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Pulmonary and Extrapulmonary Impairments in Patients With Post COVID-19

Sponsor
Gazi University (Other)
Overall Status
Recruiting
CT.gov ID
NCT05381727
Collaborator
(none)
50
Enrollment
1
Location
26.2
Anticipated Duration (Months)
1.9
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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.

Condition or Disease Intervention/Treatment Phase

    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 Design

    Study Type:
    Observational
    Anticipated Enrollment :
    50 participants
    Observational Model:
    Case-Control
    Time Perspective:
    Cross-Sectional
    Official Title:
    Investigation of Oxygen Consumption Chronotropic Response and Physical Activity Level in Patients With Post COVID-19
    Actual Study Start Date :
    May 15, 2022
    Anticipated Primary Completion Date :
    May 20, 2024
    Anticipated Study Completion Date :
    Jul 20, 2024

    Arms and Interventions

    Arm Intervention/Treatment
    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.

    Outcome Measures

    Primary Outcome Measures

    1. Oxygen consumption [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.

    2. Chronotropic response [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.

    3. Physical activity level [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.

    Secondary Outcome Measures

    1. Pulmonary function [Second day]

      Dynamic lung volumes will be evaluated by using a spirometry according to the American Thoracic Society and European Respiratory Society criteria.

    2. Functional exercise capacity [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.

    3. Respiratory muscle strength [Second day]

      Respiratory muscle strength will be assessed with mouth pressure device. Maximal inspiratory and expiratory pressure will be measured during the test.

    4. Peripheral muscle strength [Second day]

      Quadriceps femoris and shoulder abduction muscle strength will be measured by using hand-held dynamometer.

    5. Inspiratory muscle endurance [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.

    6. Dyspnea [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.

    7. Fatigue [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.

    8. Life Quality [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.

    9. Modified Borg Scale [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).

    10. Functional status [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.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 75 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    Yes
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Gazi University, Faculty of Health Sciences, Department of Physiotherapy and Rehabilitation, Cardiopulmonary Rehabilitation Clinic Ankara Turkey 06560

    Sponsors and Collaborators

    • 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

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    Responsible Party:
    Meral Boşnak Güçlü, Study director, PT, PhD, Prof.Dr. Faculty of Health Sciences, Department of Physiotherapy and Rehabilitation, Head of Cardiopulmonary Rehabilitation Clinic, Gazi University
    ClinicalTrials.gov Identifier:
    NCT05381727
    Other Study ID Numbers:
    • Gazi University90
    First Posted:
    May 19, 2022
    Last Update Posted:
    May 19, 2022
    Last Verified:
    May 1, 2022
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by Meral Boşnak Güçlü, Study director, PT, PhD, Prof.Dr. Faculty of Health Sciences, Department of Physiotherapy and Rehabilitation, Head of Cardiopulmonary Rehabilitation Clinic, Gazi University
    COVID-19
    Oxygen consumption
    Chronotropic response
    Physical activity
    Additional relevant MeSH terms:
    COVID-19

    Study Results

    No Results Posted as of May 19, 2022