Efficacy of FES Cycling After a Severe Form of COVID-19
Launched by HOSPICES CIVILS DE LYON · Apr 9, 2021
Trial Information
Current as of June 26, 2025
Recruiting
Keywords
ClinConnect Summary
This clinical trial is studying the effectiveness of a rehabilitation technique called Functional Electrical Stimulation (FES) cycling for patients recovering from severe COVID-19. Many patients with severe COVID-19 experience serious breathing difficulties that require them to be on a ventilator in the hospital. This can lead to significant loss of muscle strength and physical ability due to being inactive for long periods. The trial aims to see if a 4-week program that includes FES cycling can help these patients regain their strength and improve their ability to move around more actively.
To participate in this trial, individuals must be at least 18 years old and have been hospitalized for a severe form of COVID-19 that required intensive care and mechanical ventilation. However, some people may not be eligible, such as those who need a high level of oxygen support or have certain medical conditions that could complicate the rehabilitation process. Participants can expect a focused rehabilitation program designed to improve their physical abilities, and they will be closely monitored throughout the trial to ensure their safety and progress.
Gender
ALL
Eligibility criteria
- Inclusion Criteria:
- • Age ≥ 18 years
- • Being hospitalized for rehabilitation because of a severe form of the COVID-19 that required an admission in intensive care unit for acute distress respiratory syndrome treated by mechanical ventilation.
- • Being beneficiary of the French social security.
- Exclusion Criteria:
- • Person requiring supplementation in oxygen \> 4 L/min because above this threshold, the oxygen flow is considered to be associated with an increased risk of aerosolization and further virus spread in patient being contagious;
- • Oxygen desaturation during exercise (i.e., SpO2 \< 90%) and requiring supplementation in oxygen \> 4 L/min.
- • Person showing a lower motor neuron disease as defined by the medical research council score \< 48/60 including hyporeflexia (quadricipital and triceps tendons) and decrease in lower limb sensation.
- • Persons showing denervated muscle (including quadriceps, hamstring, gluteus and triceps) confirmed by electromyography because the electrical stimulations delivered by the stimulator (i.e., symmetric and rectangular biphasic currents) are not appropriate to restore a pedaling movement;
- • Person with osteo-articular disease at lower limbs including reduction in range of motion at the hip, knee and ankle preventing cycling pedaling in a sitting position;
- • Persons with associated neurologic or psychiatric disease;
- • Person with a medical contraindication to intensive rehabilitation;
- • Person suffering from suspected or diagnosed epilepsy;
- • Person with an implanted device;
- • Person included in another ongoing research or during an exclusion period of another research;
- • Adults protected by law (guardianship or curatorship);
- • Pregnant women
About Hospices Civils De Lyon
Hospices Civils de Lyon (HCL) is a leading public health institution in France, dedicated to providing high-quality healthcare and advancing medical research. With a rich history dating back to the 18th century, HCL encompasses multiple hospitals and offers a diverse range of services across various medical specialties. The institution is committed to fostering innovative clinical trials that aim to enhance patient care and improve therapeutic outcomes. By collaborating with academic and industry partners, HCL plays a pivotal role in the development of new treatments and the advancement of medical knowledge, ensuring that research efforts are aligned with the highest ethical standards and patient safety protocols.
Contacts
Jennifer Cobb
Immunology at National Institute of Allergy and Infectious Diseases (NIAID)
Locations
Saint Genis Laval, , France
Patients applied
Trial Officials
Sébastien MATEO, PT, PhD
Principal Investigator
Service Kinésithérapie
Timeline
First submit
Trial launched
Trial updated
Estimated completion
Not reported
Similar Trials