Energy Supply in Athletes and Untrained Persons With Bronchopulmonary Diseases

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.

Study Overview

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 Type

Interventional

Enrollment (Anticipated)

170

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

17 years to 25 years (Child, Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Athletes with community-acquired pneumonia
man and women, athletes, age 17-25, patients with community-acquired pneumonia

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

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

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

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

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

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

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

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)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
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
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.
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
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.
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.
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.
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.
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.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Study Chair: Viktoria S Moskvichyova, I.M. Sechenov First Moscow State Medical University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 23, 2020

Primary Completion (Anticipated)

December 22, 2021

Study Completion (Anticipated)

December 1, 2022

Study Registration Dates

First Submitted

April 17, 2020

First Submitted That Met QC Criteria

June 3, 2020

First Posted (Actual)

June 4, 2020

Study Record Updates

Last Update Posted (Actual)

June 4, 2020

Last Update Submitted That Met QC Criteria

June 3, 2020

Last Verified

May 1, 2020

More Information

Terms related to this study

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

IPD Plan Description

prohibited by Local Ethics Committee of "I.M. Sechenov First Moscow State Medical University"

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Chronic Obstructive Pulmonary Disease

Clinical Trials on bicycle ergometry test with spiroergometry

3
Subscribe