Clinical trial NCT05231408: Effects of Aerobic Exercise in Patients With Post COVID-19
Official title: Effects of High-Intensity Interval Aerobic Exercise Training on Oxygen Consumption Muscle Oxygenation and Physical Activity Level in Patients With Post COVID-19
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: COVID-19
Keywords: COVID-19
aerobic exercise training
muscle oxygenation
oxygen consumption
physical activity
Lead sponsor: Gazi University
Sponsor class: OTHER
First posted: 2022-02-09
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: Many structures and organs are adversely affected after COVID-19. The most obvious and common problem is lung involvement. In the pathology report of the patients, it has been shown that there are changes such as diffuse alveolar damage, bronchiolitis and interstitial fibrosis. The most prominent effect of COVID-19 in patients with reduced lung functions is reduced diffusion capacity. While the disease severity worsens, pulmonary fibrosis becomes more pronounced in cases. The complaints of dyspnea and fatigue of patients after discharged continue. Inspiratory and expiratory respiratory muscle weakness are observed in more than 50% of patients with COVID-19, measured in the first month after the discharged. This respiratory muscle weakness is associated with myopathy due to hypoxemia, oxygen support, prolonged bed rest and corticosteroid use, regardless of disease severity.

It is seen that these patients with COVID-19 need exercise training because of lung involvement, decreased exercise capacity and persistence of some symptom complaints after the discharged.

Detailed description: Patients with COVID-19 have not only reduced respiratory capacity, but also diminished muscle strength, exercise capacity, weakness cardiac system. In parallel with aforementioned, physical activity level and quality of life get worse in this patients. Therefore, the patients with COVID-19 need exercise training after the discharged. In the literature, the achievement of exercise training in many aspects such as exercise capacity, lung health, respiratory muscle strength, dyspnea has been proven in many diseases such as chronic obstructive pulmonary disease and heart failure.

Effects of high-intensity interval aerobic exercise training on oxygen consumption, muscle oxygenation, physical activity level, pulmonary function, functional exercise capacity, respiratory and peripheral strength, inspiratory muscle endurance, functional status, dyspnea, fatigue perception and quality of life have not been investigated in literature in patients with COVID-19. According to inclusion and exclusion criteria, 15 patients for training group and 15 patients for control group will be included. All assessments will be completed in two days before and after eight weeks training.

Primary outcome measurement will be oxygen consumption (cardiopulmonary exercise test).

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

Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

Patients with

* 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

Primary outcomes:
measure: Oxygen consumption
timeFrame: First day
Secondary outcomes:
measure: Muscle Oxygenation
timeFrame: First and second day
measure: Physical activity level
timeFrame: Second day
measure: Pulmonary function
timeFrame: Second day
measure: Functional exercise capacity
timeFrame: Second day
measure: Respiratory muscle strength
timeFrame: Second day
measure: Peripheral muscle strength
timeFrame: Second day
measure: Inspiratory muscle endurance
timeFrame: Second day
measure: Functional status
timeFrame: First day
measure: Dyspnea perception
timeFrame: First day
measure: Fatigue
timeFrame: First day
measure: Life Quality
timeFrame: Second day
measure: Borg Scale
timeFrame: During exercise training
measure: Modified Borg Scale
timeFrame: During the exercise tests
Other outcomes:
Locations:
city: Ankara
country: Turkey
facility: Gazi University, Faculty of Health Sciences, Department of Physiotherapy and Rehabilitation, Cardiopulmonary Rehabilitation Clinic
Study officials:
affiliation: Gazi University
name: Ece BAYTOK, MsC
role: STUDY_CHAIR
affiliation: Gazi University
name: Başak Kavalcı KOL, MsC
role: PRINCIPAL_INVESTIGATOR
affiliation: Gazi University
name: Nilgün Yılmaz DEMİRCİ, Assoc.Prof
role: PRINCIPAL_INVESTIGATOR
affiliation: Gazi University
name: Meral Boşnak GÜÇLÜ, Prof. Dr
role: STUDY_DIRECTOR
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