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

Completed

• Conditions: COVID-19; Fatigue
• Interventions: Other: Control; Other: CoviMouv' program

• Registration Number: NCT05236478
• Lead Sponsor: Centre Hospitalier Universitaire de Saint Etienne

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2021-02-01
• Primary Completion: 2021-07-31
• Study Completion: 2021-07-31
• Status Verified: 2022-02
• Study First Submitted: 2022-02-10
• Study First Submitted QC: 2022-02-10
• Study First Posted: 2022-02-11
• Last Update Submitted: 2022-02-11
• Last Update Posted: 2022-03-02

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 17

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
control group	Control	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).
CoviMouv' program	CoviMouv' program	Patients who have benefited from the CoviMouv' program (supervised physical activity program + therapeutic education program) will be included.

Primary Outcome Measures

Name	Time	Method
Fatigue evaluation	At 1 Month	assessed by Chalder Fatigue Scale (CFQ11) with score from 0 to 33. High scores represent high levels of fatigue.

Secondary Outcome Measures

Name	Time	Method
Anaerobic performances	At 1 Month	assessed by the handgrip (muscular strength of biceps in kilogram)
Quality of life (MOS-SF 12)	At 1 Month	assessed by the medical outcome study short form questionnaire (MOS-SF 12, score from 0 to 100). High scores represent high patient's ability.
Aerobic performances	At 1 Month	Assessed by the 6-minute walk test (6MWT, walking distance in meter)
Physical activity	At 1 Month	assessed by the adult physical activity questionnaire (APAQ, time spend to physical activity in hours/day)
return to work	At 1 Month	Time needed to return to work (for active workers, time in weeks).
previous activities	At 1 Month	Time needed to return to previous activities (for retirees, time in weeks).

Trial Locations

Locations (1)

Chu Saint-Etienne; 🇫🇷 Saint-Étienne, France