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

NCT ID: NCT04961255

Last Updated: 2023-12-05

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

RECRUITING

Total Enrollment

90 participants

Study Classification

OBSERVATIONAL

Study Start Date

2021-08-24

Study Completion Date

2024-12-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Post-COVID-19 Healthy Participants

Keywords

Explore important study keywords that can help with search, categorization, and topic discovery.

COVID-19 muscle tendon cytokines electrodiagnosis fatigue strength peripheral oxygen extraction

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

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.

No interventions assigned to this group

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.

No interventions assigned to this group

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.

No interventions assigned to this group

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

University of Brasilia

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

João Luiz Q. Durigan

Physical Therapist, Assistant Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

João LQ Durigan, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Brasilia

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

University of Brasilia

Brasília, Federal District, Brazil

Site Status RECRUITING

Countries

Review the countries where the study has at least one active or historical site.

Brazil

Central Contacts

Reach out to these primary contacts for questions about participation or study logistics.

Rita CM Durigan, PhD

Role: CONTACT

Phone: +55 61 3107-8450

Email: [email protected]

João LQ Durigan, PhD

Role: CONTACT

Phone: +55 61 3107-8450

Email: [email protected]

Facility Contacts

Find local site contact details for specific facilities participating in the trial.

isabella S Almeida

Role: primary

João LQ Durigan, PhD

Role: backup

References

Explore related publications, articles, or registry entries linked to this study.

Almeida IDS, Ferreira LGJ, Vaz MA, Cipriano Junior G, de Resende MA, Vieira DCL, Costa RR, Babault N, Marqueti RC, Durigan JLQ. Fatigue and neuromuscular function in long COVID: A one-year follow-up study. PLoS One. 2025 Sep 24;20(9):e0332242. doi: 10.1371/journal.pone.0332242. eCollection 2025.

Reference Type DERIVED
PMID: 40991619 (View on PubMed)

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

CAAE: 45043821.0.0000.8093

Identifier Type: -

Identifier Source: org_study_id