Sars-CoV2PHYSIO-COVIDNCT04347070
Implementation of Physiotherapy on COVID-19 Patients in ICU
An observational study of Sars-CoV2 and COVID-19, run by University Hospital, Montpellier at 1 site in France.
Trial summary
Despite new charachersitics of COVID-19 patients, critical care implementation seems to be similar to those with Acute Respiratory Distress Syndrome (ARDS) in intensive care units (ICU). Read more about this study
- Who is it for?
- Ages 18 years and older
- What is being tested?
- Phsyiotherapy
- How many people
- 150 participants
- Where
- 1 siteFrance
- Study dates
- 1 Apr 2017to 1 Dec 2022
- Phase
- Observational
- 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
Study population: Patients admitted in ICU with COVID-19 will be eligible
Who may be able to join
- Age > 18 years
- Patient admitted in ICU
- Patient with COVID-19 diagnosis
Who cannot join
- Explicite denie to participate in the study
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Implementation of Physiotherapy on COVID-19 Patients in Intensive Care Units : a Retrospective, Multicentric, International Study
Despite new charachersitics of COVID-19 patients, critical care implementation seems to be similar to those with Acute Respiratory Distress Syndrome (ARDS) in intensive care units (ICU).
Regarding the initial gravity of these patients, sedation and neuromuscular blockers are usually administrated, increasing the risk to develope an ICU-acquired weakness which is directly correlated to morbi-mortality and a burden during recovery.
Read more
Respiratory symptoms are mostly related to dyspnoea and non-productive cough, with only 33% of COVID-19 patient having a bronchial hypersecretion ; consequently, chest physiotherapy is only implemented in after case-by-case evaluation.
This unprecedented situation requires to identify how physiotherapy is being implemented in COVID-19 patients in ICU.
This retrospective, multicentric study aims to identify the charactheristics of physiotherapy (type and time spent) implemented in Argentina, Belgium, Chili, France, Italy and Spain
Read the detailed description
- Demographics data : hospitalisation date, ICU date, COVID+ date, extubation date, discharge date, mortality
- ICU data : ventilatory mode, type of physiotherapy implemented (early rehabilitation, chest physiotherapy, time spent (minutes), number of interventions per day.
- Being tested
- Phsyiotherapy
- Keywords
- COVID-19, Physiotherapy, implementation, critical care
- Medical subject headings
- COVID-19
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PhsyiotherapyOther
To observe if patients with COVID-19 benefice of physiothersapy, which kind and how many time
| Study group | Role | What they receive |
|---|---|---|
| Patients accepted in ICU diagnosed with COVID-19 | Patients accepted in ICU diagnosed with COVID-19 Receives: Other: Phsyiotherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time of physiotherapy
Time of physiotherapy (minutes)
Measured: 1 day
Time of physiotherapy
Time of physiotherapy (minutes)
Measured: 3 day
Time of physiotherapy
Time of physiotherapy (minutes)
Measured: 7 day
Secondary outcomes (3)
Type of physiotherapy implemented
Type of physiotherapy , early rehabilitation or chest phsyitoherapy
Measured: 1 day
Type of physiotherapy implemented
Type of physiotherapy , early rehabilitation or chest phsyitoherapy
Measured: 3 day
Type of physiotherapy implemented
Type of physiotherapy , early rehabilitation or chest phsyitoherapy
Measured: 7 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Apr 2020
- Study start1 Apr 2017
- Primary completion1 Sep 2020
- Study completion1 Dec 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Sars-CoV2Studies of the same condition, open and under way.
- More trials run by University Hospital, MontpellierThe 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
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 150 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Montpellier
- Sponsor type
- University, hospital or other
- Collaborators
- Société espagnole de pneumologie (SEPAR), Societe française de kinésithérapie en réanimation (SKR)
- Responsible party
- Sponsor
- Investigators
- Roberto Martinez-Alejos, MD, PhD, Study director, University Hospital, Montpellier
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04347070
- Sponsor's protocol ID
- RECHMPL20_0175
- Acronym
- PHYSIO-COVID
- Status last verified
- Dec 2020
- First submitted
- 10 Apr 2020
- Last updated
- 29 Dec 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: NC
Study at a glance
From the registry record, last updated by the sponsor on 29 Dec 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Implementation of Physiotherapy on COVID-19 Patients in Intensive Care Units : a Retrospective, Multicentric, International Study
- ClinicalTrials.gov ID
- NCT04347070
- Acronym / sponsor ID
- PHYSIO-COVID / RECHMPL20_0175
- Keywords
- COVID-19, Physiotherapy, implementation, critical care
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 150 participants (actual)
- Lead sponsor
- University Hospital, MontpellierUniversity, hospital or other
- Collaborators
- Société espagnole de pneumologie (SEPAR), Societe française de kinésithérapie en réanimation (SKR)
- Study start
- 1 Apr 2017 (actual)
- Primary completion
- 1 Sep 2020 (actual)
- Study completion
- 1 Dec 2022 (estimated)
- First posted
- 15 Apr 2020 (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.
Despite new charachersitics of COVID-19 patients, critical care implementation seems to be similar to those with Acute Respiratory Distress Syndrome (ARDS) in intensive care units (ICU).
Regarding the initial gravity of these patients, sedation and neuromuscular blockers are usually administrated, increasing the risk to develope an ICU-acquired weakness which is directly correlated to morbi-mortality and a burden during recovery.
Respiratory symptoms are mostly related to dyspnoea and non-productive cough, with only 33% of COVID-19 patient having a bronchial hypersecretion ; consequently, chest physiotherapy is only implemented in after case-by-case evaluation.
This unprecedented situation requires to identify how physiotherapy is being implemented in COVID-19 patients in ICU.
This retrospective, multicentric study aims to identify the charactheristics of physiotherapy (type and time spent) implemented in Argentina, Belgium, Chili, France, Italy and Spain
Detailed description
- Demographics data : hospitalisation date, ICU date, COVID+ date, extubation date, discharge date, mortality
- ICU data : ventilatory mode, type of physiotherapy implemented (early rehabilitation, chest physiotherapy, time spent (minutes), number of interventions per day.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients accepted in ICU diagnosed with COVID-19 | – | Other: PhsyiotherapyPatients accepted in ICU diagnosed with COVID-19 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients admitted in ICU with COVID-19 will be eligible
Key inclusion criteria (3 listed)
- Age > 18 years
- Patient admitted in ICU
- Patient with COVID-19 diagnosis
Key exclusion criteria (1 listed)
- Explicite denie to participate in the study
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 |
|---|---|---|
| PhsyiotherapyTo observe if patients with COVID-19 benefice of physiothersapy, which kind and how many time | Other | Patients accepted in ICU diagnosed with COVID-19 |
Primary outcome
Time of physiotherapy
Time frame: 1 day
Time of physiotherapy (minutes)
Time of physiotherapy
Time frame: 3 day
Time of physiotherapy (minutes)
Time of physiotherapy
Time frame: 7 day
Time of physiotherapy (minutes)
3 secondary outcomes
Type of physiotherapy implemented
Time frame: 1 day
Type of physiotherapy implemented
Time frame: 3 day
Type of physiotherapy implemented
Time frame: 7 day
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Dec 2020.
- Individual participant dataSharing planned: Undecided. NC
Related trials for Sars-CoV2
Not yet recruitingPhase 1
Phase I Open-Label Safety Trial of Pembrolizumab for Neurological Post- Acute Sequelae of SARS-CoV-2 (PD1-PASC I)
Post-Acute COVID-19 Syndrome
Active, not recruitingPhase 1
A Safety and Immunogenicity Trial of OCU500, ChAd36 Vector Encoding SARS-CoV-2 Spike Vaccine Via Intranasal and Inhalational Routes in Previously Vaccinated Adults
COVID-19
Enrolling by invitation
Personalized Ventilator Settings for Patients on ECMO
Acute Respiratory Distress Syndrome (ARDS), Extracorporeal Membrane Oxygenation
Recruiting
Home-Based Exercise Tele-Rehabilitation After COVID-19
Post SARS-CoV2 (COVID-19)
Not yet recruitingPhase 1
A Safety, Reactogenicity and Immunogenicity Trial of RVX-sCPD9 Booster Intranasal COVID-19 Vaccine
COVID -19
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.
Roberto Martinez-Alejos, MD, PhD study director
University Hospital, Montpellier
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Sars-CoV2 and COVID-19, run by University Hospital, Montpellier 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 1 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: status not confirmed, as of the sponsor's last update on 29 Dec 2020. 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?
Results are not available in the source record.
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?
Time of physiotherapy (time frame: 1 day). The study lists 3 primary outcomes in all. 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 29 Dec 2020.