Investigation of the Muscle Oxygenation in Patients With Post COVID-19 Syndrome

Comparison of the Muscle Oxygenation During Submaximal and Maximal Exercise Tests in Patients With Post COVID-19 Syndrome

More than 60% of patients infected with COVID-19 have long-term symptoms. These symptoms are associated with common ground-glass opacities on computed tomography scans and chest radiographs. The pathophysiology of long-term persistent symptoms is largely unknown, but hypoxia and hypoxic tissue damage, decreased pulmonary diffusion capacity, ventilation-perfusion mismatch, and lung fibrosis caused by COVID-19-associated pneumonia are thought to cause long-term symptoms. Desaturation may occur during exercise due to hypoxia, pneumonia and lung involvement in patients with post-COVID syndrome. Oxygenation of peripheral muscles may decrease due to hypoxemia, but there is not enough study on this subject yet.

Study Overview

• Status: Completed
• Conditions: COVID-19

Detailed Description

Post-COVID syndrome is defined as unexplained signs or symptoms that develop during or after infection with COVID-19 and persist for 12 weeks. Long-term symptoms include fatigue, dyspnea, impaired exercise and lung function.It is important to understand physiological mechanisms underlying persistent dyspnea, fatigue, and impaired exercise capacity after COVID-19 infection to develop appropriate rehabilitation interventions while improving these symptoms. The pathophysiology of long-term persistent symptoms is largely unknown, however hypoxia and hypoxic tissue damage caused by COVID-19-associated pneumonia, decreased pulmonary diffusion capacity, ventilation-perfusion mismatch and lung fibrosis have been hypothesized. The effect of hypoxemia associated with COVID-19 on oxygenation of peripheral muscles and muscle oxygenation at submaximal and maximal exercise intensity has not been investigated, yet.

The aim of our study is to evaluate and compare quadriceps femoris muscle oxygenation in submaximal and maximal exercise tests in patients with post-COVID syndrome.

Patients referred from Gazi University, Faculty of Medicine, Department of Chest Diseases for pulmonary rehabilitation to Cardiopulmonary Rehabilitation Unit located in the Faculty of Health Sciences were recruited, Department of Physiotherapy and Rehabilitation, between March 2022 and May 2023. Muscle oxygenation during six-minute walk test and cardiopulmonary exercise test on two different days was measured and compared.

• Study Type: Observational
• Enrollment (Actual): 39

Contacts and Locations

Study Locations

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

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Probability Sample

Study Population

Thirty eight patients with pulmonary involvement post-COVID syndrome were recruited for the study. Pulmonary involvement of the patients was determined by a pulmonologist according to the results of computed tomography.Patients referred from Gazi University, Faculty of Medicine, Department of Chest Diseases for pulmonary rehabilitation to Cardiopulmonary Rehabilitation Unit located in the Faculty of Health Sciences were recruited, Department of Physiotherapy and Rehabilitation.

Description

Inclusion Criteria:

• Between the ages of 18-75
• Diagnosed with pulmonary involvement COVID-19
• Volunteer to participate in the study

Exclusion Criteria:

• Body mass index >35 kg/m2
• Acute pulmonary exacerbation, acute upper or lower respiratory tract infection
• Aortic stenosis, complex arrhythmia, aortic aneurysm
• Serious neurological, neuromuscular, orthopedic, other systemic diseases or other diseases affecting physical functions
• Cognitive impairment that causes difficulty in understanding and following exercise test instructions
• Participated in a planned exercise program in the last three months
• Uncontrolled hypertension and/or diabetes mellitus, heart failure and cardiovascular disease
• Contraindication for exercise testing and/or exercise training according to the American College of Sports Medicine

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Measurement of muscle oxygenation (SmO2)	The saturation of oxygen in muscles (SmO2) was evaluated using a non-invasive method Moxy® device (Moxy®, Fortiori Design LLC, Minnesota, USA).	through study completion, an average of 18 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Maximal exercise capacity	Cardiopulmonary Exercise Test	through study completion, an average of 18 months
Submaximal exercise capacity	Six minute walk test	through study completion, an average of 18 months
Peripheral Muscle Strength	Hand held dynamometer	through study completion, an average of 18 months
Functional Status	Post-COVID-19 Functional Status scale (PCFS)	through study completion, an average of 18 months

Collaborators and Investigators

• Sponsor: Gazi University
• Investigators: Principal Investigator: Nilgün YILMAZ DEMİRCİ, Assoc. Prof., Gazi University; Study Director: Meral BOŞNAK GÜÇLÜ, Prof. Dr., Gazi University; Principal Investigator: Başak KAVALCI KOL, Pt. MSc., Gazi University; Principal Investigator: Ece BAYTOK, Pt. MSc., Gazi University

Study record dates

Study Major Dates

• Study Start (Actual): February 25, 2022
• Primary Completion (Actual): June 15, 2023
• Study Completion (Actual): July 20, 2023

Study Registration Dates

• First Submitted: July 21, 2023
• First Submitted That Met QC Criteria: July 21, 2023
• First Posted (Actual): July 24, 2023

Study Record Updates

• Last Update Posted (Actual): August 2, 2023
• Last Update Submitted That Met QC Criteria: July 31, 2023
• Last Verified: July 1, 2023

More Information

Terms related to this study

• Keywords: COVID-19; oxygen consumption
• Additional Relevant MeSH Terms: Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Virus Diseases; Infections; Respiratory Tract Infections; Respiratory Tract Diseases; Pneumonia, Viral; Pneumonia; Lung Diseases; COVID-19
• Other Study ID Numbers: Gazi University 5

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