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

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 Overview

• Status: Completed
• Conditions: COVID-19; Fatigue
• Intervention / Treatment: Other: CoviMouv' program; Other: Control

• Study Type: Observational
• Enrollment (Actual): 17

Contacts and Locations

Study Locations

• France
  • Saint-Étienne, France
    • CHU Saint-Etienne

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Acute fatigue post-COVID-19

Description

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 Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
CoviMouv' program; Patients who have benefited from the CoviMouv' program (supervised physical activity program + therapeutic education program) will be included.	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 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).	Other: 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).

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
Aerobic performances	Assessed by the 6-minute walk test (6MWT, walking distance in meter)	At 1 Month
Anaerobic performances	assessed by the handgrip (muscular strength of biceps in kilogram)	At 1 Month
Physical activity	assessed by the adult physical activity questionnaire (APAQ, time spend to physical activity in hours/day)	At 1 Month
return to work	Time needed to return to work (for active workers, time in weeks).	At 1 Month
previous activities	Time needed to return to previous activities (for retirees, time in weeks).	At 1 Month

Collaborators and Investigators

• Sponsor: Centre Hospitalier Universitaire de Saint Etienne

Study record dates

Study Major Dates

• Study Start (Actual): February 1, 2021
• Primary Completion (Actual): July 31, 2021
• Study Completion (Actual): July 31, 2021

Study Registration Dates

• First Submitted: February 10, 2022
• First Submitted That Met QC Criteria: February 10, 2022
• First Posted (Actual): February 11, 2022

Study Record Updates

• Last Update Posted (Actual): March 2, 2022
• Last Update Submitted That Met QC Criteria: February 11, 2022
• Last Verified: February 1, 2022

More Information

Terms related to this study

• Keywords: physical activity; Fatigue; COVID-19; training; therapeutic education
• Additional Relevant MeSH Terms: Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Virus Diseases; Infections; Respiratory Tract Infections; Respiratory Tract Diseases; Pneumonia, Viral; Pneumonia; Lung Diseases; COVID-19; Fatigue
• Other Study ID Numbers: IRBN142021/CHUSTE

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No