COVIDRECOVER-19NCT04466800

Functional and Respiratory Rehabilitation and Nutritional Care of COVID-19 Patients (RECOVER-19)

A study testing Intervention group_rehabilitation program in people with COVID, run by Rennes University Hospital at 5 sites in France.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

Search all trials

Trial summary

Following the acute phase of COVID, some patients may have sequelae, such as breathing difficulties or malnutrition. We hypothesize that a functional and respiratory rehabilitation program associated with personalized nutritional care will improve quality of life, physical performance and respiratory capacities and… Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: COVID
What is being tested?: Intervention group_rehabilitation program
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 160 participants
Where: 5 sitesFrance
Study dates: 30 Jul 2020to 13 Jan 2023
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 above 18 years
Laboratory (RT-PCR and/or serology) confirmed infection with SARS-CoV-2
Date of first symptoms of SARS-CoV-2 infection > 4 weeks and < 4 months
Persisting functional and/or respiratory deficit and/or asthenia and/or malnutrition beyond the first 4 weeks after COVID, defined as :
Increase of mMRC (Modified Medical Research Council) score ≥ 1 between the month before COVID and beyond the first 4 weeks after COVID and/or
Asthenia score (Pichot asthenia scale) > 22 beyond the first 4 weeks after COVID, if patient had no asthenia before COVID (asthenia score <8) and/or

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Weight loss > 5% within 6 months, comparing minimum weight between the month before COVID and beyond the first 4 weeks after COVID and/or
BMI (Body Mass Index) < 20 (if age < 70 years) or < 22 (if age ≥ 70 years) if BMI (Body Mass Index) ≥ 20 (if age < 70 years) or ≥ 22 (if age ≥ 70 years) the month before COVID
Patient affiliated to social security system
Patient gave written informed consent

Who cannot join

Patient unable to undergo a rehabilitation program due to comorbidities, such as major cardio-vascular disease or severe dementia
Patient currently benefiting from physiotherapy sessions, in particular motor and / or respiratory therapy and / or an exercise re-training and / or respiratory rehabilitation program
Patient living in a residential facility for dependent elderly people
Patient not speaking french
Pregnant women

Trial locations and contacts

5 sites in 1 country.

City, postcode or hospital

5 sites in 1 country

France5 sites

Hôtel Dieu Paris
Paris
Centre Hospitalier de Cornouaille
Quimper
CHU Rennes
Rennes
Centre Hospitalier de Saint-Brieuc
Saint-Brieuc
Centre Hospitalier Bretagne Atlantique
Vannes

Other trials in France

About this study

Official title: Functional and Respiratory Rehabilitation and Nutritional Care of COVID-19 Patients

Read the detailed description

In France, more than 150 000 patients have been infected by the SARS-CoV-2 virus and COVID has been responsible for more than 100 000 hospitalizations. Following the acute phase of this disease, some patients may have sequelae, such as breathing difficulties or malnutrition. However, the prevalence and intensity of those sequelae still remain unknown. Thus, a functional and respiratory rehabilitation program associated with personalized nutritional care may be necessary to improve those patients' prognosis.

This study aims to evaluate the effectiveness of a 4-week rehabilitation program following the acute phase of COVID. This program includes regular physical activity supervised by a physical acticity educator, a systematic malnutrition screening and a nutritional follow-up performed by a dietitian. Patients will be randomized in two groups: rehabilitation program (intervention group) or usual care (control group). Quality of life, physical performance, respiratory capacities and nutritional status will be assessed in both groups at inclusion and one month later (corresponding to the end of the rehabilitation program for the intervention group).

Conditions: COVID
Being tested: Intervention group_rehabilitation program
Keywords: COVID, Rehabilitation, Adapted physical activity, Malnutrition
Medical subject headings: Malnutrition

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Intervention group_rehabilitation programOther
Regular physical activity, supervised by a physical education educator, a systematic malnutrition screening and a nutritional follow-up performed by a dietetician.
Patients will follow a 4-week rehabilitation program, comprising 3 physical activity sessions per week for 4 weeks. First sessions will be supervised by a physical activity educator and patients will perform the following sessions at home, using physical training software. The physical activity educator will call patients once a week to ensure the sessions are correctly performed and adapt the program if necessary. Patients will also undergo a nutritional assessment carried out by a dietitian at the beginning of the program. A dietitian will call patients once a week to ensure their nutritional status is appropriate.

Study groups in NCT04466800
Study group	Role	What they receive
Intervention group_rehabilitation program	Experimental	multidisciplinary and personalized rehabilitation program Receives: Other: Intervention group_rehabilitation program
Control group	No intervention	Usual care of each site, including delivery of an information sheet concerning recommended physical activity (based on WHO recommendations) and nutrition. One month after inclusion, patients of this group will be offered a rehabilitation program (as described in the intervention group, but with only one session with a physical activity educator at home) and one dietitian consultation.

What is being measured

The primary outcome is the main question the study is designed to answer.

Impact of a multidisciplinary and personalized rehabilitation program on COVID patients's quality of life
Physical component score of the Short-Form 36 health survey between the beginning and the end of the rehabilitation program (from 0 to 100; highers scores mean better outcome)
Measured: 1 month

Secondary outcomes (47)

Impact of a multidisciplinary and personalized rehabilitation program in terms of Physical capacities
Number of repeated chair rises during 3 minutes
Measured: 1 month
Impact of a multidisciplinary and personalized rehabilitation program in terms of Physical capacities
Aerobic physical capacity using Eval-DM software
Measured: 1 month
Impact of a multidisciplinary and personalized rehabilitation program in terms of Respiratory capacities
Modified Medical Research Council scale (mMRC) (from 0 to 4, highers scores mean worse outcome)
Measured: 1 month
Impact of a multidisciplinary and personalized rehabilitation program in terms of Respiratory capacities
Modified Medical Research Council scale (mMRC) (from 0 to 4, highers scores mean worse outcome)
Measured: 3 months
Impact of a multidisciplinary and personalized rehabilitation program in terms of Respiratory capacities
Modified Medical Research Council scale (mMRC) (from 0 to 4, highers scores mean worse outcome)
Measured: 6 months
Impact of a multidisciplinary and personalized rehabilitation program in terms of Respiratory capacities
Borg scale (from 0 to 10, highers scores mean worse outcome)
Measured: 1 month
Impact of a multidisciplinary and personalized rehabilitation program in terms of Functional capacities
Barthel scale (from 0 to 100, highers scores mean worse outcome)
Measured: 1 month
Impact of a multidisciplinary and personalized rehabilitation program in terms of Functional capacities
Barthel scale (from 0 to 100, highers scores mean worse outcome)
Measured: 3 months
Impact of a multidisciplinary and personalized rehabilitation program in terms of Functional capacities
Barthel scale (from 0 to 100, highers scores mean worse outcome)
Measured: 6 months
Impact of a multidisciplinary and personalized rehabilitation program in terms of Malnutrition prevalence rate using GLIM malnutrition diagnostic criteria
Weight loss
Measured: 1 month
Impact of a multidisciplinary and personalized rehabilitation program in terms of Malnutrition prevalence rate using GLIM malnutrition diagnostic criteria
Weight loss
Measured: 3 months
Impact of a multidisciplinary and personalized rehabilitation program in terms of Malnutrition prevalence rate using GLIM malnutrition diagnostic criteria
Weight loss
Measured: 6 months
Impact of a multidisciplinary and personalized rehabilitation program in terms of Malnutrition prevalence rate using GLIM malnutrition diagnostic criteria
Body mass index
Measured: 1 month
Impact of a multidisciplinary and personalized rehabilitation program in terms of Malnutrition prevalence rate using GLIM malnutrition diagnostic criteria
Body mass index
Measured: 3 months
Impact of a multidisciplinary and personalized rehabilitation program in terms of Malnutrition prevalence rate using GLIM malnutrition diagnostic criteria
Body mass index
Measured: 6 months
Impact of a multidisciplinary and personalized rehabilitation program in terms of Malnutrition prevalence rate using GLIM malnutrition diagnostic criteria
Muscular mass by brachial circumference or grip strength
Measured: 1 month
Impact of a multidisciplinary and personalized rehabilitation program in terms of Malnutrition prevalence rate using GLIM malnutrition diagnostic criteria
SEFI® score (from 0 to 10, highers scores mean better outcome)
Measured: 1 month
Impact of a multidisciplinary and personalized rehabilitation program in terms of Malnutrition prevalence rate using GLIM malnutrition diagnostic criteria
SEFI® score (from 0 to 10, highers scores mean better outcome)
Measured: 3 months
Impact of a multidisciplinary and personalized rehabilitation program in terms of Malnutrition prevalence rate using GLIM malnutrition diagnostic criteria
SEFI® score (from 0 to 10, highers scores mean better outcome)
Measured: 6 months
Impact of a multidisciplinary and personalized rehabilitation program in terms of mortality
Mortality rate
Measured: 1 month
Impact of a multidisciplinary and personalized rehabilitation program in terms of mortality
Mortality rate
Measured: 3 months
Impact of a multidisciplinary and personalized rehabilitation program in terms of mortality
Mortality rate
Measured: 6 months
Impact of a multidisciplinary and personalized rehabilitation program in terms of Quality of life
Score of the Short-Form 36 health Survey (from 0 to 100, highers scores mean better outcome)
Measured: 1 month
Impact of a multidisciplinary and personalized rehabilitation program in terms of Quality of life
Score of the Short-Form 36 health Survey (from 0 to 100, highers scores mean better outcome)
Measured: 3 months
Impact of a multidisciplinary and personalized rehabilitation program in terms of Quality of life
Score of the Short-Form 36 health Survey (from 0 to 100, highers scores mean better outcome)
Measured: 6 months
Impact of a multidisciplinary and personalized rehabilitation program in terms of Quality of life
EuroQol 5 Dimensions 5 Levels surveys (from 0 to 1, highers scores mean better outcome)
Measured: 1 month
Impact of a multidisciplinary and personalized rehabilitation program in terms of Quality of life
EuroQol 5 Dimensions 5 Levels surveys (from 0 to 1, highers scores mean better outcome)
Measured: 3 months
Impact of a multidisciplinary and personalized rehabilitation program in terms of Quality of life
EuroQol 5 Dimensions 5 Levels surveys (from 0 to 1, highers scores mean better outcome)
Measured: 6 months
Impact of a multidisciplinary and personalized rehabilitation program in terms of Quality of life
Proportion of patients returning to a professional activity
Measured: 1 month
Impact of a multidisciplinary and personalized rehabilitation program in terms of Quality of life
Proportion of patients returning to a professional activity
Measured: 3 months
Impact of a multidisciplinary and personalized rehabilitation program in terms of Quality of life
Proportion of patients returning to a professional activity
Measured: 6 months
Impact of a multidisciplinary and personalized rehabilitation program in terms of Anxiety and depression
Hospital and Anxiety Depression Scale (from 0 to 42, highers scores mean worse outcome)
Measured: 1 month
Impact of a multidisciplinary and personalized rehabilitation program in terms of Anxiety and depression
Hospital and Anxiety Depression Scale (from 0 to 42, highers scores mean worse outcome
Measured: 3 months
Impact of a multidisciplinary and personalized rehabilitation program in terms of Anxiety and depression
Hospital and Anxiety Depression Scale (from 0 to 42, highers scores mean worse outcome
Measured: 6 months
Impact of a multidisciplinary and personalized rehabilitation program in terms of Anxiety and depression
Pichot asthenia scale (from 0 to 32, highers mean worse outcome)
Measured: 1 month
Impact of a multidisciplinary and personalized rehabilitation program in terms of Anxiety and depression
Pichot asthenia scale (from 0 to 32, highers mean worse outcome)
Measured: 3 months
Impact of a multidisciplinary and personalized rehabilitation program in terms of Anxiety and depression
Pichot asthenia scale (from 0 to 32, highers mean worse outcome)
Measured: 6 months
Impact of a multidisciplinary and personalized rehabilitation program in terms of Healthcare consumption
Number of consultations with the healthcare professionals
Measured: 1 month
Impact of a multidisciplinary and personalized rehabilitation program in terms of Healthcare consumption
Number of consultations with the healthcare professionals
Measured: 3 months
Impact of a multidisciplinary and personalized rehabilitation program in terms of Healthcare consumption
Number of consultations with the healthcare professionals
Measured: 6 months
Impact of a multidisciplinary and personalized rehabilitation program in terms of Healthcare consumption
Rehospitalisation rate (all causes)
Measured: 1 month
Impact of a multidisciplinary and personalized rehabilitation program in terms of Healthcare consumption
Rehospitalisation rate (all causes)
Measured: 3 months
Impact of a multidisciplinary and personalized rehabilitation program in terms of Healthcare consumption
Rehospitalisation rate (all causes)
Measured: 6 months
Impact of a multidisciplinary and personalized rehabilitation program in terms of Medico-economic evaluation
Incremental cost-effectiveness ratio
Measured: 3 months
Impact of a multidisciplinary and personalized rehabilitation program in terms of Medico-economic evaluation
Incremental cost-effectiveness ratio
Measured: 6 months
Patient's opinion concerning the rehabilitation program
Satisfaction questionnaire with open-ended questions (no specific scale is available)
Measured: 3 months
Patient's opinion concerning the rehabilitation program
Satisfaction questionnaire with open-ended questions (no specific scale is available)
Measured: 6 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

30 Jul 202013 Jan 2023

First posted10 Jul 2020
Study start30 Jul 2020
Primary completion29 Aug 2022
Study completion13 Jan 2023

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for COVIDStudies of the same condition, open and under way.
More trials run by Rennes University HospitalThe 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: Supportive care
Allocation: Randomised
Intervention model: Parallel groups
Model description: Multicenter, randomized, comparative, parallel-group trial
Masking: None (open label)
Enrolment: 160 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT04466800
Sponsor's protocol ID: 35RC20_9875_RECOVER-19
Acronym: RECOVER-19
Status last verified: Jan 2023
First submitted: 9 Jul 2020
Last updated: 26 Jan 2023
Results posted: No
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All COVID trials

Study at a glance

From the registry record, last updated by the sponsor on 26 Jan 2023. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Functional and Respiratory Rehabilitation and Nutritional Care of COVID-19 Patients
ClinicalTrials.gov ID: NCT04466800
Acronym / sponsor ID: RECOVER-19 / 35RC20_9875_RECOVER-19
Conditions: COVID
Keywords: COVID, Rehabilitation, Adapted physical activity, Malnutrition
Study type: Interventional
Recruitment status: Completed
Enrolment: 160 participants (actual)
Lead sponsor: Rennes University HospitalUniversity, hospital or other
Study start: 30 Jul 2020 (actual)
Primary completion: 29 Aug 2022 (actual)
Study completion: 13 Jan 2023 (actual)
First posted: 10 Jul 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.

Detailed description

Study design

Primary purpose: Supportive care
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 2
Model description: Multicenter, randomized, comparative, parallel-group trial

Arm	Type	Receives
Intervention group_rehabilitation program	Experimental	Other: Intervention group_rehabilitation programmultidisciplinary and personalized rehabilitation program
Control group	No intervention	–Usual care of each site, including delivery of an information sheet concerning recommended physical activity (based on WHO recommendations) and nutrition. One month after inclusion, patients of this group will be offered a rehabilitation program (as described in the intervention group, but with only one session with a physical activity educator at home) and one dietitian consultation.

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (10 listed)

Age above 18 years
Laboratory (RT-PCR and/or serology) confirmed infection with SARS-CoV-2
Date of first symptoms of SARS-CoV-2 infection > 4 weeks and < 4 months
Persisting functional and/or respiratory deficit and/or asthenia and/or malnutrition beyond the first 4 weeks after COVID, defined as :
Increase of mMRC (Modified Medical Research Council) score ≥ 1 between the month before COVID and beyond the first 4 weeks after COVID and/or

Key exclusion criteria (5 listed)

Patient unable to undergo a rehabilitation program due to comorbidities, such as major cardio-vascular disease or severe dementia
Patient currently benefiting from physiotherapy sessions, in particular motor and / or respiratory therapy and / or an exercise re-training and / or respiratory rehabilitation program
Patient living in a residential facility for dependent elderly people
Patient not speaking french
Pregnant women

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
Intervention group_rehabilitation programRegular physical activity, supervised by a physical education educator, a systematic malnutrition screening and a nutritional follow-up performed by a dietetician. Patients will follow a 4-week rehabilitation program, comprising 3 physical activity sessions per week for 4 weeks. First sessions will be supervised by a physical activity educator and patients will perform the following sessions at home, using physical training software. The physical activity educator will call patients once a week to ensure the sessions are correctly performed and adapt the program if necessary. Patients will also undergo a nutritional assessment carried out by a dietitian at the beginning of the program. A dietitian will call patients once a week to ensure their nutritional status is appropriate.	Other	Intervention group_rehabilitation program

Primary outcome

Impact of a multidisciplinary and personalized rehabilitation program on COVID patients's quality of life
Time frame: 1 month
Physical component score of the Short-Form 36 health survey between the beginning and the end of the rehabilitation program (from 0 to 100; highers scores mean better outcome)

47 secondary outcomes

Impact of a multidisciplinary and personalized rehabilitation program in terms of Physical capacities
Time frame: 1 month
Impact of a multidisciplinary and personalized rehabilitation program in terms of Physical capacities
Time frame: 1 month
Impact of a multidisciplinary and personalized rehabilitation program in terms of Respiratory capacities
Time frame: 1 month
Impact of a multidisciplinary and personalized rehabilitation program in terms of Respiratory capacities
Time frame: 3 months
Impact of a multidisciplinary and personalized rehabilitation program in terms of Respiratory capacities
Time frame: 6 months
Impact of a multidisciplinary and personalized rehabilitation program in terms of Respiratory capacities
Time frame: 1 month
Impact of a multidisciplinary and personalized rehabilitation program in terms of Functional capacities
Time frame: 1 month
Impact of a multidisciplinary and personalized rehabilitation program in terms of Functional capacities
Time frame: 3 months
Impact of a multidisciplinary and personalized rehabilitation program in terms of Functional capacities
Time frame: 6 months
Impact of a multidisciplinary and personalized rehabilitation program in terms of Malnutrition prevalence rate using GLIM malnutrition diagnostic criteria
Time frame: 1 month
Impact of a multidisciplinary and personalized rehabilitation program in terms of Malnutrition prevalence rate using GLIM malnutrition diagnostic criteria
Time frame: 3 months
Impact of a multidisciplinary and personalized rehabilitation program in terms of Malnutrition prevalence rate using GLIM malnutrition diagnostic criteria
Time frame: 6 months
Impact of a multidisciplinary and personalized rehabilitation program in terms of Malnutrition prevalence rate using GLIM malnutrition diagnostic criteria
Time frame: 1 month
Impact of a multidisciplinary and personalized rehabilitation program in terms of Malnutrition prevalence rate using GLIM malnutrition diagnostic criteria
Time frame: 3 months
Impact of a multidisciplinary and personalized rehabilitation program in terms of Malnutrition prevalence rate using GLIM malnutrition diagnostic criteria
Time frame: 6 months
Impact of a multidisciplinary and personalized rehabilitation program in terms of Malnutrition prevalence rate using GLIM malnutrition diagnostic criteria
Time frame: 1 month
Impact of a multidisciplinary and personalized rehabilitation program in terms of Malnutrition prevalence rate using GLIM malnutrition diagnostic criteria
Time frame: 1 month
Impact of a multidisciplinary and personalized rehabilitation program in terms of Malnutrition prevalence rate using GLIM malnutrition diagnostic criteria
Time frame: 3 months
Impact of a multidisciplinary and personalized rehabilitation program in terms of Malnutrition prevalence rate using GLIM malnutrition diagnostic criteria
Time frame: 6 months
Impact of a multidisciplinary and personalized rehabilitation program in terms of mortality
Time frame: 1 month
Impact of a multidisciplinary and personalized rehabilitation program in terms of mortality
Time frame: 3 months
Impact of a multidisciplinary and personalized rehabilitation program in terms of mortality
Time frame: 6 months
Impact of a multidisciplinary and personalized rehabilitation program in terms of Quality of life
Time frame: 1 month
Impact of a multidisciplinary and personalized rehabilitation program in terms of Quality of life
Time frame: 3 months
Impact of a multidisciplinary and personalized rehabilitation program in terms of Quality of life
Time frame: 6 months
Impact of a multidisciplinary and personalized rehabilitation program in terms of Quality of life
Time frame: 1 month
Impact of a multidisciplinary and personalized rehabilitation program in terms of Quality of life
Time frame: 3 months
Impact of a multidisciplinary and personalized rehabilitation program in terms of Quality of life
Time frame: 6 months
Impact of a multidisciplinary and personalized rehabilitation program in terms of Quality of life
Time frame: 1 month
Impact of a multidisciplinary and personalized rehabilitation program in terms of Quality of life
Time frame: 3 months
Impact of a multidisciplinary and personalized rehabilitation program in terms of Quality of life
Time frame: 6 months
Impact of a multidisciplinary and personalized rehabilitation program in terms of Anxiety and depression
Time frame: 1 month
Impact of a multidisciplinary and personalized rehabilitation program in terms of Anxiety and depression
Time frame: 3 months
Impact of a multidisciplinary and personalized rehabilitation program in terms of Anxiety and depression
Time frame: 6 months
Impact of a multidisciplinary and personalized rehabilitation program in terms of Anxiety and depression
Time frame: 1 month
Impact of a multidisciplinary and personalized rehabilitation program in terms of Anxiety and depression
Time frame: 3 months
Impact of a multidisciplinary and personalized rehabilitation program in terms of Anxiety and depression
Time frame: 6 months
Impact of a multidisciplinary and personalized rehabilitation program in terms of Healthcare consumption
Time frame: 1 month
Impact of a multidisciplinary and personalized rehabilitation program in terms of Healthcare consumption
Time frame: 3 months
Impact of a multidisciplinary and personalized rehabilitation program in terms of Healthcare consumption
Time frame: 6 months

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 26 Jan 2023.
Individual participant dataSharing planned: No

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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.

Lilian Alix, Dr principal investigator

Rennes University Hospital

Aranzazu PEDROSA GONZALEZ, Dr principal investigator

Centre Hospitalier de Saint-Brieuc

Christophe POPINEAU, Dr principal investigator

Centre Hospitalier Bretagne Atlantique

5 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing Intervention group_rehabilitation program in people with COVID, run by Rennes University Hospital at 5 sites 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 10 inclusion and 5 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 26 Jan 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 5 sites 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?

Impact of a multidisciplinary and personalized rehabilitation program on COVID patients's quality of life (time frame: 1 month). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04466800.

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 26 Jan 2023.