Clinical trial NCT06272266: The Aerobic Exercise Capacity and Muscle Strenght in Individuals With COVID-19
Official title: Determination of Exercise Capacity and Muscle Strenght in Individuals With COVID-19, the Effect of Aerobic Exercise Training.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: COVID-19 Pneumonia
COVID-19
Keywords: coronavirus infection
aerobic capacity
cardiopulmonary rehabilitation
Lead sponsor: Bulent Ecevit University
Sponsor class: OTHER
Collaborators: name: Zonguldak Bulent Ecevit University
First posted: 2024-02-22
Enrollment: 41
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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. 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.

Eligibility criteria: Inclusion Criteria:

* Being a healthy volunteer between the ages of 18-55
* be an independent ambulance

Exclusion Criteria:

* -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

Primary outcomes:
measure: Assessment of Triceps muscle strength by using the Micro FET3 muscle strength device
timeFrame: 3-5 weeks
measure: 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.
timeFrame: 3-5 weeks
measure: 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.
timeFrame: 3-5 weeks
measure: 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.
timeFrame: 3-5 weeks
measure: 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.
timeFrame: 3-5 weeks
measure: Assessment of Hand grip strength (kg) by using a JAMAR hydraulic hand dynamometer (Sammons Preston, Rolyon, Bolingbrook).
timeFrame: 3-5 weeks
measure: 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,
timeFrame: 3-5 weeks
measure: 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,
timeFrame: 3-5 weeks
measure: 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,
timeFrame: 3-5 weeks
measure: 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,
timeFrame: 3-5 weeks
measure: 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,
timeFrame: 3-5 weeks
measure: 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,
timeFrame: 3-5 weeks
measure: 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,
timeFrame: 3-5 weeks
measure: Assessment of quadriceps muscle strength by using the Micro FET3 muscle strength device
timeFrame: 3-5 weeks
Secondary outcomes:
measure: Assessment of Physical activity by using the International Physical Activity Questionnaire (IPAQ)
timeFrame: 3-5 weeks
measure: 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.
timeFrame: 3-5 weeks
measure: Assessment of Perceived Difficulty by using the Borg Scale
timeFrame: 3-5 weeks
measure: 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.
timeFrame: 3-5 weeks
measure: Assessment of Systolic and diastolic blood pressure (mmHg) by using a blood pressure monitor
timeFrame: 3-5 weeks
measure: Assessment of resting heart rate (beats/min) by using a a pulse oximeter
timeFrame: 3-5 weeks
Other outcomes:
Locations:
city: Zonguldak
country: Turkey
facility: Zonguldak Bülent Ecevit University
Study officials:
References: