Using cycling with electrical stimulation to help recover from severe COVID-19

Efficacy of Physical Therapy Using Cycling With vs With no Functional Electrical Stimulation in Patient With Severe Form of COVID-19: a Randomized Controlled Trial

This study tests if using cycling with electrical stimulation can help people recovering from severe COVID-19 get stronger and improve their overall recovery.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 70 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Hospices Civils de Lyon (Academic / other)
• Locations: 1 site (Saint-Genis-Laval)
• Trial ID: NCT04841746 on ClinicalTrials.gov

What this trial studies

This study evaluates the effectiveness of functional electrical stimulation (FES) cycling as a rehabilitation method for patients recovering from severe COVID-19, particularly those who have experienced acute respiratory distress syndrome and required mechanical ventilation. Participants will undergo a standardized cycling training program, with some receiving additional functional electrical stimulation to enhance muscle recovery. The goal is to assess improvements in physical ability and overall recovery in these patients after prolonged inactivity due to their illness.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18 and older who have been hospitalized for severe COVID-19 and required intensive care with mechanical ventilation.

Not a fit: Patients requiring high levels of supplemental oxygen or those with certain neuromuscular conditions may not benefit from this study.

Why it matters

Potential benefit: If successful, this approach could significantly improve rehabilitation outcomes for patients recovering from severe COVID-19.

How similar studies have performed: While there is limited data on the specific use of FES cycling for COVID-19 recovery, similar rehabilitation approaches have shown promise in improving outcomes for patients with prolonged mechanical ventilation.

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

Where this trial is running

Saint-Genis-Laval

• Hopital Henry Gabrielle — Saint-Genis-Laval, France (Recruiting)

Study contacts

• Principal investigator: Sébastien MATEO, PT, PhD — Service Kinésithérapie
• Study coordinator: Sébastien MATEO, PT, PhD

Conditions Covid19; Ventilators, Mechanical; Respiratory Distress Syndrome; acute distress respiratory syndrome; COVID-19; mechanical ventilation