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

NCT05236478 | Completed

• 1 other identifier: IRBN142021/CHUSTE
• Study Type: observational
• Target: 17
• Locations: 1 country
• Sites: 1

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

Keywords

COVID-19; Fatigue; training; therapeutic education; physical activity

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (6)

• Quality of life (MOS-SF 12)

  At 1 Month

• Aerobic performances

  At 1 Month

• Anaerobic performances

  At 1 Month

• Physical activity

  At 1 Month

• return to work

  At 1 Month

Study Arms (2)

CoviMouv' program

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

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).

Other: Control

Interventions

CoviMouv' program 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.

CoviMouv' program

Control 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).

control group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Acute fatigue post-COVID-19

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• Centre Hospitalier Universitaire de Saint Etienne: lead

Study Sites (1)

Chu Saint-Etienne

Saint-Etienne, France

Location

MeSH Terms

Conditions

COVID-19; Fatigue; Motor Activity

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Behavior

Study Officials

• David HUPIN, MD

  CHU SAINT-ETIENNE

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 10, 2022
• First Posted: February 11, 2022
• Study Start: February 1, 2021
• Primary Completion: July 31, 2021
• Study Completion: July 31, 2021
• Last Updated: March 2, 2022

Record last verified: 2022-02

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)