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

NCT ID: NCT05236478

Last Updated: 2022-03-02

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 17 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2021-02-01
• Study Completion Date: 2021-07-31

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.

Conditions

COVID-19; Fatigue

Study Design

• Observational Model Type: CASE_CONTROL
• Study Time Perspective: PROSPECTIVE

Study Groups

CoviMouv' program

Patients who have benefited from the CoviMouv' program (supervised physical activity program + therapeutic education program) will be included.

CoviMouv' program

Intervention Type: OTHER

• 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).

Control

Intervention Type: OTHER

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).

Interventions

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.

Intervention Type: 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).

Intervention Type: OTHER

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Centre Hospitalier Universitaire de Saint Etienne

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

David HUPIN, MD

Role: PRINCIPAL_INVESTIGATOR

CHU SAINT-ETIENNE

Locations

Chu Saint-Etienne

Saint-Etienne, , France

Countries

France

Other Identifiers

IRBN142021/CHUSTE

Identifier Type: -

Identifier Source: org_study_id