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

December 4, 2023 updated by: João Luiz Q. Durigan, University of Brasilia

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

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.

Study Overview

Status

Recruiting

Conditions

Detailed 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.

Study Type

Observational

Enrollment (Estimated)

90

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Brazil
    • Distrito Federal
      • Brasília, Distrito Federal, Brazil, 72220-900

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Sampling Method

Non-Probability Sample

Study Population

Female and male participants aged between 18 and 80 years who had tested positive for COVID-19 will be included in this study. In addition, the control group will include healthy participants who had not tested positive for COVID-19.

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Control group
Healthy individuals will be evaluated only once throughout the study. Inflammatory markers, the isometric maximum voluntary force of knee extensor torque, muscle fatigue, neuromuscular adaptations, muscle architecture, quadriceps tendon properties, peripheral oxygen extraction, and body composition will be evaluated.
COVID-19 positive participants who had moderate symptoms group

These participants will be evaluated 4 times throughout the study.

Baseline 1: This will be performed between 21 to 30 days after the onset of symptoms of COVID-19 infection.

Assessment 2: This will be performed between 31 to 90 days after the onset of symptoms of COVID-19 infection.

Assessment 3: This will be carried out between 91 and 180 days after the onset of symptoms of COVID-19 infection.

Assessment 4: This will be performed between 181 to 360 days after the onset of symptoms of COVID-19 infection.

Inflammatory markers, the isometric maximum voluntary force of knee extensor torque, muscle fatigue, neuromuscular adaptations, muscle architecture, quadriceps tendon properties, peripheral oxygen extraction, and body composition will be evaluated in each assessment.
COVID-19 positive participants who had severe symptoms group

These participants will be evaluated 4 times throughout the study.

Baseline 1: This will be performed between 21 to 30 days after the onset of symptoms of COVID-19 infection.

Assessment 2: This will be performed between 31 to 90 days after the onset of symptoms of COVID-19 infection.

Assessment 3: This will be carried out between 91 and 180 days after the onset of symptoms of COVID-19 infection.

Assessment 4: This will be performed between 181 to 360 days after the onset of symptoms of COVID-19 infection.

Inflammatory markers, the isometric maximum voluntary force of knee extensor torque, muscle fatigue, neuromuscular adaptations, muscle architecture, quadriceps tendon properties, peripheral oxygen extraction, and body composition will be evaluated in each assessment.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Blood biomarkers
Time Frame: 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.
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.
Sit to stand test
Time Frame: 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.
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.
Electrodiagnostic stimulus test
Time Frame: 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.
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.
Body composition
Time Frame: 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.
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.
Muscle force
Time Frame: 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.
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.
Peripheral oxygen extraction
Time Frame: 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.
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.
Surface electromyographic activity
Time Frame: 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.
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.
Muscle architecture
Time Frame: 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.
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.
Properties of the patellar tendon
Time Frame: 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.
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.
Muscle fatigue
Time Frame: 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.
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.
Assessment of perceived exertion during the fatigue protocol
Time Frame: 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.
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.
Fatigue severity analysis
Time Frame: 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.
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.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Brasilia

Investigators

  • Principal Investigator: João LQ Durigan, PhD, University of Brasilia

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 24, 2021

Primary Completion (Estimated)

August 30, 2024

Study Completion (Estimated)

December 30, 2024

Study Registration Dates

First Submitted

July 6, 2021

First Submitted That Met QC Criteria

July 12, 2021

First Posted (Actual)

July 14, 2021

Study Record Updates

Last Update Posted (Estimated)

December 5, 2023

Last Update Submitted That Met QC Criteria

December 4, 2023

Last Verified

December 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CAAE: 45043821.0.0000.8093

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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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