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

NCT05957575 | Completed

• 1 other identifier: Gazi University 5
• Study Type: observational
• Target: 39
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

COVID-19

Keywords

COVID-19; oxygen consumption

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (4)

• Maximal exercise capacity

  through study completion, an average of 18 months

• Submaximal exercise capacity

  through study completion, an average of 18 months

• Peripheral Muscle Strength

  through study completion, an average of 18 months

• Functional Status

  through study completion, an average of 18 months

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Gazi University: lead

Study Sites (1)

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

Ankara, 06560, Turkey (Türkiye)

Location

MeSH Terms

Conditions

COVID-19

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases

Study Officials

• Başak KAVALCI KOL, Pt. MSc.

  Gazi University

  PRINCIPAL INVESTIGATOR

• Ece BAYTOK, Pt. MSc.

  Gazi University

  PRINCIPAL INVESTIGATOR

• Nilgün YILMAZ DEMİRCİ, Assoc. Prof.

  Gazi University

  PRINCIPAL INVESTIGATOR

• Meral BOŞNAK GÜÇLÜ, Prof. Dr.

  Gazi University

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 2 Days
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Study director, PT, PhD, Prof.Dr. Faculty of Health Sciences, Department of Physiotherapy and Rehabilitation, Head of Cardiopulmonary Rehabilitation Clinic

Study Record Dates

• First Submitted: July 21, 2023
• First Posted: July 24, 2023
• Study Start: February 25, 2022
• Primary Completion: June 15, 2023
• Study Completion: July 20, 2023
• Last Updated: August 2, 2023

Record last verified: 2023-07

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)