Energy Supply in Athletes and Untrained Persons With Bronchopulmonary Diseases

Sponsor

I.M. Sechenov First Moscow State Medical University (Other)

Overall Status

Recruiting

CT.gov ID

NCT04415827

Collaborator

(none)

170

Enrollment

Location

Arms

30.3

Anticipated Duration (Months)

5.6

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Community-acquired Pneumonia Bronchitis Chronic Obstructive Pulmonary Disease Acute Respiratory Infection	Diagnostic Test: bicycle ergometry test with spiroergometry	N/A

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

Study Type:

Interventional

Anticipated Enrollment :

170 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Prevention

Official Title:

Study of Energy Supply in Athletes and Untrained Persons With Diseases of the Bronchopulmonary System

Actual Study Start Date :

May 23, 2020

Anticipated Primary Completion Date :

Dec 22, 2021

Anticipated Study Completion Date :

Dec 1, 2022

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Athletes with community-acquired pneumonia man and women, athletes, age 17-25, patients with community-acquired pneumonia	Diagnostic Test: bicycle ergometry test with spiroergometry 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)
Experimental: Untrained people with community-acquired pneumonia man and women, untrained people, age 17-25, patients with community-acquired pneumonia	Diagnostic Test: bicycle ergometry test with spiroergometry 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)
Experimental: Athletes with bronchitis man and women, athletes, age 17-25, patients with bronchitis	Diagnostic Test: bicycle ergometry test with spiroergometry 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)
Experimental: Untrained people with bronchitis man and women, untrained people, age 17-25, patients with bronchitis	Diagnostic Test: bicycle ergometry test with spiroergometry 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)
Experimental: Athletes with chronic obstructive pulmonary disease man and women, athletes, age 17-25, patients with with chronic obstructive pulmonary disease	Diagnostic Test: bicycle ergometry test with spiroergometry 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)
Experimental: Untrained people with chronic obstructive pulmonary disease man and women, untrained people, age 17-25, patients with with chronic obstructive pulmonary disease	Diagnostic Test: bicycle ergometry test with spiroergometry 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)
Experimental: Athletes with acute respiratory infections man and women, athletes, age 17-25, patients with acute respiratory infections	Diagnostic Test: bicycle ergometry test with spiroergometry 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)
Experimental: Untrained people with acute respiratory infections man and women, untrained people, age 17-25, patients with acute respiratory infections	Diagnostic Test: bicycle ergometry test with spiroergometry 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)

Outcome Measures

Primary Outcome Measures

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

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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

17 Years to 25 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

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.