Efficiency of an Optimized Care Organization for Fatigue Management for Patients With COVID-19.

COVID-19 Clinical Trial

— CoviMouv  

Official title:

Efficiency of an Optimized Care Organization for Fatigue Management for Patients With COVID-19.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05236478
• Other study ID #: IRBN142021/CHUSTE
• Status: Completed
• Start date: February 1, 2021
• Est. completion date: July 31, 2021

Study information

• Verified date: February 2022
• Source: Centre Hospitalier Universitaire de Saint Etienne
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical 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. 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 17
• Est. completion date: July 31, 2021
• Est. primary completion date: July 31, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• 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

Exclusion Criteria:

• Patient hospitalized in intensive care >72h
• Intubated and ventilated patient in intensive care
• Non-hospitalized patient and community-based medical follow-up

Related Conditions & MeSH terms

• COVID-19
• Fatigue

Intervention

Other:
• 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.
• Control
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).

Locations

Country	Name	City	State
France	Chu Saint-Etienne	Saint-Étienne

Sponsors (1)

Lead Sponsor	Collaborator
Centre Hospitalier Universitaire de Saint Etienne

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Fatigue evaluation	assessed by Chalder Fatigue Scale (CFQ11) with score from 0 to 33. High scores represent high levels of fatigue.	At 1 Month
Secondary	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.	At 1 Month
Secondary	Aerobic performances	Assessed by the 6-minute walk test (6MWT, walking distance in meter)	At 1 Month
Secondary	Anaerobic performances	assessed by the handgrip (muscular strength of biceps in kilogram)	At 1 Month
Secondary	Physical activity	assessed by the adult physical activity questionnaire (APAQ, time spend to physical activity in hours/day)	At 1 Month
Secondary	return to work	Time needed to return to work (for active workers, time in weeks).	At 1 Month
Secondary	previous activities	Time needed to return to previous activities (for retirees, time in weeks).	At 1 Month