COVID-19 PneumoniaNCT06272266
The Aerobic Exercise Capacity and Muscle Strenght in Individuals With COVID-19
A study testing Kardiopulmonary exercise test (Quark KPET C12x/T12x device connected to the Omnia version 1.6.8 COSMED system), Peripheral muscle strength measurement (microFET3 (Hoggan Health Industries, Fabrication Enterprises, lnc) and JAMAR hydraulic hand dynamometer (Sammons Preston, Rolyon, Bolingbrook). and Standard exercise tolerance test (a bicycle ergometer and recorded through the ergoline rehabilitation system 2 Version 1.08 SPI.) in people with COVID-19 Pneumonia and COVID-19, run by Selda Sarıkaya at 1 site in Turkey (Türkiye).
Trial summary
The subject of the project is the impact of COVID-19 on the exercise capacity of patients. The long-term sequelae of COVID-19 infection are still unknown. It is not yet clear whether pulmonary sequelae, which may be a consequence of the disease, are associated with a measurable functional deficit. Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- COVID-19 Pneumonia, COVID-19
- What is being tested?
- Kardiopulmonary exercise test (Quark KPET C12x/T12x device connected to the Omnia version 1.6.8 COSMED system), Peripheral muscle strength measurement (microFET3 (Hoggan Health Industries, Fabrication Enterprises, lnc) and JAMAR hydraulic hand dynamometer (Sammons Preston, Rolyon, Bolingbrook). and Standard exercise tolerance test (a bicycle ergometer and recorded through the ergoline rehabilitation system 2 Version 1.08 SPI.)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 41 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 20 Apr 2022to 15 Feb 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Being a healthy volunteer between the ages of 18-55
- be an independent ambulance
Who cannot join
- -Not being willing to participate in the study
- Be over 55 years old
- Previous symptomatic or asymptomatic coronavirus infection
- Severe audio-visual loss Unstable cardiovascular, neurological or psychiatric disease
- Pregnancy status
- Active asthma and exacerbation of COPD
- Malignancy Neurodegenerative disease with muscle destruction
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Zonguldak Bülent Ecevit University
Zonguldak, 67100
About this study
Official title: Determination of Exercise Capacity and Muscle Strenght in Individuals With COVID-19, the Effect of Aerobic Exercise Training.
The subject of the project is the impact of COVID-19 on the exercise capacity of patients. The long-term sequelae of COVID-19 infection are still unknown. It is not yet clear whether pulmonary sequelae, which may be a consequence of the disease, are associated with a measurable functional deficit. In this project, the aerobic capacity of healthy people will be compared with individuals who have experienced Covid-19, and the amount of increase in aerobic capacity will be determined at the end of 15 sessions by applying a rehabilitation program including bicycle ergometry to individuals who have experienced Covid-19 Detailed description : In December 2020, in the pneumonia epidemic in which the city of Wuhan, China is the center, pneumonia developed due to the newly defined SARS-CoV-2 factor was defined as Coronavirus disease 2019 (COVID-19). It has been observed that clinical findings of SARS-CoV-2 infection in patients hospitalized in Wuhan range from mild manifestations such as asymptomatic disease and mild upper respiratory tract infection to severe viral pneumonia accompanied by respiratory failure and may result in death.The long-term sequelae of COVID19 are still unknown. Pulmonary sequelae that impair physical fitness have been predominantly defined for hospitalized patients with COVID-19. Although lung lesions have been identified as asymptomatically in infected individuals, it is not yet clear whether these observations are related to a measurable functional deficit in physical fitness. They measured the change in the predicted maximum aerobic capacity (VO2 max) of non-infected,asymptomatically infected, and recovering COVID-19 individuals with a well-established and validated physical fitness test before and after the COVID-19 outbreak among young Swiss adults.They demonstrated decreased aerobic capacity in young adults 1 to 2 months after symptomatic COVID-19 without physical strength being affected. In their study, 19% of young adults who recovered after COVID-19 had a VO2 max decrease of more than 10% compared to baseline before infection. It has been identified that decreased VO2 max value is the hallmark of interstitial lung disease. SARS-CoV-2 infection causes lung damage even in asymptomatic cases.
A total of 64 people, including 32 people in 2 groups between the ages of 18-55, who have or have not had corona virus infection, who applied to Bülent Ecevit University Faculty of Medicine Physical Therapy and Rehabilitation or Infectious Diseases outpatient clinics for different reasons, will be included in our project. The research start date is February 2021 and the end date is February 2023. At the beginning of the study, demographic information of the individuals such as gender, age,height, weight, occupation, education, body mass index, physical activity level (international physical activity index-IPAQ), the most used hand (dominant hand) in daily life activities will be recorded. In the control group, resting heart rate, blood pressure, saturation measurement, ECG will be performed before exercise. In addition, in order to evaluate their muscle strength, microFET3 manual muscle measurement device will be used to measure the triceps muscle strength in the upper extremity they actively use, and the quadriceps muscle strength of the same side will be measured, and their grip strength will be measured with the JAMAR hydraulic hand dynamometer. Using the international physical activity index(IPAQ), activity status in daily life will be assessed. The exercise capacity of all individuals will be measured with the aid of the COSMED Quark CPET device using the bicycle ergometry test recommended by the American Society of Cardiovascular and Pulmonary Rehabilitation. In this test, submaximal exercise test will be performed by providing 25 W increase in 2 minutes periods after the warm-up period at 0 load (W) for 2 minutes. In addition, the borg scale obtained at the end of the test, metabolic equivalent of task (MET) and maximum work (W), test duration, maximum heart rate parameters will also be recorded in order to evaluate the exercise capacity.
Individuals who have been confirmed by the previous SARS-COV 2 real-time reverse transcriptase polymerase chain reaction (RT-PCR) test to have coronovirus infection after the test will be included in a treatment program of 15 sessions, at least 3 sessions per week, with bicycle ergometry. After 15 sessions, exercise capacity will be re-evaluated using the cycling test, the aforementioned triceps and grip muscle strengths, V02 max, maximum conjugate (MET), maximum work (w), borg scale, maximum heart rate, test time parameters will be saved again after treatment.
Read the detailed description
The cardiopulmonary exercise test was also performed on 14 individuals from the control group and 15 individuals in the patient group, and by this test, the respiratory exchange ratio (RER), anaerobic threshold (AT), maximum oxygen capacity (VO 2peak ), maximum ventilatory capacity at anaerobic threshold (VO 2AT ), carbon dioxide ventilatory equivalent (VE/CO 2 ), heart rate recovery (HRR) and heart rate recovery at 1 min (HRR1) parameters were evaluated. The test was repeated after 15 sessions of aerobic exercise training for the individuals in the COVID-19 group who participated in the cardiopulmonary exercise test, and the patients were evaluated using the same parameters.
- Conditions
- COVID-19 Pneumonia, COVID-19
- Being tested
- Kardiopulmonary exercise test (Quark KPET C12x/T12x device connected to the Omnia version 1.6.8 COSMED system), Peripheral muscle strength measurement (microFET3 (Hoggan Health Industries, Fabrication Enterprises, lnc) and JAMAR hydraulic hand dynamometer (Sammons Preston, Rolyon, Bolingbrook)., Standard exercise tolerance test (a bicycle ergometer and recorded through the ergoline rehabilitation system 2 Version 1.08 SPI.), Aerobic exercise training (a bicycle ergometer and recorded through the ergoline rehabilitation system 2 Version 1.08 SPI.)
- Keywords
- coronavirus infection, aerobic capacity, cardiopulmonary rehabilitation
- Medical subject headings
- COVID-19, Coronavirus Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Kardiopulmonary exercise test (Quark KPET C12x/T12x device connected to the Omnia version 1.6.8 COSMED system)Device
For the cardiopulmonary exercise test, a Quark KPET C12x/T12x device connected to the Omnia version 1.6.8 COSMED system, supported by analyzers that measure oxygen uptake and carbon dioxide output, and a bicycle ergometer connected to the ergoline rehab system 2 Version 1.08 SPI system were used. At the end of the test, the individual's RER , VAT, VO2peak, VO2AT, VE/CO2, HRR, HRR1 values were recorded. These values were estimated by the device based on the "wasserman extended" protocol on the Quark KPET C12x/T12x device connected to the Omnia version 1.6.8 COSMED system.The test was repeated after 15 sessions of aerobic exercise training in the Covid-19 group.This intervention was applied to 14 people in the COVID-19 group and 15 people in the control group. It was repeated at the end of 15 sessions of aerobic exercise training in the COVID-19 group.
Peripheral muscle strength measurement (microFET3 (Hoggan Health Industries, Fabrication Enterprises, lnc) and JAMAR hydraulic hand dynamometer (Sammons Preston, Rolyon, Bolingbrook).Device
Quadriceps and triceps muscle strength was measured in kilograms using the microFET3 (Hoggan Health Industries, Fabrication Enterprises, lnc) manual muscle strength measurement device in the lower and upper extremity. Hand grip strength was evaluated in the dominant upper extremity using a JAMAR hydraulic hand dynamometer (Sammons Preston, Rolyon, Bolingbrook)This intervention was repeated for individuals in both groups at the beginning and at the end of the 15-session aerobic exercise training planned for the COVID-19 group.
Standard exercise tolerance test (a bicycle ergometer and recorded through the ergoline rehabilitation system 2 Version 1.08 SPI.)Device
At the beginning of this test, resting pulse and blood pressure were measured and recorded. The test was performed following a bicycle ergometer protocol recommended by the American Cardiovascular and Pulmonary Rehabilitation Society. After a 2-minute warm-up period at 0 load (W), a submaximal exercise test was performed by increasing the load by 25 W in 2-minute periods. At the end of the test, exercise intensity was evaluated with the perceived difficulty level (borg scale), test duration, maximum heart rate, maximum work (W). , metabolic equivalent (MET) values were recorded. VO2peak and VO2peakpredictive levels were calculated. This test was repeated for individuals in both groups at the beginning and at the end of the 15-session aerobic exercise training planned for the COVID-19 group.
Aerobic exercise training (a bicycle ergometer and recorded through the ergoline rehabilitation system 2 Version 1.08 SPI.)Device
Aerobic exercise training was planned for the COVID-19 group with the help of a bicycle ergometer and recorded through the ergoline rehabilitation system 2 Version 1.08 SPI. Aerobic exercise training was applied for a total of 15 sessions, at least 3 days a week, under the supervision of a physician.
| Study group | Role | What they receive |
|---|---|---|
| COVID-19 group | Active comparator | This group included 32 people aged 18-55 who had previously had COVID-19. Individuals' physical activity levels were measured with the IPAQ short form. Peripheral muscle strength (quadriceps muscle strength, triceps strength, hand grip strength) was measured. The exercise capacities of the individuals were evaluated with a standard exercise tolerance test using a bicycle ergometer. At the end of the test, Borg Scale, test duration, maximum heart rate, maximum work (W) and MET values were recorded. VO2peak levels and VO2peak prediction values were calculated. CPET was applied to 14 people in this group. At the end of the test, the individual's Respiratory Exchange Rate, Anaerobic Threshold, VO2peak, VO2AT (Maximum Oxygen Capacity at Respiratory Anaerobic Threshold), Carbon Dioxide Ventilation Equivalent, heart rate recovery, heart rate recovery in the 1st minute were measured. Aerobic exercise training was given to 14 people in this group. measurements were repeated. Receives: Device: Kardiopulmonary exercise test (Quark KPET C12x/T12x device connected to the Omnia version 1.6.8 COSMED system); Device: Peripheral muscle strength measurement (microFET3 (Hoggan Health Industries, Fabrication Enterprises, lnc) and JAMAR hydraulic hand dynamometer (Sammons Preston, Rolyon, Bolingbrook).; Device: Standard exercise tolerance test (a bicycle ergometer and recorded through the ergoline rehabilitation system 2 Version 1.08 SPI.); Device: Aerobic exercise training (a bicycle ergometer and recorded through the ergoline rehabilitation system 2 Version 1.08 SPI.) |
| control group | Active comparator | This group included 32 people aged 18-55 who had not previously had COVID-19. The physical activity levels of the individuals were measured with the IPAQ short form. Peripheral muscle strength (quadriceps muscle strength, triceps strength, hand grip strength) was measured. The exercise capacities of the individuals were evaluated with a standard exercise tolerance test using a bicycle ergometer. At the end of the test, Borg Scale, test duration, maximum heart rate, maximum work (W) and MET values were recorded. VO2peak levels and VO2peak prediction values were calculated. CPET was applied to 15 people in this group. At the end of the test, the individual's Respiratory Change Rate, Anaerobic Threshold, VO2peak, VO2AT (Maximum Oxygen Capacity at Respiratory Anaerobic Threshold), Carbon Dioxide Ventilation Equivalent, heart rate recovery, Heart rate recovery at 1 minute was measured. Receives: Device: Kardiopulmonary exercise test (Quark KPET C12x/T12x device connected to the Omnia version 1.6.8 COSMED system); Device: Peripheral muscle strength measurement (microFET3 (Hoggan Health Industries, Fabrication Enterprises, lnc) and JAMAR hydraulic hand dynamometer (Sammons Preston, Rolyon, Bolingbrook).; Device: Standard exercise tolerance test (a bicycle ergometer and recorded through the ergoline rehabilitation system 2 Version 1.08 SPI.) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Assessment of Triceps muscle strength by using the Micro FET3 muscle strength device
Triceps and quadriceps muscle strength; It was measured in kilograms using the microFET3 (Hoggan Health Industries, Fabrication Enterprises, lnc) manual muscle strength measurement device in the dominant upper and lower extremities.
Measured: 3-5 weeks
Assessment of Maximum work (watts) ın the standard exercise tolerance test using a bicycle ergometer and recording it via ergoline rehab system 2 Version 1.08 SPI.
In the standard exercise tolerance test, individuals were subjected to an exercise test by using a bicycle ergometer and recording it via ergoline rehab system 2 Version 1.08 SPI. The maximum work (watts) that the individuals could reach in the standard exercise tolerance test was recorded.The measurement was repeated after 15 sessions of aerobic exercise training in the Covid-19 group.
Measured: 3-5 weeks
Assessment of Metabolic Equivalent (MET) in the standard exercise tolerance test using a bicycle ergometer and recording it via ergoline rehab system 2 Version 1.08 SPI.
In the standard exercise tolerance test, individuals were subjected to an exercise test by using a bicycle ergometer and recording it via ergoline rehab system 2 Version 1.08 SPI. The maximum work (watts) that the individuals could reach in the standard exercise tolerance test was recorded.The measurement was repeated after 15 sessions of aerobic exercise training in the Covid-19 group.
Measured: 3-5 weeks
Assessment of VO2peak (ml/kg/min) in the exercise tolerance test using a bicycle ergometer and recording it via ergoline rehab system 2 Version 1.08 SPI.
In the standard exercise tolerance test, individuals were subjected to exercise testing using a bicycle ergometer and recorded through the ergoline rehabilitation system 2 Version 1.08 SPI. VO2peak was calculated based on the maximum work (watts) that individuals could achieve in the standard exercise tolerance test.The measurement was repeated after 15 sessions of aerobic exercise training in the Covid-19 group
Measured: 3-5 weeks
Assessment of VO2peakpredictive (%) in the standard exercise tolerance test using a bicycle ergometer and recording it via ergoline rehab system 2 Version 1.08 SPI.
In the standard exercise tolerance test, individuals were subjected to exercise testing using a bicycle ergometer and recorded through the ergoline rehabilitation system 2 Version 1.08 SPI. VO2peakpredictive was calculated based on the maximum work (watts) that individuals could achieve in the standard exercise tolerance test.The measurement was repeated after 15 sessions of aerobic exercise training in the Covid-19 group.
Measured: 3-5 weeks
Assessment of Hand grip strength (kg) by using a JAMAR hydraulic hand dynamometer (Sammons Preston, Rolyon, Bolingbrook).
Hand grip strength was evaluated in the dominant upper extremity using a JAMAR hydraulic hand dynamometer (Sammons Preston, Rolyon, Bolingbrook). Two consecutive tests were performed on individuals in a sitting position with shoulders in adduction and neutral rotation, elbows in 90 degrees of flexion, forearm and wrist in 0-30 degrees of extension and 0-15 degrees of ulnar deviation, and the highest grip strength was recorded and evaluated in kilograms.The measurement was repeated after 15 sessions of aerobic exercise training in the Covid-19 group.
Measured: 3-5 weeks
Assessment of Exchange Ratio(RER ) by using cardiopulmonary exercise test, a Quark KPET C12x/T12x device connected to the Omnia version 1.6.8 COSMED system,
For the cardiopulmonary exercise test, a Quark KPET C12x/T12x device connected to the Omnia version 1.6.8 COSMED system, supported by analyzers that measure oxygen uptake and carbon dioxide output, and a bicycle ergometer connected to the ergoline rehab system 2 Version 1.08 SPI system were used. At the end of the test, the individual's RER , VAT, VO2peak, VO2AT, VE/CO2, HRR, HRR1 values were recorded. These values were estimated by the device based on the "wasserman extended" protocol on the Quark KPET C12x/T12x device connected to the Omnia version 1.6.8 COSMED system.The test was repeated after 15 sessions of aerobic exercise training in the Covid-19 group
Measured: 3-5 weeks
Assessment of Anaerobik Treshold (VAT) by using cardiopulmonary exercise test with a Quark KPET C12x/T12x device connected to the Omnia version 1.6.8 COSMED system,
For the cardiopulmonary exercise test, a Quark KPET C12x/T12x device connected to the Omnia version 1.6.8 COSMED system, supported by analyzers that measure oxygen uptake and carbon dioxide output, and a bicycle ergometer connected to the ergoline rehab system 2 Version 1.08 SPI system were used. At the end of the test, the individual's RER , VAT, VO2peak, VO2AT, VE/CO2, HRR, HRR1 values were recorded. These values were estimated by the device based on the "wasserman extended" protocol on the Quark KPET C12x/T12x device connected to the Omnia version 1.6.8 COSMED system.The test was repeated after 15 sessions of aerobic exercise training in the Covid-19 group
Measured: 3-5 weeks
Assessment of Maximum Oxygen Capacity (VO2peak) by using cardiopulmonary exercise test with a Quark KPET C12x/T12x device connected to the Omnia version 1.6.8 COSMED system,
For the cardiopulmonary exercise test, a Quark KPET C12x/T12x device connected to the Omnia version 1.6.8 COSMED system, supported by analyzers that measure oxygen uptake and carbon dioxide output, and a bicycle ergometer connected to the ergoline rehab system 2 Version 1.08 SPI system were used At the end of the test, the individual's RER , VAT, VO2peak, VO2AT, VE/CO2, HRR, HRR1 values were recorded. These values were estimated by the device based on the "wasserman extended" protocol on the Quark KPET C12x/T12x device connected to the Omnia version 1.6.8 COSMED system.The test was repeated after 15 sessions of aerobic exercise training in the Covid-19 group
Measured: 3-5 weeks
Assessment of Maximum Oxygen Capacity at Ventilatory Anaerobic Threshold (VO2AT) by using cardiopulmonary exercise test with a Quark KPET C12x/T12x device connected to the Omnia version 1.6.8 COSMED system,
For the cardiopulmonary exercise test, a Quark KPET C12x/T12x device connected to the Omnia version 1.6.8 COSMED system, supported by analyzers that measure oxygen uptake and carbon dioxide output, and a bicycle ergometer connected to the ergoline rehab system 2 Version 1.08 SPI system were used. At the end of the test, the individual's RER , VAT, VO2peak, VO2AT, VE/CO2, HRR, HRR1 values were recorded. These values were estimated by the device based on the "wasserman extended" protocol on the Quark KPET
Measured: 3-5 weeks
Assessment of Carbon Dioxide Ventilatory Equivalent (VE/CO2) by using cardiopulmonary exercise test with a Quark KPET C12x/T12x device connected to the Omnia version 1.6.8 COSMED system,
For the cardiopulmonary exercise test, a Quark KPET C12x/T12x device connected to the Omnia version 1.6.8 COSMED system, supported by analyzers that measure oxygen uptake and carbon dioxide output, and a bicycle ergometer connected to the ergoline rehab system 2 Version 1.08 SPI system were used. At the end of the test, the individual's RER , VAT, VO2peak, VO2AT, VE/CO2, HRR, HRR1 values were recorded. These values were estimated by the device based on the "wasserman extended" protocol on the Quark KPET
Measured: 3-5 weeks
Assessment of Heart Rate Recovery (HRR) by using cardiopulmonary exercise test with a Quark KPET C12x/T12x device connected to the Omnia version 1.6.8 COSMED system,
For the cardiopulmonary exercise test, a Quark KPET C12x/T12x device connected to the Omnia version 1.6.8 COSMED system, supported by analyzers that measure oxygen uptake and carbon dioxide output, and a bicycle ergometer connected to the ergoline rehab system 2 Version 1.08 SPI system were used. At the end of the test, the individual's RER , VAT, VO2peak, VO2AT, VE/CO2, HRR, HRR1 values were recorded. These values were estimated by the device based on the "wasserman extended" protocol on the Quark KPET
Measured: 3-5 weeks
Assessment of Heart Rate Recovery at first minute (HRR1) by using cardiopulmonary exercise test with a Quark KPET C12x/T12x device connected to the Omnia version 1.6.8 COSMED system,
For the cardiopulmonary exercise test, a Quark KPET C12x/T12x device connected to the Omnia version 1.6.8 COSMED system, supported by analyzers that measure oxygen uptake and carbon dioxide output, and a bicycle ergometer connected to the ergoline rehab system 2 Version 1.08 SPI system were used. At the end of the test, the individual's RER , VAT, VO2peak, VO2AT, VE/CO2, HRR, HRR1 values were recorded. These values were estimated by the device based on the "wasserman extended" protocol on the Quark KPET
Measured: 3-5 weeks
Assessment of quadriceps muscle strength by using the Micro FET3 muscle strength device
Triceps and quadriceps muscle strength; It was measured in kilograms using the microFET3 (Hoggan Health Industries, Fabrication Enterprises, lnc) manual muscle strength measurement device in the dominant upper and lower extremities.
Measured: 3-5 weeks
Secondary outcomes (6)
Assessment of Physical activity by using the International Physical Activity Questionnaire (IPAQ)
International Physical Activity Questionnaire (IPAQ) is a scale based on self-report, developed as a result of research conducted in 12 different countries with the support of WHO (Craig et al., 2003). The short form of the scale consists of 7 items. Through the scale, the time spent by the individual for sitting, walking, and moderate and high intensity physical activities is tried to be determined. The time and day values obtained from the scale are multiplied by the MET value determined for each item and added to the total physical activity time. MET values are calculated as sitting: 1.5 MET, walking: 3.3 MET, moderate physical activity: 4.0 MET, vigorous physical activity: 8.0 MET. With the physical activity value obtained after the calculation, the person is classified according to low, medium or high physical activity level.
Measured: 3-5 weeks
Assessment of Test Duration (min) in the standard exercise tolerance test using a bicycle ergometer and recording it via ergoline rehab system 2 Version 1.08 SPI.
In the standard exercise tolerance test, individuals were subjected to exercise testing using a bicycle ergometer and recorded via the ergoline rehabilitation system 2 Version 1.08 SPI. In the standard exercise tolerance test, the test time completed by individuals was measured and recorded.The measurement was repeated after 15 sessions of aerobic exercise training in the Covid-19 group.
Measured: 3-5 weeks
Assessment of Perceived Difficulty by using the Borg Scale
The Borg scale is a simple numerical list. Participants are asked to rate their exertion on the scale during the exercise test, taking into consideration feelings of physical stress and fatigue, disregarding any factor such as leg pain or breathlessness but focusing on the whole feeling of exertion. This is the original 6 - 20 scale for ratings of perceived exertion.The measurement was repeated after 15 sessions of aerobic exercise training in the Covid-19 group.
Measured: 3-5 weeks
Assessment of Maximum heart rate (beats/min) in the standard exercise tolerance test using a bicycle ergometer and recording it via ergoline rehab system 2 Version 1.08 SPI.
In the standard exercise tolerance test, individuals were subjected to an exercise test by using a bicycle ergometer and recording it via ergoline rehab system 2 Version 1.08 SPI. The maximum heart rate that the individuals could reach in the standard exercise tolerance test was recorded.The measurement was repeated after 15 sessions of aerobic exercise training in the Covid-19 group.
Measured: 3-5 weeks
Assessment of Systolic and diastolic blood pressure (mmHg) by using a blood pressure monitor
Individuals' resting systolic and diastolic blood pressure (mmHg) were measured before and after the exercise test.The measurement was repeated after 15 sessions of aerobic exercise training in the Covid-19 group.
Measured: 3-5 weeks
Assessment of resting heart rate (beats/min) by using a a pulse oximeter
individuals resting heart rate was measured with a pulse oximeter before and after the exercise test.The measurement was repeated after 15 sessions of aerobic exercise training in the Covid-19 group.
Measured: 3-5 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Feb 2024
- Study start20 Apr 2022
- Primary completion30 May 2022
- Study completion15 Feb 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for COVID-19 PneumoniaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 41 participants (actual)
Sponsor and investigators
- Lead sponsor
- Selda Sarıkaya
- Sponsor type
- University, hospital or other
- Collaborators
- Zonguldak Bulent Ecevit University
- Responsible party
- Sponsor-investigator, Selda Sarıkaya, Bulent Ecevit University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06272266
- Sponsor's protocol ID
- 2021/03-26
- Status last verified
- Feb 2024
- First submitted
- 6 Apr 2022
- Last updated
- 22 Feb 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Determination of Exercise Capacity and Muscle Strenght in Individuals With COVID-19, the Effect of Aerobic Exercise Training.
- ClinicalTrials.gov ID
- NCT06272266
- Acronym / sponsor ID
- 2021/03-26
- Conditions
- COVID-19 Pneumonia, COVID-19
- Keywords
- coronavirus infection, aerobic capacity, cardiopulmonary rehabilitation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 41 participants (actual)
- Lead sponsor
- Selda SarıkayaUniversity, hospital or other
- Collaborators
- Zonguldak Bulent Ecevit University
- Study start
- 20 Apr 2022 (actual)
- Primary completion
- 30 May 2022 (actual)
- Study completion
- 15 Feb 2023 (actual)
- First posted
- 22 Feb 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The subject of the project is the impact of COVID-19 on the exercise capacity of patients. The long-term sequelae of COVID-19 infection are still unknown. It is not yet clear whether pulmonary sequelae, which may be a consequence of the disease, are associated with a measurable functional deficit. In this project, the aerobic capacity of healthy people will be compared with individuals who have experienced Covid-19, and the amount of increase in aerobic capacity will be determined at the end of 15 sessions by applying a rehabilitation program including bicycle ergometry to individuals who have experienced Covid-19 Detailed description : In December 2020, in the pneumonia epidemic in which the city of Wuhan, China is the center, pneumonia developed due to the newly defined SARS-CoV-2 factor was defined as Coronavirus disease 2019 (COVID-19). It has been observed that clinical findings of SARS-CoV-2 infection in patients hospitalized in Wuhan range from mild manifestations such as asymptomatic disease and mild upper respiratory tract infection to severe viral pneumonia accompanied by respiratory failure and may result in death.The long-term sequelae of COVID19 are still unknown. Pulmonary sequelae that impair physical fitness have been predominantly defined for hospitalized patients with COVID-19. Although lung lesions have been identified as asymptomatically in infected individuals, it is not yet clear whether these observations are related to a measurable functional deficit in physical fitness. They measured the change in the predicted maximum aerobic capacity (VO2 max) of non-infected,asymptomatically infected, and recovering COVID-19 individuals with a well-established and validated physical fitness test before and after the COVID-19 outbreak among young Swiss adults.They demonstrated decreased aerobic capacity in young adults 1 to 2 months after symptomatic COVID-19 without physical strength being affected. In their study, 19% of young adults who recovered after COVID-19 had a VO2 max decrease of more than 10% compared to baseline before infection. It has been identified that decreased VO2 max value is the hallmark of interstitial lung disease. SARS-CoV-2 infection causes lung damage even in asymptomatic cases.
A total of 64 people, including 32 people in 2 groups between the ages of 18-55, who have or have not had corona virus infection, who applied to Bülent Ecevit University Faculty of Medicine Physical Therapy and Rehabilitation or Infectious Diseases outpatient clinics for different reasons, will be included in our project. The research start date is February 2021 and the end date is February 2023. At the beginning of the study, demographic information of the individuals such as gender, age,height, weight, occupation, education, body mass index, physical activity level (international physical activity index-IPAQ), the most used hand (dominant hand) in daily life activities will be recorded. In the control group, resting heart rate, blood pressure, saturation measurement, ECG will be performed before exercise. In addition, in order to evaluate their muscle strength, microFET3 manual muscle measurement device will be used to measure the triceps muscle strength in the upper extremity they actively use, and the quadriceps muscle strength of the same side will be measured, and their grip strength will be measured with the JAMAR hydraulic hand dynamometer. Using the international physical activity index(IPAQ), activity status in daily life will be assessed. The exercise capacity of all individuals will be measured with the aid of the COSMED Quark CPET device using the bicycle ergometry test recommended by the American Society of Cardiovascular and Pulmonary Rehabilitation. In this test, submaximal exercise test will be performed by providing 25 W increase in 2 minutes periods after the warm-up period at 0 load (W) for 2 minutes. In addition, the borg scale obtained at the end of the test, metabolic equivalent of task (MET) and maximum work (W), test duration, maximum heart rate parameters will also be recorded in order to evaluate the exercise capacity.
Individuals who have been confirmed by the previous SARS-COV 2 real-time reverse transcriptase polymerase chain reaction (RT-PCR) test to have coronovirus infection after the test will be included in a treatment program of 15 sessions, at least 3 sessions per week, with bicycle ergometry. After 15 sessions, exercise capacity will be re-evaluated using the cycling test, the aforementioned triceps and grip muscle strengths, V02 max, maximum conjugate (MET), maximum work (w), borg scale, maximum heart rate, test time parameters will be saved again after treatment.
Detailed description
The cardiopulmonary exercise test was also performed on 14 individuals from the control group and 15 individuals in the patient group, and by this test, the respiratory exchange ratio (RER), anaerobic threshold (AT), maximum oxygen capacity (VO 2peak ), maximum ventilatory capacity at anaerobic threshold (VO 2AT ), carbon dioxide ventilatory equivalent (VE/CO 2 ), heart rate recovery (HRR) and heart rate recovery at 1 min (HRR1) parameters were evaluated. The test was repeated after 15 sessions of aerobic exercise training for the individuals in the COVID-19 group who participated in the cardiopulmonary exercise test, and the patients were evaluated using the same parameters.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| COVID-19 group | Active comparator | Device: Kardiopulmonary exercise test (Quark KPET C12x/T12x device connected to the Omnia version 1.6.8 COSMED system), Device: Peripheral muscle strength measurement (microFET3 (Hoggan Health Industries, Fabrication Enterprises, lnc) and JAMAR hydraulic hand dynamometer (Sammons Preston, Rolyon, Bolingbrook)., Device: Standard exercise tolerance test (a bicycle ergometer and recorded through the ergoline rehabilitation system 2 Version 1.08 SPI.), Device: Aerobic exercise training (a bicycle ergometer and recorded through the ergoline rehabilitation system 2 Version 1.08 SPI.)This group included 32 people aged 18-55 who had previously had COVID-19. Individuals' physical activity levels were measured with the IPAQ short form. Peripheral muscle strength (quadriceps muscle strength, triceps strength, hand grip strength) was measured. The exercise capacities of the individuals were evaluated with a standard exercise tolerance test using a bicycle ergometer. At the end of the test, Borg Scale, test duration, maximum heart rate, maximum work (W) and MET values were recorded. VO2peak levels and VO2peak prediction values were calculated. CPET was applied to 14 people in this group. At the end of the test, the individual's Respiratory Exchange Rate, Anaerobic Threshold, VO2peak, VO2AT (Maximum Oxygen Capacity at Respiratory Anaerobic Threshold), Carbon Dioxide Ventilation Equivalent, heart rate recovery, heart rate recovery in the 1st minute were measured. Aerobic exercise training was given to 14 people in this group. measurements were repeated. |
| control group | Active comparator | Device: Kardiopulmonary exercise test (Quark KPET C12x/T12x device connected to the Omnia version 1.6.8 COSMED system), Device: Peripheral muscle strength measurement (microFET3 (Hoggan Health Industries, Fabrication Enterprises, lnc) and JAMAR hydraulic hand dynamometer (Sammons Preston, Rolyon, Bolingbrook)., Device: Standard exercise tolerance test (a bicycle ergometer and recorded through the ergoline rehabilitation system 2 Version 1.08 SPI.)This group included 32 people aged 18-55 who had not previously had COVID-19. The physical activity levels of the individuals were measured with the IPAQ short form. Peripheral muscle strength (quadriceps muscle strength, triceps strength, hand grip strength) was measured. The exercise capacities of the individuals were evaluated with a standard exercise tolerance test using a bicycle ergometer. At the end of the test, Borg Scale, test duration, maximum heart rate, maximum work (W) and MET values were recorded. VO2peak levels and VO2peak prediction values were calculated. CPET was applied to 15 people in this group. At the end of the test, the individual's Respiratory Change Rate, Anaerobic Threshold, VO2peak, VO2AT (Maximum Oxygen Capacity at Respiratory Anaerobic Threshold), Carbon Dioxide Ventilation Equivalent, heart rate recovery, Heart rate recovery at 1 minute was measured. |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Being a healthy volunteer between the ages of 18-55
- be an independent ambulance
Key exclusion criteria (7 listed)
- -Not being willing to participate in the study
- Be over 55 years old
- Previous symptomatic or asymptomatic coronavirus infection
- Severe audio-visual loss Unstable cardiovascular, neurological or psychiatric disease
- Pregnancy status
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Kardiopulmonary exercise test (Quark KPET C12x/T12x device connected to the Omnia version 1.6.8 COSMED system)For the cardiopulmonary exercise test, a Quark KPET C12x/T12x device connected to the Omnia version 1.6.8 COSMED system, supported by analyzers that measure oxygen uptake and carbon dioxide output, and a bicycle ergometer connected to the ergoline rehab system 2 Version 1.08 SPI system were used. At the end of the test, the individual's RER , VAT, VO2peak, VO2AT, VE/CO2, HRR, HRR1 values were recorded. These values were estimated by the device based on the "wasserman extended" protocol on the Quark KPET C12x/T12x device connected to the Omnia version 1.6.8 COSMED system.The test was repeated after 15 sessions of aerobic exercise training in the Covid-19 group.This intervention was applied to 14 people in the COVID-19 group and 15 people in the control group. It was repeated at the end of 15 sessions of aerobic exercise training in the COVID-19 group. | Device | COVID-19 group, control group |
| Peripheral muscle strength measurement (microFET3 (Hoggan Health Industries, Fabrication Enterprises, lnc) and JAMAR hydraulic hand dynamometer (Sammons Preston, Rolyon, Bolingbrook).Quadriceps and triceps muscle strength was measured in kilograms using the microFET3 (Hoggan Health Industries, Fabrication Enterprises, lnc) manual muscle strength measurement device in the lower and upper extremity. Hand grip strength was evaluated in the dominant upper extremity using a JAMAR hydraulic hand dynamometer (Sammons Preston, Rolyon, Bolingbrook)This intervention was repeated for individuals in both groups at the beginning and at the end of the 15-session aerobic exercise training planned for the COVID-19 group. | Device | COVID-19 group, control group |
| Standard exercise tolerance test (a bicycle ergometer and recorded through the ergoline rehabilitation system 2 Version 1.08 SPI.)At the beginning of this test, resting pulse and blood pressure were measured and recorded. The test was performed following a bicycle ergometer protocol recommended by the American Cardiovascular and Pulmonary Rehabilitation Society. After a 2-minute warm-up period at 0 load (W), a submaximal exercise test was performed by increasing the load by 25 W in 2-minute periods. At the end of the test, exercise intensity was evaluated with the perceived difficulty level (borg scale), test duration, maximum heart rate, maximum work (W). , metabolic equivalent (MET) values were recorded. VO2peak and VO2peakpredictive levels were calculated. This test was repeated for individuals in both groups at the beginning and at the end of the 15-session aerobic exercise training planned for the COVID-19 group. | Device | COVID-19 group, control group |
| Aerobic exercise training (a bicycle ergometer and recorded through the ergoline rehabilitation system 2 Version 1.08 SPI.)Aerobic exercise training was planned for the COVID-19 group with the help of a bicycle ergometer and recorded through the ergoline rehabilitation system 2 Version 1.08 SPI. Aerobic exercise training was applied for a total of 15 sessions, at least 3 days a week, under the supervision of a physician. | Device | COVID-19 group |
Primary outcome
Assessment of Triceps muscle strength by using the Micro FET3 muscle strength device
Time frame: 3-5 weeks
Triceps and quadriceps muscle strength; It was measured in kilograms using the microFET3 (Hoggan Health Industries, Fabrication Enterprises, lnc) manual muscle strength measurement device in the dominant upper and lower extremities.
Assessment of Maximum work (watts) ın the standard exercise tolerance test using a bicycle ergometer and recording it via ergoline rehab system 2 Version 1.08 SPI.
Time frame: 3-5 weeks
In the standard exercise tolerance test, individuals were subjected to an exercise test by using a bicycle ergometer and recording it via ergoline rehab system 2 Version 1.08 SPI. The maximum work (watts) that the individuals could reach in the standard exercise tolerance test was recorded.The measurement was repeated after 15 sessions of aerobic exercise training in the Covid-19 group.
Assessment of Metabolic Equivalent (MET) in the standard exercise tolerance test using a bicycle ergometer and recording it via ergoline rehab system 2 Version 1.08 SPI.
Time frame: 3-5 weeks
In the standard exercise tolerance test, individuals were subjected to an exercise test by using a bicycle ergometer and recording it via ergoline rehab system 2 Version 1.08 SPI. The maximum work (watts) that the individuals could reach in the standard exercise tolerance test was recorded.The measurement was repeated after 15 sessions of aerobic exercise training in the Covid-19 group.
Assessment of VO2peak (ml/kg/min) in the exercise tolerance test using a bicycle ergometer and recording it via ergoline rehab system 2 Version 1.08 SPI.
Time frame: 3-5 weeks
In the standard exercise tolerance test, individuals were subjected to exercise testing using a bicycle ergometer and recorded through the ergoline rehabilitation system 2 Version 1.08 SPI. VO2peak was calculated based on the maximum work (watts) that individuals could achieve in the standard exercise tolerance test.The measurement was repeated after 15 sessions of aerobic exercise training in the Covid-19 group
Assessment of VO2peakpredictive (%) in the standard exercise tolerance test using a bicycle ergometer and recording it via ergoline rehab system 2 Version 1.08 SPI.
Time frame: 3-5 weeks
In the standard exercise tolerance test, individuals were subjected to exercise testing using a bicycle ergometer and recorded through the ergoline rehabilitation system 2 Version 1.08 SPI. VO2peakpredictive was calculated based on the maximum work (watts) that individuals could achieve in the standard exercise tolerance test.The measurement was repeated after 15 sessions of aerobic exercise training in the Covid-19 group.
Assessment of Hand grip strength (kg) by using a JAMAR hydraulic hand dynamometer (Sammons Preston, Rolyon, Bolingbrook).
Time frame: 3-5 weeks
Hand grip strength was evaluated in the dominant upper extremity using a JAMAR hydraulic hand dynamometer (Sammons Preston, Rolyon, Bolingbrook). Two consecutive tests were performed on individuals in a sitting position with shoulders in adduction and neutral rotation, elbows in 90 degrees of flexion, forearm and wrist in 0-30 degrees of extension and 0-15 degrees of ulnar deviation, and the highest grip strength was recorded and evaluated in kilograms.The measurement was repeated after 15 sessions of aerobic exercise training in the Covid-19 group.
Assessment of Exchange Ratio(RER ) by using cardiopulmonary exercise test, a Quark KPET C12x/T12x device connected to the Omnia version 1.6.8 COSMED system,
Time frame: 3-5 weeks
For the cardiopulmonary exercise test, a Quark KPET C12x/T12x device connected to the Omnia version 1.6.8 COSMED system, supported by analyzers that measure oxygen uptake and carbon dioxide output, and a bicycle ergometer connected to the ergoline rehab system 2 Version 1.08 SPI system were used. At the end of the test, the individual's RER , VAT, VO2peak, VO2AT, VE/CO2, HRR, HRR1 values were recorded. These values were estimated by the device based on the "wasserman extended" protocol on the Quark KPET C12x/T12x device connected to the Omnia version 1.6.8 COSMED system.The test was repeated after 15 sessions of aerobic exercise training in the Covid-19 group
Assessment of Anaerobik Treshold (VAT) by using cardiopulmonary exercise test with a Quark KPET C12x/T12x device connected to the Omnia version 1.6.8 COSMED system,
Time frame: 3-5 weeks
For the cardiopulmonary exercise test, a Quark KPET C12x/T12x device connected to the Omnia version 1.6.8 COSMED system, supported by analyzers that measure oxygen uptake and carbon dioxide output, and a bicycle ergometer connected to the ergoline rehab system 2 Version 1.08 SPI system were used. At the end of the test, the individual's RER , VAT, VO2peak, VO2AT, VE/CO2, HRR, HRR1 values were recorded. These values were estimated by the device based on the "wasserman extended" protocol on the Quark KPET C12x/T12x device connected to the Omnia version 1.6.8 COSMED system.The test was repeated after 15 sessions of aerobic exercise training in the Covid-19 group
Assessment of Maximum Oxygen Capacity (VO2peak) by using cardiopulmonary exercise test with a Quark KPET C12x/T12x device connected to the Omnia version 1.6.8 COSMED system,
Time frame: 3-5 weeks
For the cardiopulmonary exercise test, a Quark KPET C12x/T12x device connected to the Omnia version 1.6.8 COSMED system, supported by analyzers that measure oxygen uptake and carbon dioxide output, and a bicycle ergometer connected to the ergoline rehab system 2 Version 1.08 SPI system were used At the end of the test, the individual's RER , VAT, VO2peak, VO2AT, VE/CO2, HRR, HRR1 values were recorded. These values were estimated by the device based on the "wasserman extended" protocol on the Quark KPET C12x/T12x device connected to the Omnia version 1.6.8 COSMED system.The test was repeated after 15 sessions of aerobic exercise training in the Covid-19 group
Assessment of Maximum Oxygen Capacity at Ventilatory Anaerobic Threshold (VO2AT) by using cardiopulmonary exercise test with a Quark KPET C12x/T12x device connected to the Omnia version 1.6.8 COSMED system,
Time frame: 3-5 weeks
For the cardiopulmonary exercise test, a Quark KPET C12x/T12x device connected to the Omnia version 1.6.8 COSMED system, supported by analyzers that measure oxygen uptake and carbon dioxide output, and a bicycle ergometer connected to the ergoline rehab system 2 Version 1.08 SPI system were used. At the end of the test, the individual's RER , VAT, VO2peak, VO2AT, VE/CO2, HRR, HRR1 values were recorded. These values were estimated by the device based on the "wasserman extended" protocol on the Quark KPET
Assessment of Carbon Dioxide Ventilatory Equivalent (VE/CO2) by using cardiopulmonary exercise test with a Quark KPET C12x/T12x device connected to the Omnia version 1.6.8 COSMED system,
Time frame: 3-5 weeks
For the cardiopulmonary exercise test, a Quark KPET C12x/T12x device connected to the Omnia version 1.6.8 COSMED system, supported by analyzers that measure oxygen uptake and carbon dioxide output, and a bicycle ergometer connected to the ergoline rehab system 2 Version 1.08 SPI system were used. At the end of the test, the individual's RER , VAT, VO2peak, VO2AT, VE/CO2, HRR, HRR1 values were recorded. These values were estimated by the device based on the "wasserman extended" protocol on the Quark KPET
Assessment of Heart Rate Recovery (HRR) by using cardiopulmonary exercise test with a Quark KPET C12x/T12x device connected to the Omnia version 1.6.8 COSMED system,
Time frame: 3-5 weeks
For the cardiopulmonary exercise test, a Quark KPET C12x/T12x device connected to the Omnia version 1.6.8 COSMED system, supported by analyzers that measure oxygen uptake and carbon dioxide output, and a bicycle ergometer connected to the ergoline rehab system 2 Version 1.08 SPI system were used. At the end of the test, the individual's RER , VAT, VO2peak, VO2AT, VE/CO2, HRR, HRR1 values were recorded. These values were estimated by the device based on the "wasserman extended" protocol on the Quark KPET
Assessment of Heart Rate Recovery at first minute (HRR1) by using cardiopulmonary exercise test with a Quark KPET C12x/T12x device connected to the Omnia version 1.6.8 COSMED system,
Time frame: 3-5 weeks
For the cardiopulmonary exercise test, a Quark KPET C12x/T12x device connected to the Omnia version 1.6.8 COSMED system, supported by analyzers that measure oxygen uptake and carbon dioxide output, and a bicycle ergometer connected to the ergoline rehab system 2 Version 1.08 SPI system were used. At the end of the test, the individual's RER , VAT, VO2peak, VO2AT, VE/CO2, HRR, HRR1 values were recorded. These values were estimated by the device based on the "wasserman extended" protocol on the Quark KPET
Assessment of quadriceps muscle strength by using the Micro FET3 muscle strength device
Time frame: 3-5 weeks
Triceps and quadriceps muscle strength; It was measured in kilograms using the microFET3 (Hoggan Health Industries, Fabrication Enterprises, lnc) manual muscle strength measurement device in the dominant upper and lower extremities.
6 secondary outcomes
Assessment of Physical activity by using the International Physical Activity Questionnaire (IPAQ)
Time frame: 3-5 weeks
Assessment of Test Duration (min) in the standard exercise tolerance test using a bicycle ergometer and recording it via ergoline rehab system 2 Version 1.08 SPI.
Time frame: 3-5 weeks
Assessment of Perceived Difficulty by using the Borg Scale
Time frame: 3-5 weeks
Assessment of Maximum heart rate (beats/min) in the standard exercise tolerance test using a bicycle ergometer and recording it via ergoline rehab system 2 Version 1.08 SPI.
Time frame: 3-5 weeks
Assessment of Systolic and diastolic blood pressure (mmHg) by using a blood pressure monitor
Time frame: 3-5 weeks
Assessment of resting heart rate (beats/min) by using a a pulse oximeter
Time frame: 3-5 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Feb 2024.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Kardiopulmonary exercise test (Quark KPET C12x/T12x device connected to the Omnia version 1.6.8 COSMED system), Peripheral muscle strength measurement (microFET3 (Hoggan Health Industries, Fabrication Enterprises, lnc) and JAMAR hydraulic hand dynamometer (Sammons Preston, Rolyon, Bolingbrook). and Standard exercise tolerance test (a bicycle ergometer and recorded through the ergoline rehabilitation system 2 Version 1.08 SPI.) in people with COVID-19 Pneumonia and COVID-19, run by Selda Sarıkaya at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 22 Feb 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Assessment of Triceps muscle strength by using the Micro FET3 muscle strength device (time frame: 3-5 weeks). The study lists 14 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Feb 2024.