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Completed

NCT Number: NCT05957575

Investigation of the Muscle Oxygenation 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.

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Key information

Conditions

COVID-19 Coronaviridae Infections Coronavirus Infections Infections Lung Diseases Nidovirales Infections Pneumonia Pneumonia, Viral RNA Virus Infections Respiratory Tract Diseases Respiratory Tract Infections Virus Diseases

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Gazi University, Faculty of Health Sciences, Department of Physiotherapy and Rehabilitation, Cardiopulmonary Rehabilitation Clinic

Ankara, 06560, Turkey (Türkiye)

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. Measurement of muscle oxygenation (SmO2)

    Time frame: through study completion, an average of 18 months

    The saturation of oxygen in muscles (SmO2) was evaluated using a non-invasive method Moxy® device (Moxy®, Fortiori Design LLC, Minnesota, USA).

Secondary outcomes

  1. Maximal exercise capacity

    Time frame: through study completion, an average of 18 months

    Cardiopulmonary Exercise Test

  2. Submaximal exercise capacity

    Time frame: through study completion, an average of 18 months

    Six minute walk test

  3. Peripheral Muscle Strength

    Time frame: through study completion, an average of 18 months

    Hand held dynamometer

  4. Functional Status

    Time frame: through study completion, an average of 18 months

    Post-COVID-19 Functional Status scale (PCFS)

Sponsors and collaborators

Lead sponsor

Gazi University

Other

Registry information

Official study title

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

Important dates

Study start
2022
Primary completion
2023
Study completion
2023
First posted
Jul 24, 2023
Registry last updated
Aug 2, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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