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Completed

NCT Number: NCT05236478

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

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.

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Key information

Conditions

COVID-19 Behavior Coronaviridae Infections Coronavirus Infections Fatigue Infections Lung Diseases Motor Activity Nidovirales Infections Pathological Conditions, Signs and Symptoms Pneumonia Pneumonia, Viral RNA Virus Infections Respiratory Tract Diseases Respiratory Tract Infections Signs and Symptoms Virus Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Chu Saint-Etienne

Saint-Etienne, France

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

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).

Primary outcomes

  1. Fatigue evaluation

    Time frame: At 1 Month

    assessed by Chalder Fatigue Scale (CFQ11) with score from 0 to 33. High scores represent high levels of fatigue.

Secondary outcomes

  1. Quality of life (MOS-SF 12)

    Time frame: 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

    Time frame: At 1 Month

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

  3. Anaerobic performances

    Time frame: At 1 Month

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

  4. Physical activity

    Time frame: At 1 Month

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

  5. return to work

    Time frame: At 1 Month

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

  6. previous activities

    Time frame: At 1 Month

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

Sponsors and collaborators

Lead sponsor

Centre Hospitalier Universitaire de Saint Etienne

Other

Registry information

Acronym: CoviMouv

Important dates

Study start
2021
Primary completion
2021
Study completion
2021
First posted
Feb 11, 2022
Registry last updated
Mar 2, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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