Effects of Post-COVID-19 on Quadriceps Femoral Muscle-tendon Unit

Healthy Participants Clinical Trial

Official title:

Effects of Post-COVID-19 on Neural Activation and Architecture of the Quadriceps Femoral Muscle-tendon Unit and Its Correlation With Inflammatory Markers

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04961255
• Other study ID #: CAAE: 45043821.0.0000.8093
• Status: Recruiting
• Start date: August 24, 2021
• Est. completion date: December 30, 2024

Study information

• Verified date: December 2023
• Source: University of Brasilia
• Contact: Rita CM Durigan, PhD
• Phone: +55 61 3107-8450
• Email: marqueti[@]gmail.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

The physiological/biomechanical characteristics related to muscle and tendon architecture and their possible relationship with the loss of muscle strength and fatigue in patients who were infected with COVID-19 are totally unknown. The aim of this study is to evaluate inflammatory markers, the isometric maximum voluntary force of the knee extensor torque, muscle fatigue, neuromuscular adaptations, muscle architecture, tendinous properties of quadriceps components, oxygen extraction, and body composition in participants after diagnosis with Covid-19 who had moderate and severe levels of involvement compared to a healthy control group.

Description:

The groups will be composed of participants who had COVID-19, except for the control group, which will be composed of healthy participants who did not have COVID-19. Participants will be divided into: (1) control group, (2) COVID-19 positive participants who had moderate symptoms, (3) COVID-19 positive participants who had severe symptoms. Participants will be recruited from 21 days after the onset of symptoms, the period recommended by the scientific community that the patient no longer transmits severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2). After recruitment, 4 evaluations will be carried out over 1 year.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 90
• Est. completion date: December 30, 2024
• Est. primary completion date: August 30, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

Inclusion Criteria:

• Control group:

• The control group will include healthy participants, aged 18 and 80 years, who had not tested positive for COVID-19.

• COVID-19 positive participants who had moderate symptoms group:

• Female and male participants, aged between 18 and 80 years, who had Molecular test (RT-PCR) or serological test, which assesses whether the samples are reactive to immunoglobulin M (IgM) and immunoglobulin G (IgG) antibodies, positive for COVID-19;

• Presence of some of the following symptoms, without the need for hospitalization:

dry cough, runny nose, sore throat, diffuse body pain, persistent hyperthermia, no hypoxemia.

• COVID-19 positive participants who had severe symptoms group:

• Female and male participants, aged between 18 and 80 years, who had Molecular test (RT-PCR) or serological test (which assesses whether the samples are reactive to IgM and IgG antibodies) positive for COVID-19;

• Presence of hypoxemia (peripheral oxygen saturation - SPO2 = 93%) requiring hospitalization with or without intubation, in addition to the symptoms described for the COVID-19 positive participants who had moderate symptoms group.

Exclusion Criteria:

• Body Mass Index (BMI) = 35 kg/m2;

• Pregnancy;

• Pain, swelling, dermal damage, deformity, or amputation in the regions to be examined;

• Diagnosis of ankylosing spondylitis, rheumatoid arthritis, severe heart disease, advanced chronic obstructive pulmonary disease, cognitive impairment, chemical dependency, psychiatric illness, or behavioral that makes it difficult to cooperate with the procedures.

Related Conditions & MeSH terms

• COVID-19
• Healthy Participants

Locations

Country	Name	City	State
Brazil	University of Brasilia	Brasília	Distrito Federal

Sponsors (1)

Lead Sponsor	Collaborator
University of Brasilia

Country where clinical trial is conducted

Brazil, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Blood biomarkers	Blood biomarkers including metalloproteinase 9, interleukin-6, interleukin-8 and interleukin-10, interleukin 1 beta, tumor necrosis factor alpha type, nitric oxide, as well as creatine kinase will be collected in blood samples by venipuncture in the vein brachial, in heparinized tubes with separating gel using the vacutainer system with ethylenediaminetetraacetic acid (EDTA). The samples will be stored and later analyzed using appropriate techniques.	Change from baseline 1 (days 21-30) to assessments 2 (days 31-90), 3 (days 91-180), and 4 (days 181 to 360) for groups composed of COVID-19 positive participants. The Control group will be assessed only at baseline.
Primary	Sit to stand test	To carry out the test will be used a stopwatch and a chair with the back against a wall, seat height 43 cm from the floor and without armrest. The test consists of measuring how many times the participant can get up and sit down from a chair (counting as a movement) in a period of 30 seconds.	Change from baseline 1 (days 21-30) to assessments 2 (days 31-90), 3 (days 91-180), and 4 (days 181 to 360) for groups composed of COVID-19 positive participants. The Control group will be assessed only at baseline.
Primary	Electrodiagnostic stimulus test	The quadriceps femoris, gastrocnemius, soleus and tibialis anterior muscles will be evaluated. At the muscle motor point, the values of rheobase, chronaxia and accommodation will be investigated.	Change from baseline 1 (days 21-30) to assessments 2 (days 31-90), 3 (days 91-180), and 4 (days 181 to 360) for groups composed of COVID-19 positive participants. The Control group will be assessed only at baseline.
Primary	Body composition	Body composition will be estimated using dual x-ray absorptiometry. Fat mass and fat-free mass will be expressed in absolute values.	Change from baseline 1 (days 21-30) to assessments 2 (days 31-90), 3 (days 91-180), and 4 (days 181 to 360) for groups composed of COVID-19 positive participants. The Control group will be assessed only at baseline.
Primary	Muscle force	Muscle force will be assessed by muscle force changes, based on the torque generated during maximum voluntary contraction.	Change from baseline 1 (days 21-30) to assessments 2 (days 31-90), 3 (days 91-180), and 4 (days 181 to 360) for groups composed of COVID-19 positive participants. The Control group will be assessed only at baseline.
Primary	Peripheral oxygen extraction	The assessment of peripheral oxygen extraction will be performed both in rest and during voluntary contraction. The evaluation will be carried out by means of near-infrared spectroscopy (NIRS or near infrared spectroscopy).	Change from baseline 1 (days 21-30) to assessments 2 (days 31-90), 3 (days 91-180), and 4 (days 181 to 360) for groups composed of COVID-19 positive participants. The Control group will be assessed only at baseline.
Primary	Surface electromyographic activity	Electromyographic activity of each superficial component of the quadriceps muscle both in rest and during voluntary contraction.	Change from baseline 1 (days 21-30) to assessments 2 (days 31-90), 3 (days 91-180), and 4 (days 181 to 360) for groups composed of COVID-19 positive participants. The Control group will be assessed only at baseline.
Primary	Muscle architecture	Muscle architecture analyzes will be performed using ultrasound at rest and during voluntary contraction. The muscle volume of the knee extensors, muscle thickness, pennation angle, fascicle length and muscle echogenicity will be evaluated.	Change from baseline 1 (days 21-30) to assessments 2 (days 31-90), 3 (days 91-180), and 4 (days 181 to 360) for groups composed of COVID-19 positive participants. The Control group will be assessed only at baseline.
Primary	Properties of the patellar tendon	The morphological, material and mechanical properties will be evaluated based from the elongation of the patellar tendon during maximum voluntary contraction.	Change from baseline 1 (days 21-30) to assessments 2 (days 31-90), 3 (days 91-180), and 4 (days 181 to 360) for groups composed of COVID-19 positive participants. The Control group will be assessed only at baseline.
Primary	Muscle fatigue	Quadriceps muscle fatigue will be assessed in each leg after consecutive maximal isometric voluntary contractions of the quadriceps muscle.	Change from baseline 1 (days 21-30) to assessments 2 (days 31-90), 3 (days 91-180), and 4 (days 181 to 360) for groups composed of COVID-19 positive participants. The Control group will be assessed only at baseline.
Primary	Assessment of perceived exertion during the fatigue protocol	Assessment of perceived exertion will be analyzed before, during, and after the performance of maximum voluntary isometric contractions performed to analyze muscle fatigue using the BORG scale of perceived exertion.	Change from baseline 1 (days 21-30) to assessments 2 (days 31-90), 3 (days 91-180), and 4 (days 181 to 360) for groups composed of COVID-19 positive participants. The Control group will be assessed only at baseline.
Primary	Fatigue severity analysis	Fatigue severity analysis will be assessed using the fatigue severity scale.	Change from baseline 1 (days 21-30) to assessments 2 (days 31-90), 3 (days 91-180), and 4 (days 181 to 360) for groups composed of COVID-19 positive participants. The Control group will be assessed only at baseline.