Energy Supply in Athletes and Untrained Persons With Bronchopulmonary Diseases

Chronic Obstructive Pulmonary Disease Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04415827
• Other study ID #: 520122019
• Status: Recruiting
• Phase: N/A
• Start date: May 23, 2020
• Est. completion date: December 1, 2022

Study information

• Verified date: May 2020
• Source: I.M. Sechenov First Moscow State Medical University
• Contact: Viktoria S Moskvichyova
• Phone: +79251290922
• Email: moskvicheva_viktoria[@]mail.ru
• Is FDA regulated: No
• Study type: Interventional

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

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 170
• Est. completion date: December 1, 2022
• Est. primary completion date: December 22, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 17 Years to 25 Years

Eligibility

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.

Related Conditions & MeSH terms

• Acute Respiratory Infection
• Bronchitis
• Chronic Obstructive Pulmonary Disease
• Community-acquired Pneumonia
• Lung Diseases, Obstructive
• Pneumonia
• Pulmonary Disease, Chronic Obstructive
• Respiratory Tract Infections

Intervention

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)

Locations

Country	Name	City	State
Russian Federation	Sechenov University	Moscow

Sponsors (1)

Lead Sponsor	Collaborator
I.M. Sechenov First Moscow State Medical University

Country where clinical trial is conducted

Russian Federation, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	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.
Primary	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.	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	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.	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	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.	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	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.	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.