Covid19FESrehabCoVNCT04841746
Efficacy of FES Cycling After a Severe Form of COVID-19
A study testing Physical therapy that include a standardized cycling training with functional electrical stimulation and Physical therapy that include a standardized cycling training with no additional functional electrical stimulation in people with Covid19 and Ventilators, Mechanical, run by Hospices Civils de Lyon at 1 site in France.
Trial summary
The severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) causing the coronavirus disease 2019 (COVID-19) affect at late march 2021 more than 127 millions of persons worldwide (including more than 4.5 millions in France, according to John Hopkins University https://coronavirus.jhu.edu/map.html, consulted… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Covid19, Ventilators, Mechanical, Respiratory Distress Syndrome
- What is being tested?
- Physical therapy that include a standardized cycling training with functional electrical stimulation and Physical therapy that include a standardized cycling training with no additional functional electrical stimulation
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 22 participants
- Where
- 1 siteFrance
- Study dates
- 2 Jun 2021to 2 Oct 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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;
Show all 12Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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
The severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) causing the coronavirus disease 2019 (COVID-19) affect at late march 2021 more than 127 millions of persons worldwide (including more than 4.5 millions in France, according to John Hopkins University https://coronavirus.jhu.edu/map.html, consulted 2021/3/25). Among these persons, 17% of the confirmed cases the COVID-19 develop an acute respiratory distress syndrome (ARDS) (Chen et al., 2020), requiring an hospitalization in intensive care unit with mechanical ventilation for prolonged periods (in median up to 21 days whereas 3.3 is the usual mean length of stay). This prolonged period of inactivity causes dramatical muscles and cardio-respiratory losses. These patients experience a dramatical decrease in the physical ability which is reinforce by the protective isolation measures and containment to prevent the further spread of the virus.
Rehabilitation of patients with a severe form of the COVID-19 faced new challenges due to the novelty of the disease and protective isolation measures to prevent the further spread of the virus. Rehabilitation target a recovery of the cardio-respiratory, muscle deficits and improvement in activity. Functional electrical stimulation (FES) is one innovative technique, among other. FES have been shown as effective to improve the respiratory function in patients with a severe chronic obstructive pulmonary disease (Acheche et al., 2020; Maddocks et al., 2016), reduce the muscle loss due to zero gravity in space for astronauts (Maffiuletti et al., 2019), or increase strength in persons with incomplete spinal cord injury (de Freitas et al., 2018). FES has been recently delivered during cycling to restore pedaling movements with an adequate rhythm of muscle contraction. To date, FES cycling has been successfully administered in patients with spinal cord injury, and has been shown to be more effective in patient with severe COPD for improving the exercising intensity; reducing fatigue and improving quality of life in persons with multiple sclerosis (Backus et al., 2020).
In a pilot study, we shown that 4 week of physical therapy incluing FES cycling resulted in a fasten recovery of active postures as compared to physical therapy including cycling alone. (Mateo et al., under revision). Therefore, we hypothesize that a 4-week period of rehabilitation based on physical therapy with FES cycling would result in a significantly increase of activity profile (decrease in inactive posture duration) in patient with a severe form of COVID-19 (i.e., with an ARDS requiring mechanical ventilation).
- Being tested
- Physical therapy that include a standardized cycling training with functional electrical stimulation, Physical therapy that include a standardized cycling training with no additional functional electrical stimulation
- Keywords
- acute distress respiratory syndrome, COVID-19, mechanical ventilation
- Medical subject headings
- COVID-19, Respiratory Distress Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Physical therapy that include a standardized cycling training with functional electrical stimulationBehavioural
Immediately after the discharge of the intensive care unit, patient with a severe form of the COVID-19 will be admitted in the rehabilitation hospital. Rehabilitation will consist in physical therapy twice a day, 30 minutes, 5 days a week. One session will be dedicated to a standardized cycling training (TECHNOGYM RECLINE EXCITE 700). All participants will follow the same 4-week rehabilitation protocol representing a total of 1200 minutes. Participants randomized in the experimental group will received functional electrical stimulation administered to surface electrodes attached to lower limb muscles (quadriceps, hamstrings, gluteus maximus and triceps). Electrical stimulation will be delivered appropriately to the muscle during cycling regarding the angle of the pedal by a stimulator (Motimove-8 de 3Fit Fabricando Faber).
Physical therapy that include a standardized cycling training with no additional functional electrical stimulationBehavioural
Immediately after the discharge of the intensive care unit, patient with a severe form of the COVID-19 will be admitted in the rehabilitation hospital. Rehabilitation will consist in physical therapy twice a day, 30 minutes, 5 days a week. One session will be dedicated to a standardized cycling training (TECHNOGYM RECLINE EXCITE 700). All participants will follow the same 4-week rehabilitation protocol representing a total of 1200 minutes. Participants randomized in the control group will received no additional functional electrical stimulation during cycling.
| Study group | Role | What they receive |
|---|---|---|
| Cycling rehabilitation with functional electrical stimulation | Experimental | Not described Receives: Behavioral: Physical therapy that include a standardized cycling training with functional electrical stimulation |
| Cycling rehabilitation | Active comparator | Not described Receives: Behavioral: Physical therapy that include a standardized cycling training with no additional functional electrical stimulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in daily duration in sedentary posture between week 1 of rehabilitation (start) and week 4 of rehabilitation (end).
The duration in sedentary posture will be measured by an accelerometer (Actigraph, wGT3X, Pensacola, USA) worn at the belt on the right hip as recommended (Garnotel et al., 2018). The accelerometer is worn continously for 48 hours (i.e., from 00 to 24 hours). The Actilife ® software (current version 6) will be used to analyzed the data recorded by the accelerometer.
Measured: 48 hours (from 00 to 24 hours) during week 1 of rehabilitation (start) and week 4 of rehabilitation (end).
Secondary outcomes (15)
Daily duration in sedentary posture
The duration in sedentary posture will be measured by an accelerometer (Actigraph, wGT3X, Pensacola, USA) worn at the belt on the right hip as recommended (Garnotel et al., 2018). The accelerometer is worn continously for 48 hours (i.e., from 00 to 24 hours). The Actilife ® software (current version 6) will be used to analyzed the data recorded by the accelerometer.
Measured: 48 hours (from 00 to 24 hours) at week 1 (start), week 2, week 3, week 4 (end) of rehabilitation and 3 months after rehabilitation discharge (i.e., week 16, follow-up).
Daily duration in standing posture.
The duration in standing posture will be measured by an accelerometer (Actigraph, wGT3X, Pensacola, USA) worn at the belt on the right hip as recommended (Garnotel et al., 2018). The accelerometer is worn continously for 48 hours (i.e., from 00 to 24 hours). The Actilife ® software (current version 6) will be used to analyzed the data recorded by the accelerometer.
Measured: 48 hours (from 00 to 24 hours) at week 1 (start), week 2, week 3, week 4 (end) of rehabilitation and 3 months after rehabilitation discharge (i.e., week 16, follow-up).
Daily duration in walking/running activities.
The duration in walking/running activities will be measured by an accelerometer (Actigraph, wGT3X, Pensacola, USA) worn at the belt on the right hip as recommended (Garnotel et al., 2018). The accelerometer is worn continously for 48 hours (i.e., from 00 to 24 hours). The Actilife ® software (current version 6) will be used to analyzed the data recorded by the accelerometer.
Measured: 48 hours (from 00 to 24 hours) at week 1 (start), week 2, week 3, week 4 (end) of rehabilitation and 3 months after rehabilitation discharge (i.e., week 16, follow-up).
Daily duration in light intensity levels.
The duration in light intensity levels will be measured by an accelerometer (Actigraph, wGT3X, Pensacola, USA) worn at the belt on the right hip as recommended (Garnotel et al., 2018). The accelerometer is worn continously for 48 hours (i.e., from 00 to 24 hours). The Actilife ® software (current version 6) will be used to analyzed the data recorded by the accelerometer accordingly based on the activity counts determined by Freedson et al., (1998).
Measured: 48 hours (from 00 to 24 hours) at week 1 (start), week 2, week 3, week 4 (end) of rehabilitation and 3 months after rehabilitation discharge (i.e., week 16, follow-up).
Daily duration in moderate intensity levels.
The duration in moderate intensity levels will be measured by an accelerometer (Actigraph, wGT3X, Pensacola, USA) worn at the belt on the right hip as recommended (Garnotel et al., 2018). The accelerometer is worn continously for 48 hours (i.e., from 00 to 24 hours). The Actilife ® software (current version 6) will be used to analyzed the data recorded by the accelerometer accordingly based on the activity counts determined by Freedson et al., (1998).
Measured: 48 hours (from 00 to 24 hours) at week 1 (start), week 2, week 3, week 4 (end) of rehabilitation and 3 months after rehabilitation discharge (i.e., week 16, follow-up).
Daily duration in hard/very hard intensity levels.
This duration in hard/very hard intensity levels will be measured by an accelerometer (Actigraph, wGT3X, Pensacola, USA) worn at the belt on the right hip as recommended (Garnotel et al., 2018). The accelerometer is worn continously for 48 hours (i.e., from 00 to 24 hours). The Actilife ® software (current version 6) will be used to analyzed the data recorded by the accelerometer accordingly based on the activity counts determined by Freedson et al., (1998).
Measured: 48 hours (from 00 to 24 hours) at week 1 (start), week 2, week 3, week 4 (end) of rehabilitation and 3 months after rehabilitation discharge (i.e., week 16, follow-up).
Number of steps per day.
Number of steps per day will be measured by an accelerometer (Actigraph, wGT3X, Pensacola, USA) worn at the belt on the right hip as recommended (Garnotel et al., 2018). The accelerometer is worn continously for 48 hours (i.e., from 00 to 24 hours). The Actilife ® software (current version 6) will be used to analyzed the data recorded by the accelerometer.
Measured: 48 hours (from 00 to 24 hours) at week 1 (start), week 2, week 3, week 4 (end) of rehabilitation and 3 months after rehabilitation discharge (i.e., week 16, follow-up).
Time to complete the 10 meters walking test.
Timing the duration to complete the 10 meters distance, as fast as possible but with no running.
Measured: Test performed at the beginning of week 1 (start), week 2, week 3, week 4 (end) of rehabilitation and 3 months after rehabilitation discharge (i.e., week 16, follow-up).
Distance in meters achieved during the 6 minutes walking test.
Measured: Test performed only at 3 months after rehabilitation discharge (i.e., week 16, follow-up).
Manual muscle test of the medical research council.
Manual muscle test that assesses 3 muscle groups of the upper and lower limb (shoulder abductor, elbow flexor, wrist extensor, hip flexor, knee extensor and ankle dorsiflexor) with scores from 0 to 5. This test has been validated for patient with acquired paresis in intensive care unit (De Jonghe, 2002) and for patients with acute respiratory distress syndrome (Ciesla et al., 2011). The score range from 0 to 60 (i.e., complete paresis to normal strength).
Measured: Test performed at the beginning of week 1 (start), week 2, week 3, week 4 (end) of rehabilitation and 3 months after rehabilitation discharge (i.e., week 16, follow-up).
Forced expiratory volume in one second (FEV1).
This will be measured using a portable spirometer.
Measured: Measure performed at the beginning of week 1 (start), week 2, week 3, week 4 (end) of rehabilitation and 3 months after rehabilitation discharge (i.e., week 16, follow-up).
Forced expiratory volume (FEV).
This will be measured using a portable spirometer.
Measured: Measure performed at the beginning of week 1 (start), week 2, week 3, week 4 (end) of rehabilitation and 3 months after rehabilitation discharge (i.e., week 16, follow-up).
Skeletal muscle mass.
This will be measured using portable bioimpedancemetry with the Biody Xpert device. Data recorded will be analyzed using the Biodymanager software
Measured: Measure performed at the beginning of week 1 (start), week 2, week 3, week 4 (end) of rehabilitation and 3 months after rehabilitation discharge (i.e., week 16, follow-up).
Undernutrition blood marker.
Dosage of prealbumine and albumin will be specifically searched
Measured: Blood test performed at the beginning of week 1 (start), week 4 (end) of rehabilitation and 3 months after rehabilitation discharge (i.e., week 16, follow-up).
Muscle tonus (stiffness coefficient).
This will be measured using portable tonus device measurement Myotonpro® on quadriceps, hamstring and triceps muscles, at both lower limbs. A probe will stimulate and record the stiffness coefficient of the targeted muscles.
Measured: Measure performed at the beginning of week 1 (start), week 2, week 3, week 4 (end) of rehabilitation and 3 months after rehabilitation discharge (i.e., week 16, follow-up).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Apr 2021
- Study start2 Jun 2021
- Primary completion2 Oct 2024
- Study completion2 Oct 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Covid19Studies of the same condition, open and under way.
- More trials run by Hospices Civils de LyonThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 22 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hospices Civils de Lyon
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Sébastien MATEO, PT, PhD, Principal investigator, Service Kinésithérapie
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04841746
- Sponsor's protocol ID
- 69HCL21_0354
- Acronym
- FESrehabCoV
- Status last verified
- Dec 2025
- First submitted
- 9 Apr 2021
- Last updated
- 19 Dec 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT04841746
- Acronym / sponsor ID
- FESrehabCoV / 69HCL21_0354
- Keywords
- acute distress respiratory syndrome, COVID-19, mechanical ventilation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 22 participants (actual)
- Lead sponsor
- Hospices Civils de LyonUniversity, hospital or other
- Study start
- 2 Jun 2021 (actual)
- Primary completion
- 2 Oct 2024 (actual)
- Study completion
- 2 Oct 2024 (actual)
- First posted
- 12 Apr 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) causing the coronavirus disease 2019 (COVID-19) affect at late march 2021 more than 127 millions of persons worldwide (including more than 4.5 millions in France, according to John Hopkins University https://coronavirus.jhu.edu/map.html, consulted 2021/3/25). Among these persons, 17% of the confirmed cases the COVID-19 develop an acute respiratory distress syndrome (ARDS) (Chen et al., 2020), requiring an hospitalization in intensive care unit with mechanical ventilation for prolonged periods (in median up to 21 days whereas 3.3 is the usual mean length of stay). This prolonged period of inactivity causes dramatical muscles and cardio-respiratory losses. These patients experience a dramatical decrease in the physical ability which is reinforce by the protective isolation measures and containment to prevent the further spread of the virus.
Rehabilitation of patients with a severe form of the COVID-19 faced new challenges due to the novelty of the disease and protective isolation measures to prevent the further spread of the virus. Rehabilitation target a recovery of the cardio-respiratory, muscle deficits and improvement in activity. Functional electrical stimulation (FES) is one innovative technique, among other. FES have been shown as effective to improve the respiratory function in patients with a severe chronic obstructive pulmonary disease (Acheche et al., 2020; Maddocks et al., 2016), reduce the muscle loss due to zero gravity in space for astronauts (Maffiuletti et al., 2019), or increase strength in persons with incomplete spinal cord injury (de Freitas et al., 2018). FES has been recently delivered during cycling to restore pedaling movements with an adequate rhythm of muscle contraction. To date, FES cycling has been successfully administered in patients with spinal cord injury, and has been shown to be more effective in patient with severe COPD for improving the exercising intensity; reducing fatigue and improving quality of life in persons with multiple sclerosis (Backus et al., 2020).
In a pilot study, we shown that 4 week of physical therapy incluing FES cycling resulted in a fasten recovery of active postures as compared to physical therapy including cycling alone. (Mateo et al., under revision). Therefore, we hypothesize that a 4-week period of rehabilitation based on physical therapy with FES cycling would result in a significantly increase of activity profile (decrease in inactive posture duration) in patient with a severe form of COVID-19 (i.e., with an ARDS requiring mechanical ventilation).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Cycling rehabilitation with functional electrical stimulation | Experimental | Behavioral: Physical therapy that include a standardized cycling training with functional electrical stimulation |
| Cycling rehabilitation | Active comparator | Behavioral: Physical therapy that include a standardized cycling training with no additional functional electrical stimulation |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (12 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Physical therapy that include a standardized cycling training with functional electrical stimulationImmediately after the discharge of the intensive care unit, patient with a severe form of the COVID-19 will be admitted in the rehabilitation hospital. Rehabilitation will consist in physical therapy twice a day, 30 minutes, 5 days a week. One session will be dedicated to a standardized cycling training (TECHNOGYM RECLINE EXCITE 700). All participants will follow the same 4-week rehabilitation protocol representing a total of 1200 minutes. Participants randomized in the experimental group will received functional electrical stimulation administered to surface electrodes attached to lower limb muscles (quadriceps, hamstrings, gluteus maximus and triceps). Electrical stimulation will be delivered appropriately to the muscle during cycling regarding the angle of the pedal by a stimulator (Motimove-8 de 3Fit Fabricando Faber). | Behavioural | Cycling rehabilitation with functional electrical stimulation |
| Physical therapy that include a standardized cycling training with no additional functional electrical stimulationImmediately after the discharge of the intensive care unit, patient with a severe form of the COVID-19 will be admitted in the rehabilitation hospital. Rehabilitation will consist in physical therapy twice a day, 30 minutes, 5 days a week. One session will be dedicated to a standardized cycling training (TECHNOGYM RECLINE EXCITE 700). All participants will follow the same 4-week rehabilitation protocol representing a total of 1200 minutes. Participants randomized in the control group will received no additional functional electrical stimulation during cycling. | Behavioural | Cycling rehabilitation |
Primary outcome
Change in daily duration in sedentary posture between week 1 of rehabilitation (start) and week 4 of rehabilitation (end).
Time frame: 48 hours (from 00 to 24 hours) during week 1 of rehabilitation (start) and week 4 of rehabilitation (end).
The duration in sedentary posture will be measured by an accelerometer (Actigraph, wGT3X, Pensacola, USA) worn at the belt on the right hip as recommended (Garnotel et al., 2018). The accelerometer is worn continously for 48 hours (i.e., from 00 to 24 hours). The Actilife ® software (current version 6) will be used to analyzed the data recorded by the accelerometer.
15 secondary outcomes
Daily duration in sedentary posture
Time frame: 48 hours (from 00 to 24 hours) at week 1 (start), week 2, week 3, week 4 (end) of rehabilitation and 3 months after rehabilitation discharge (i.e., week 16, follow-up).
Daily duration in standing posture.
Time frame: 48 hours (from 00 to 24 hours) at week 1 (start), week 2, week 3, week 4 (end) of rehabilitation and 3 months after rehabilitation discharge (i.e., week 16, follow-up).
Daily duration in walking/running activities.
Time frame: 48 hours (from 00 to 24 hours) at week 1 (start), week 2, week 3, week 4 (end) of rehabilitation and 3 months after rehabilitation discharge (i.e., week 16, follow-up).
Daily duration in light intensity levels.
Time frame: 48 hours (from 00 to 24 hours) at week 1 (start), week 2, week 3, week 4 (end) of rehabilitation and 3 months after rehabilitation discharge (i.e., week 16, follow-up).
Daily duration in moderate intensity levels.
Time frame: 48 hours (from 00 to 24 hours) at week 1 (start), week 2, week 3, week 4 (end) of rehabilitation and 3 months after rehabilitation discharge (i.e., week 16, follow-up).
Daily duration in hard/very hard intensity levels.
Time frame: 48 hours (from 00 to 24 hours) at week 1 (start), week 2, week 3, week 4 (end) of rehabilitation and 3 months after rehabilitation discharge (i.e., week 16, follow-up).
Number of steps per day.
Time frame: 48 hours (from 00 to 24 hours) at week 1 (start), week 2, week 3, week 4 (end) of rehabilitation and 3 months after rehabilitation discharge (i.e., week 16, follow-up).
Time to complete the 10 meters walking test.
Time frame: Test performed at the beginning of week 1 (start), week 2, week 3, week 4 (end) of rehabilitation and 3 months after rehabilitation discharge (i.e., week 16, follow-up).
Distance in meters achieved during the 6 minutes walking test.
Time frame: Test performed only at 3 months after rehabilitation discharge (i.e., week 16, follow-up).
Manual muscle test of the medical research council.
Time frame: Test performed at the beginning of week 1 (start), week 2, week 3, week 4 (end) of rehabilitation and 3 months after rehabilitation discharge (i.e., week 16, follow-up).
Forced expiratory volume in one second (FEV1).
Time frame: Measure performed at the beginning of week 1 (start), week 2, week 3, week 4 (end) of rehabilitation and 3 months after rehabilitation discharge (i.e., week 16, follow-up).
Forced expiratory volume (FEV).
Time frame: Measure performed at the beginning of week 1 (start), week 2, week 3, week 4 (end) of rehabilitation and 3 months after rehabilitation discharge (i.e., week 16, follow-up).
Skeletal muscle mass.
Time frame: Measure performed at the beginning of week 1 (start), week 2, week 3, week 4 (end) of rehabilitation and 3 months after rehabilitation discharge (i.e., week 16, follow-up).
Undernutrition blood marker.
Time frame: Blood test performed at the beginning of week 1 (start), week 4 (end) of rehabilitation and 3 months after rehabilitation discharge (i.e., week 16, follow-up).
Muscle tonus (stiffness coefficient).
Time frame: Measure performed at the beginning of week 1 (start), week 2, week 3, week 4 (end) of rehabilitation and 3 months after rehabilitation discharge (i.e., week 16, follow-up).
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Dec 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Sébastien MATEO, PT, PhD principal investigator
Service Kinésithérapie
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Physical therapy that include a standardized cycling training with functional electrical stimulation and Physical therapy that include a standardized cycling training with no additional functional electrical stimulation in people with Covid19 and Ventilators, Mechanical, run by Hospices Civils de Lyon at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 19 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in daily duration in sedentary posture between week 1 of rehabilitation (start) and week 4 of rehabilitation (end). (time frame: 48 hours (from 00 to 24 hours) during week 1 of rehabilitation (start) and week 4 of rehabilitation (end).). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Dec 2025.