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临床试验/NCT05957575
NCT05957575已完成不适用

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

Gazi University1 个研究点 分布在 1 个国家目标入组 39 人开始时间: 2022年2月25日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
39
试验地点
1
主要终点
Measurement of muscle oxygenation (SmO2)

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

年龄范围
18 Years 至 75 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

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

排除标准

  • 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

结局指标

主要结局

Measurement of muscle oxygenation (SmO2)

时间窗: 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).

次要结局

  • Submaximal exercise capacity(through study completion, an average of 18 months)
  • Functional Status(through study completion, an average of 18 months)
  • Maximal exercise capacity(through study completion, an average of 18 months)
  • Peripheral Muscle Strength(through study completion, an average of 18 months)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Meral Boşnak Güçlü

Study director, PT, PhD, Prof.Dr. Faculty of Health Sciences, Department of Physiotherapy and Rehabilitation, Head of Cardiopulmonary Rehabilitation Clinic

Gazi University

研究点 (1)

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