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

Sponsor
Centre Hospitalier Universitaire de Saint Etienne (Other)
Overall Status
Completed
CT.gov ID
NCT05236478
Collaborator
(none)
17
1
5.9
2.9

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Other: CoviMouv' program
  • Other: Control

Study Design

Study Type:
Observational
Actual Enrollment :
17 participants
Observational Model:
Case-Control
Time Perspective:
Prospective
Official Title:
Efficiency of an Optimized Care Organization for Fatigue Management for Patients With COVID-19.
Actual Study Start Date :
Feb 1, 2021
Actual Primary Completion Date :
Jul 31, 2021
Actual Study Completion Date :
Jul 31, 2021

Arms and Interventions

Arm 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).

Outcome Measures

Primary Outcome Measures

  1. 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

  1. 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.

  2. Aerobic performances [At 1 Month]

    Assessed by the 6-minute walk test (6MWT, walking distance in meter)

  3. Anaerobic performances [At 1 Month]

    assessed by the handgrip (muscular strength of biceps in kilogram)

  4. Physical activity [At 1 Month]

    assessed by the adult physical activity questionnaire (APAQ, time spend to physical activity in hours/day)

  5. return to work [At 1 Month]

    Time needed to return to work (for active workers, time in weeks).

  6. previous activities [At 1 Month]

    Time needed to return to previous activities (for retirees, time in weeks).

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Chu Saint-Etienne Saint-Étienne France

Sponsors and Collaborators

  • Centre Hospitalier Universitaire de Saint Etienne

Investigators

  • Principal Investigator: David HUPIN, MD, CHU SAINT-ETIENNE

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Centre Hospitalier Universitaire de Saint Etienne
ClinicalTrials.gov Identifier:
NCT05236478
Other Study ID Numbers:
  • IRBN142021/CHUSTE
First Posted:
Feb 11, 2022
Last Update Posted:
Mar 2, 2022
Last Verified:
Feb 1, 2022
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Centre Hospitalier Universitaire de Saint Etienne
Additional relevant MeSH terms:

Study Results

No Results Posted as of Mar 2, 2022