COVID-19CoviMouvNCT05236478
Efficiency of an Optimized Care Organization for Fatigue Management for Patients With COVID-19.
An observational study of COVID-19 and Fatigue, run by Centre Hospitalier Universitaire de Saint Etienne at 1 site in France.
Trial summary
Length of hospitalization for COVID-19 infection may be increased due to the persistence of fatigue in 29-46% of cases. Its management is essential to prevent the chronic fatigue . Chronic fatigue syndrome affected between 30 and 40% of patients with SARS in 2003 or MERS in 2005 and persisted beyond 3 years. Read more about this study
- Who is it for?
- Ages 18 years and older
- What is being tested?
- CoviMouv' program
- How many people
- 17 participants
- Where
- 1 siteFrance
- Study dates
- 1 Feb 2021to 31 Jul 2021
- 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: Acute fatigue post-COVID-19
Who may be able to join
- Patient living in the Loire region, France
- Patient showing post COVID-19 fatigue (RT PCR positive <1 month)
- Non-intubated patient if hospitalization in intensive care (<72h)
- Patient hospitalized in a Covid unit at the Saint Etienne Hospital
Who cannot join
- Patient hospitalized in intensive care >72h
- Intubated and ventilated patient in intensive care
- Non-hospitalized patient and community-based medical follow-up
Trial locations and contacts
1 site in 1 country.
About this study
Length of hospitalization for COVID-19 infection may be increased due to the persistence of fatigue in 29-46% of cases. Its management is essential to prevent the chronic fatigue . Chronic fatigue syndrome affected between 30 and 40% of patients with SARS in 2003 or MERS in 2005 and persisted beyond 3 years. There is currently no specific treatment for acute or <4 months asthenia. To avoid the transition to chronicity, some authors recommend respecting a long rest period. However, a program combining adapted physical activity and therapeutic patient education has already shown significant benefits for combating recent or semi-recent fatigue following a cardiovascular pathology and even during cancer treatments. Therefore, the existing care pathway for hospitalized patients with COVID-19 was adapted, combining exercise training and therapeutic patient education workshops.
- Being tested
- CoviMouv' program, Control
- Keywords
- COVID-19, Fatigue, training, therapeutic education, physical activity
- Medical subject headings
- COVID-19, Fatigue, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CoviMouv' programOther
- An initiation to physical rehabilitation at the hospital center the first week, 3 sessions of 1 hour.
- A tele-rehabilitation program led by an Adapted Physical Activity (APA) teacher for 3 weeks with 3 sessions of 1 hour per week.
All the sessions are led by a professional of adapted physical activity and will be personalized and adapted to the functional tests carried out during the initial evaluation.
- Therapeutic education video-workshops weekly: about (i) the pathophysiology of fatigue in COVID-19, (ii) returning to work, (iii) lifestyle: sleep, physical activity and diet.
- The medical follow-up will be carried out remotely with 1 weekly teleconsultation with a physiologist.
- Psychological and / or dietetic follow-up, if necessary, during the program: 1 weekly teleconsultation At the end of the program, each participant is invited to contact the sport-health platform in order to continue the Adapted Physical Activity (APA) practice near home for 2 months.
ControlOther
The CoviMouv' program is not presented to theses patients They have support for the resumption of an adapted physical activity in autonomy, according to the results of the aerobic and anaerobic tests carried out during the initial evaluation (delivery of a training booklet).
| Study group | Role | What they receive |
|---|---|---|
| CoviMouv' program | Patients who have benefited from the CoviMouv' program (supervised physical activity program + therapeutic education program) will be included. Receives: Other: CoviMouv' program | |
| control group | Patients with autonomous physical activity at home or with a community-based physiotherapist will be included. They will have support for the resumption of an adapted physical activity in autonomy, according to the results of the aerobic and anaerobic tests carried out during the initial evaluation (delivery of a training booklet). Receives: Other: Control |
What is being measured
The primary outcome is the main question the study is designed to answer.
Fatigue evaluation
assessed by Chalder Fatigue Scale (CFQ11) with score from 0 to 33. High scores represent high levels of fatigue.
Measured: At 1 Month
Secondary outcomes (6)
Quality of life (MOS-SF 12)
assessed by the medical outcome study short form questionnaire (MOS-SF 12, score from 0 to 100). High scores represent high patient's ability.
Measured: At 1 Month
Aerobic performances
Assessed by the 6-minute walk test (6MWT, walking distance in meter)
Measured: At 1 Month
Anaerobic performances
assessed by the handgrip (muscular strength of biceps in kilogram)
Measured: At 1 Month
Physical activity
assessed by the adult physical activity questionnaire (APAQ, time spend to physical activity in hours/day)
Measured: At 1 Month
return to work
Time needed to return to work (for active workers, time in weeks).
Measured: At 1 Month
previous activities
Time needed to return to previous activities (for retirees, time in weeks).
Measured: At 1 Month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Feb 2022
- Study start1 Feb 2021
- Primary completion31 Jul 2021
- Study completion31 Jul 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for COVID-19Studies of the same condition, open and under way.
- More trials run by Centre Hospitalier Universitaire de Saint EtienneThe 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
- Case-control
- Time perspective
- Prospective
- Enrolment
- 17 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- David HUPIN, MD, Principal investigator, Centre Hospitalier Universitaire de Saint Etienne
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05236478
- Sponsor's protocol ID
- IRBN142021/CHUSTE
- Acronym
- CoviMouv
- Status last verified
- Feb 2022
- First submitted
- 10 Feb 2022
- Last updated
- 2 Mar 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Mar 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficiency of an Optimized Care Organization for Fatigue Management for Patients With COVID-19.
- ClinicalTrials.gov ID
- NCT05236478
- Acronym / sponsor ID
- CoviMouv / IRBN142021/CHUSTE
- Keywords
- COVID-19, Fatigue, training, therapeutic education, physical activity
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 17 participants (actual)
- Lead sponsor
- Centre Hospitalier Universitaire de Saint EtienneUniversity, hospital or other
- Study start
- 1 Feb 2021 (actual)
- Primary completion
- 31 Jul 2021 (actual)
- Study completion
- 31 Jul 2021 (actual)
- First posted
- 11 Feb 2022 (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.
Length of hospitalization for COVID-19 infection may be increased due to the persistence of fatigue in 29-46% of cases. Its management is essential to prevent the chronic fatigue . Chronic fatigue syndrome affected between 30 and 40% of patients with SARS in 2003 or MERS in 2005 and persisted beyond 3 years. There is currently no specific treatment for acute or <4 months asthenia. To avoid the transition to chronicity, some authors recommend respecting a long rest period. However, a program combining adapted physical activity and therapeutic patient education has already shown significant benefits for combating recent or semi-recent fatigue following a cardiovascular pathology and even during cancer treatments. Therefore, the existing care pathway for hospitalized patients with COVID-19 was adapted, combining exercise training and therapeutic patient education workshops.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| CoviMouv' program | – | Other: CoviMouv' programPatients who have benefited from the CoviMouv' program (supervised physical activity program + therapeutic education program) will be included. |
| control group | – | Other: ControlPatients with autonomous physical activity at home or with a community-based physiotherapist will be included. They will have support for the resumption of an adapted physical activity in autonomy, according to the results of the aerobic and anaerobic tests carried out during the initial evaluation (delivery of a training booklet). |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Acute fatigue post-COVID-19
Key inclusion criteria (4 listed)
- Patient living in the Loire region, France
- Patient showing post COVID-19 fatigue (RT PCR positive <1 month)
- Non-intubated patient if hospitalization in intensive care (<72h)
- Patient hospitalized in a Covid unit at the Saint Etienne Hospital
Key exclusion criteria (3 listed)
- Patient hospitalized in intensive care >72h
- Intubated and ventilated patient in intensive care
- Non-hospitalized patient and community-based medical follow-up
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 |
|---|---|---|
| CoviMouv' program* An initiation to physical rehabilitation at the hospital center the first week, 3 sessions of 1 hour. * A tele-rehabilitation program led by an Adapted Physical Activity (APA) teacher for 3 weeks with 3 sessions of 1 hour per week. All the sessions are led by a professional of adapted physical activity and will be personalized and adapted to the functional tests carried out during the initial evaluation. * Therapeutic education video-workshops weekly: about (i) the pathophysiology of fatigue in COVID-19, (ii) returning to work, (iii) lifestyle: sleep, physical activity and diet. * The medical follow-up will be carried out remotely with 1 weekly teleconsultation with a physiologist. * Psychological and / or dietetic follow-up, if necessary, during the program: 1 weekly teleconsultation At the end of the program, each participant is invited to contact the sport-health platform in order to continue the Adapted Physical Activity (APA) practice near home for 2 months. | Other | CoviMouv' program |
| ControlThe CoviMouv' program is not presented to theses patients They have support for the resumption of an adapted physical activity in autonomy, according to the results of the aerobic and anaerobic tests carried out during the initial evaluation (delivery of a training booklet). | Other | control group |
Primary outcome
Fatigue evaluation
Time frame: At 1 Month
assessed by Chalder Fatigue Scale (CFQ11) with score from 0 to 33. High scores represent high levels of fatigue.
6 secondary outcomes
Quality of life (MOS-SF 12)
Time frame: At 1 Month
Aerobic performances
Time frame: At 1 Month
Anaerobic performances
Time frame: At 1 Month
Physical activity
Time frame: At 1 Month
return to work
Time frame: At 1 Month
previous activities
Time frame: At 1 Month
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 2 Mar 2022.
- Individual participant dataSharing planned: No
Related trials for COVID-19
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
Active, not recruiting
Intervention to Address Disparate Mental Health Consequences of COVID-19 Pandemic on Latinx and African Newcomers
Mental Health Issue, Mental Health Disorder
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.
David HUPIN, MD principal investigator
Centre Hospitalier Universitaire de Saint Etienne
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 COVID-19 and Fatigue, run by Centre Hospitalier Universitaire de Saint Etienne 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 4 inclusion and 3 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 2 Mar 2022. 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?
Fatigue evaluation (time frame: At 1 Month). 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 2 Mar 2022.