Pulmonary and Extrapulmonary Impairments in Patients With Post COVID-19

July 22, 2023 updated by: Meral Boşnak Güçlü, Gazi University

Investigation of Oxygen Consumption Chronotropic Response and Physical Activity Level in Patients With Post COVID-19

Pulmonary involvement and fibrosis could be seen in patients after COVID-19. Especially diffusion capacity, pulmonary function, exercise capacity and muscle strength have decreased in patients with COVID-19. Some symptom complaints of patients might continue after the disease, also. It has been shown that COVID-19 causes pulmonary involvement. However, the number of studies revealing the extent of pulmonary and extrapulmonary exposure due to COVID 19 comparing to healthy individuals is very limited, and has not been adequately investigated yet.

Study Overview

Status

Recruiting

Conditions

Detailed Description

Patients who had diagnosed with COVID-19 and participants who do not have any diagnosed disease will be evaluated in this study. Twenty-five patients with post COVID-19 and 25 age- and sex-matched healthy controls will be included according to inclusion and exclusion criteria. All assessments will be completed in two days. Oxygen consumption, physical activity level, chronotropic response, pulmonary function, functional exercise capacity, respiratory and peripheral strength, inspiratory muscle endurance, functional dyspnea, fatigue perception and quality of life will be investigated in patients with COVID-19 and compared with age- and sex-matched healthy controls.

Primary outcome measurements will be oxygen consumption (cardiopulmonary exercise test), chronotropic response (results of cardiopulmonary exercise test) and physical activity level (multi sensor activity device). Secondary outcome will be pulmonary function (spirometer), functional exercise capacity (six minute walk test), respiratory muscle strength (mouth pressure device), peripheral muscle (hand-held dynamometer) strength, inspiratory muscle endurance (incremental threshold loading test), dyspnea (London Chest Daily Living Activity Scale), fatigue (Fatigue Severity Scale) and quality of life (Saint George Respiratory Questionnaire) and functional status (Post-COVID-19 Functional Status Scale).

Study Type

Observational

Enrollment (Estimated)

50

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

  • Turkey
      • Ankara, Turkey, 06560
        • Recruiting
        • Gazi University, Faculty of Health Sciences, Department of Physiotherapy and Rehabilitation, Cardiopulmonary Rehabilitation Clinic
        • Contact:
        • Contact:

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

18 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Sampling Method

Non-Probability Sample

Study Population

At least 25 patients with COVID will be included in patients group and 25 healthy individuals will be included in control group.

Description

Inclusion Criteria:

Patients;

  • aged between 18-75 years
  • diagnosed with COVID-19 before
  • patients whose COVID-19 Polymerase Chain Reaction test turned negative or be negative already
  • patients who are willing to participate in this study.

Healthy controls;

  • aged between 18-75 years
  • patients who are willing to participate in this study.

Exclusion Criteria:

Patients;

  • body mass index >35 kg/m2
  • cancer, renal or hepatic diseases
  • aortic stenosis, complex arrhythmia, aortic aneurysm
  • serious neurological, neuromuscular, orthopedic, other systemic diseases or. other diseases affecting physical functions
  • uncontrolled hypertension and/or diabetes mellitus, heart failure and cardiovascular disease
  • acute pulmonary exacerbation, acute upper or lower respiratory tract infection
  • cognitive impairment that causes difficulty in understanding and following exercise test instructions
  • bulla formation in the lung
  • participated in a planned exercise program in the last three months
  • contraindication for exercise testing and/or exercise training according to the American College of Sports Medicine

Healthy controls;

  • history of coronavirus disease
  • history of smoke exposure below 10 packs*years
  • have any diagnosed chronic or systemic diseases
  • have psychiatric disorder
  • body mass index >35 kg/m2
  • cognitive impairment that causes difficulty in understanding and following exercise test instructions
  • acute pulmonary exacerbation, acute upper or lower respiratory tract infection

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

  • Observational Models: Case-Control
  • Time Perspectives: Cross-Sectional

Cohorts and Interventions

Group / Cohort
Patients with Post COVID-19

That group consists from patients who had diagnosed with COVID-19 by doctors.

Oxygen consumption using cardiopulmonary exercise test, physical activity level using multi-sensor activity monitor, pulmonary function using spirometer, functional exercise capacity with six minute walk test, respiratory muscle strength using mouth pressure device, peripheral muscle strength with hand held dynamometer, inspiratory muscle endurance using incremental threshold loading test, dyspnea with 'Turkish version of London Chest Daily Living Activity Scale', fatigue with 'Turkish version of Fatigue Severity Scale' and quality of life with 'Turkish version of Saint George Respiratory Questionnaire' will be evaluated in patient with post COVID-19. Chronotropic response will be assessed according to results of maximal exercise test. Besides, functional statu of patients will be evaluated with Turkish version of 'Post COVID-19 Functional Status Scale'.
Healthy Group

That group consists from people who do not have any diagnosed disease.

Oxygen consumption using cardiopulmonary exercise test, physical activity level using multi-sensor activity monitor, pulmonary function using spirometer, functional exercise capacity with six minute walk test, respiratory muscle strength using mouth pressure device, peripheral muscle strength with hand held dynamometer, inspiratory muscle endurance using incremental threshold loading test, dyspnea with 'Turkish version of London Chest Daily Living Activity Scale', fatigue with 'Turkish version of Fatigue Severity Scale' and quality of life with 'Turkish version of Saint George Respiratory Questionnaire' will be evaluated in healthy controls.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Oxygen consumption
Time Frame: First day
Maximal exercise capacity will be assessed with symptom limited cardiopulmonary exercise test on a treadmill at a progressively increasing speed and grade. Oxygen consumption will be measured during the test.
First day
Chronotropic response
Time Frame: First day
The chronotropic response will be assessed using the results of the symptom limited cardiopulmonary exercise test. The chronotropic incompetence will be named according to the chronotropic index calculated from the test result.
First day
Physical activity level
Time Frame: Second day
Physical activity level will be evaluated with multi sensor activity device. Patients will be asked to wear the device for three consecutive days on weekdays.
Second day

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Functional exercise capacity
Time Frame: Second day
Six-minute walk test will be used to evaluate functional exercise capacity. The test will be done according to American Thoracic Society and European Respiratory Society criteria.
Second day
Respiratory muscle strength
Time Frame: Second day
Respiratory muscle strength will be assessed with mouth pressure device. Maximal inspiratory and expiratory pressure will be measured during the test.
Second day
Peripheral muscle strength
Time Frame: Second day
Quadriceps femoris and shoulder abduction muscle strength will be measured by using hand-held dynamometer.
Second day
Fatigue
Time Frame: First day
Fatigue will be assessed with Fatigue Severity Scale (Turkish version). This scale includes 9 items and each item scores from 1 (strong disagreement) to 7 (strong agreement) point. Fatigue Severity Scale total score is calculates by deriving an arithmetic mean. Cut-score of over 4 means significant fatigue and higher score indicates more severe fatigue.
First day
Pulmonary function
Time Frame: Second day
Dynamic lung volumes will be evaluated by using a spirometry according to the American Thoracic Society and European Respiratory Society criteria.
Second day
Inspiratory muscle endurance
Time Frame: Second day
Inspiratory muscle endurance will be measured incremental threshold loading test, in which patients started an initial load of 30% of maximal inspiratory pressure and test load will be increased with among 10% of maximal inspiratory pressure every two minutes.
Second day
Dyspnea
Time Frame: First day
Dyspnea perception during the daily living activities will be evaluated by using London Chest Daily Living Activity Scale (Turkish version). The highest total score could be obtained from the scale was 75, which indicates significant limitation in daily living activities due to dyspnea perception.
First day
Life Quality
Time Frame: First day
Quality of life will be assessed with Saint George Respiratory Questionnaire (SGRQ) (Turkish version). This questionnaire scores range from 0 to 100. The total highest score indicates poor quality of life.
First day
Modified Borg Scale
Time Frame: During the exercise tests
Modified Borg Scale will be used to assess dyspnea and fatigue perception of patients during cardiopulmonary exercise training and six-minute walk test. This scale is graded between 0 (nothing at all) and 10 (very very hard).
During the exercise tests
Functional status
Time Frame: First day
Functional status of patients after COVID-19 will be evaluated with Post COVID-19 Functional Status Scale (PCFS), which was developed specifically for COVID patients. Limitation and improvement in the functional status of patients after COVID could be assessed with this scale. Functional status are graded from 0 (no functional limitations) to 4 (severe functional limitations) in the scale.
First day

Collaborators and Investigators

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

Sponsor

Gazi University

Investigators

  • Study Chair: Ece BAYTOK, MsC., Gazi University
  • Principal Investigator: Başak KAVALCI KOL, MsC., Gazi University
  • Principal Investigator: Nilgün YILMAZ DEMİRCİ, Assoc.Prof., Gazi University
  • Study Director: Meral BOŞNAK GÜÇLÜ, Prof. Dr., Gazi University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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 15, 2022

Primary Completion (Estimated)

May 20, 2024

Study Completion (Estimated)

July 20, 2024

Study Registration Dates

First Submitted

May 17, 2022

First Submitted That Met QC Criteria

May 17, 2022

First Posted (Actual)

May 19, 2022

Study Record Updates

Last Update Posted (Actual)

July 25, 2023

Last Update Submitted That Met QC Criteria

July 22, 2023

Last Verified

July 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Gazi University90

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

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.

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