NCT04415827

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
170

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started May 2020

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 17, 2020

Completed
1 month until next milestone

Study Start

First participant enrolled

May 23, 2020

Completed
12 days until next milestone

First Posted

Study publicly available on registry

June 4, 2020

Completed
1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 22, 2021

Completed
11 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2022

Completed
Last Updated

June 4, 2020

Status Verified

May 1, 2020

Enrollment Period

1.6 years

First QC Date

April 17, 2020

Last Update Submit

June 3, 2020

Conditions

Keywords

sports medicinebicycle ergometrybronchopulmonary diseasesspiroergometry

Outcome Measures

Primary Outcomes (2)

  • 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.

  • 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 Outcomes (3)

  • 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.

  • 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.

  • 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.

Study Arms (8)

Athletes with community-acquired pneumonia

EXPERIMENTAL

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

Diagnostic Test: bicycle ergometry test with spiroergometry

Untrained people with community-acquired pneumonia

EXPERIMENTAL

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

Diagnostic Test: bicycle ergometry test with spiroergometry

Athletes with bronchitis

EXPERIMENTAL

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

Diagnostic Test: bicycle ergometry test with spiroergometry

Untrained people with bronchitis

EXPERIMENTAL

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

Diagnostic Test: bicycle ergometry test with spiroergometry

Athletes with chronic obstructive pulmonary disease

EXPERIMENTAL

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

Diagnostic Test: bicycle ergometry test with spiroergometry

Untrained people with chronic obstructive pulmonary disease

EXPERIMENTAL

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

Diagnostic Test: bicycle ergometry test with spiroergometry

Athletes with acute respiratory infections

EXPERIMENTAL

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

Diagnostic Test: bicycle ergometry test with spiroergometry

Untrained people with acute respiratory infections

EXPERIMENTAL

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

Diagnostic Test: bicycle ergometry test with spiroergometry

Interventions

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)

Athletes with acute respiratory infectionsAthletes with bronchitisAthletes with chronic obstructive pulmonary diseaseAthletes with community-acquired pneumoniaUntrained people with acute respiratory infectionsUntrained people with bronchitisUntrained people with chronic obstructive pulmonary diseaseUntrained people with community-acquired pneumonia

Eligibility Criteria

Age17 Years - 25 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • 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.

You may not qualify if:

  • refusal of the patient from further participation in the study;
  • non-compliance with treatment recommendations and regimen.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Sechenov University

Moscow, 119991, Russia

RECRUITING

MeSH Terms

Conditions

Community-Acquired PneumoniaBronchitisPulmonary Disease, Chronic Obstructive

Interventions

Exercise Test

Condition Hierarchy (Ancestors)

Community-Acquired InfectionsInfectionsPneumoniaRespiratory Tract InfectionsRespiratory Tract DiseasesBronchial DiseasesLung Diseases, ObstructiveLung DiseasesChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Heart Function TestsDiagnostic Techniques, CardiovascularDiagnostic Techniques and ProceduresDiagnosisRespiratory Function TestsDiagnostic Techniques, Respiratory SystemErgometryInvestigative Techniques

Study Officials

  • Viktoria S Moskvichyova

    I.M. Sechenov First Moscow State Medical University

    STUDY CHAIR

Central Study Contacts

Viktoria S Moskvichyova

CONTACT

Irina A Lazareva

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 17, 2020

First Posted

June 4, 2020

Study Start

May 23, 2020

Primary Completion

December 22, 2021

Study Completion

December 1, 2022

Last Updated

June 4, 2020

Record last verified: 2020-05

Data Sharing

IPD Sharing
Will not share

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

Locations