Clinical trial NCT04961255: Effects of Post-COVID-19 on Quadriceps Femoral Muscle-tendon Unit
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
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Post-COVID-19
Healthy Participants
Keywords: COVID-19
muscle
tendon
cytokines
electrodiagnosis
fatigue
strength
peripheral oxygen extraction
Lead sponsor: University of Brasilia
Sponsor class: OTHER
First posted: 2021-07-14
Enrollment: 90
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

Brief 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.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Blood biomarkers
timeFrame: 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.
measure: Sit to stand test
timeFrame: 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.
measure: Electrodiagnostic stimulus test
timeFrame: 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.
measure: Body composition
timeFrame: 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.
measure: Muscle force
timeFrame: 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.
measure: Peripheral oxygen extraction
timeFrame: 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.
measure: Surface electromyographic activity
timeFrame: 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.
measure: Muscle architecture
timeFrame: 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.
measure: Properties of the patellar tendon
timeFrame: 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.
measure: Muscle fatigue
timeFrame: 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.
measure: Assessment of perceived exertion during the fatigue protocol
timeFrame: 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.
measure: Fatigue severity analysis
timeFrame: 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.
Secondary outcomes:
Other outcomes:
Locations:
city: Brasília
country: Brazil
facility: University of Brasilia
state: Distrito Federal
Study officials:
affiliation: University of Brasilia
name: João LQ Durigan, PhD
role: PRINCIPAL_INVESTIGATOR
References: