people, age 17-25, patients with community-acquired pneumonia
Athletes with chronic obstructive pulmonary disease	bicycle ergometry test with spiroergometry	man and women, athletes, age 17-25, patients with with chronic obstructive pulmonary disease
Untrained people with chronic obstructive pulmonary disease	bicycle ergometry test with spiroergometry	man and women, untrained people, age 17-25, patients with with chronic obstructive pulmonary disease
Untrained people with acute respiratory infections	bicycle ergometry test with spiroergometry	man and women, untrained people, age 17-25, patients with acute respiratory infections

Primary Outcome Measures

Name	Time	Method
Change of the respiratory system function at different periods of the bronchopulmonary disease	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	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.

Secondary Outcome Measures

Name	Time	Method
Change of electrical activity of the heart at different periods of the bronchopulmonary disease	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 the electrical activity of the heart using stress test machine "Cardiovit", recording changes on an ECG (segment ST) during cycling.
Change of pulmonary ventilation at different periods of the bronchopulmonary disease	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 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.
Change of pulmonary gas exchange at different periods of the bronchopulmonary disease	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 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.

Trial Locations

Locations (1)

Sechenov University; 🇷🇺 Moscow, Russian Federation