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Energy Supply in Athletes and Untrained Persons With Bronchopulmonary Diseases

Primary Purpose

Community-acquired Pneumonia, Bronchitis, Chronic Obstructive Pulmonary Disease

Status
Unknown status
Phase
Not Applicable
Locations
Russian Federation
Study Type
Interventional
Intervention
bicycle ergometry test with spiroergometry
Sponsored by
I.M. Sechenov First Moscow State Medical University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Community-acquired Pneumonia focused on measuring sports medicine, bicycle ergometry, bronchopulmonary diseases, spiroergometry

Eligibility Criteria

17 Years - 25 Years (Child, Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Sechenov UniversityRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm 6

Arm 7

Arm 8

Arm Type

Experimental

Experimental

Experimental

Experimental

Experimental

Experimental

Experimental

Experimental

Arm Label

Athletes with community-acquired pneumonia

Untrained people with community-acquired pneumonia

Athletes with bronchitis

Untrained people with bronchitis

Athletes with chronic obstructive pulmonary disease

Untrained people with chronic obstructive pulmonary disease

Athletes with acute respiratory infections

Untrained people with acute respiratory infections

Arm Description

man and women, athletes, age 17-25, patients with community-acquired pneumonia

man and women, untrained people, age 17-25, patients with community-acquired pneumonia

man and women, athletes, age 17-25, patients with bronchitis

man and women, untrained people, age 17-25, patients with bronchitis

man and women, athletes, age 17-25, patients with with chronic obstructive pulmonary disease

man and women, untrained people, age 17-25, patients with with chronic obstructive pulmonary disease

man and women, athletes, age 17-25, patients with acute respiratory infections

man and women, untrained people, age 17-25, patients with acute respiratory infections

Outcomes

Primary Outcome Measures

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.
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.

Secondary Outcome Measures

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.
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.
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.

Full Information

First Posted
April 17, 2020
Last Updated
June 3, 2020
Sponsor
I.M. Sechenov First Moscow State Medical University
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1. Study Identification

Unique Protocol Identification Number
NCT04415827
Brief Title
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

2. Study Status

Record Verification Date
May 2020
Overall Recruitment Status
Unknown status
Study Start Date
May 23, 2020 (Actual)
Primary Completion Date
December 22, 2021 (Anticipated)
Study Completion Date
December 1, 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
I.M. Sechenov First Moscow State Medical University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Community-acquired Pneumonia, Bronchitis, Chronic Obstructive Pulmonary Disease, Acute Respiratory Infection
Keywords
sports medicine, bicycle ergometry, bronchopulmonary diseases, spiroergometry

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
170 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Athletes with community-acquired pneumonia
Arm Type
Experimental
Arm Description
man and women, athletes, age 17-25, patients with community-acquired pneumonia
Arm Title
Untrained people with community-acquired pneumonia
Arm Type
Experimental
Arm Description
man and women, untrained people, age 17-25, patients with community-acquired pneumonia
Arm Title
Athletes with bronchitis
Arm Type
Experimental
Arm Description
man and women, athletes, age 17-25, patients with bronchitis
Arm Title
Untrained people with bronchitis
Arm Type
Experimental
Arm Description
man and women, untrained people, age 17-25, patients with bronchitis
Arm Title
Athletes with chronic obstructive pulmonary disease
Arm Type
Experimental
Arm Description
man and women, athletes, age 17-25, patients with with chronic obstructive pulmonary disease
Arm Title
Untrained people with chronic obstructive pulmonary disease
Arm Type
Experimental
Arm Description
man and women, untrained people, age 17-25, patients with with chronic obstructive pulmonary disease
Arm Title
Athletes with acute respiratory infections
Arm Type
Experimental
Arm Description
man and women, athletes, age 17-25, patients with acute respiratory infections
Arm Title
Untrained people with acute respiratory infections
Arm Type
Experimental
Arm Description
man and women, untrained people, age 17-25, patients with acute respiratory infections
Intervention Type
Diagnostic Test
Intervention Name(s)
bicycle ergometry test with spiroergometry
Intervention Description
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)
Primary Outcome Measure Information:
Title
Change of the respiratory system function at different periods of the bronchopulmonary disease
Description
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.
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.
Title
Change of the cardiovascular system function at different periods of the bronchopulmonary disease
Description
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.
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.
Secondary Outcome Measure Information:
Title
Change of electrical activity of the heart at different periods of the bronchopulmonary disease
Description
assesment a change of the electrical activity of the heart using stress test machine "Cardiovit", recording changes on an ECG (segment ST) during cycling.
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.
Title
Change of pulmonary ventilation at different periods of the bronchopulmonary disease
Description
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.
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.
Title
Change of pulmonary gas exchange at different periods of the bronchopulmonary disease
Description
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.
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.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
17 Years
Maximum Age & Unit of Time
25 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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. Exclusion Criteria: refusal of the patient from further participation in the study; non-compliance with treatment recommendations and regimen.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Viktoria S Moskvichyova
Phone
+79251290922
Email
moskvicheva_viktoria@mail.ru
First Name & Middle Initial & Last Name or Official Title & Degree
Irina A Lazareva
Phone
+79032316255
Email
ialazareva@mail.ru
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Viktoria S Moskvichyova
Organizational Affiliation
I.M. Sechenov First Moscow State Medical University
Official's Role
Study Chair
Facility Information:
Facility Name
Sechenov University
City
Moscow
ZIP/Postal Code
119991
Country
Russian Federation
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Viktoria S Moskvichyova
Phone
+79251290922
Email
moskvicheva_viktoria@mail.ru

12. IPD Sharing Statement

Plan to Share IPD
No
IPD Sharing Plan Description
prohibited by Local Ethics Committee of "I.M. Sechenov First Moscow State Medical University"

Learn more about this trial

Energy Supply in Athletes and Untrained Persons With Bronchopulmonary Diseases

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