NCT04466800

Brief Summary

Following the acute phase of COVID, some patients may have sequelae, such as breathing difficulties or malnutrition. We hypothesize that a functional and respiratory rehabilitation program associated with personalized nutritional care will improve quality of life, physical performance and respiratory capacities and will decrease the prevalence of malnutrition among those patients.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
160

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jul 2020

Typical duration for not_applicable

Geographic Reach
1 country

5 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 9, 2020

Completed
1 day until next milestone

First Posted

Study publicly available on registry

July 10, 2020

Completed
20 days until next milestone

Study Start

First participant enrolled

July 30, 2020

Completed
2.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 29, 2022

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

January 13, 2023

Completed
Last Updated

January 26, 2023

Status Verified

January 1, 2023

Enrollment Period

2.1 years

First QC Date

July 9, 2020

Last Update Submit

January 25, 2023

Conditions

COVID

Keywords

COVIDRehabilitationAdapted physical activityMalnutrition

Outcome Measures

Primary Outcomes (1)

  • Impact of a multidisciplinary and personalized rehabilitation program on COVID patients's quality of life

    Physical component score of the Short-Form 36 health survey between the beginning and the end of the rehabilitation program (from 0 to 100; highers scores mean better outcome)

    1 month

Secondary Outcomes (47)

  • Impact of a multidisciplinary and personalized rehabilitation program in terms of Physical capacities

    1 month

  • Impact of a multidisciplinary and personalized rehabilitation program in terms of Physical capacities

    1 month

  • Impact of a multidisciplinary and personalized rehabilitation program in terms of Respiratory capacities

    1 month

  • Impact of a multidisciplinary and personalized rehabilitation program in terms of Respiratory capacities

    3 months

  • Impact of a multidisciplinary and personalized rehabilitation program in terms of Respiratory capacities

    6 months

  • +42 more secondary outcomes

Study Arms (2)

Intervention group_rehabilitation program

EXPERIMENTAL

multidisciplinary and personalized rehabilitation program

Other: Intervention group_rehabilitation program

Control group

NO INTERVENTION

Usual care of each site, including delivery of an information sheet concerning recommended physical activity (based on WHO recommendations) and nutrition. One month after inclusion, patients of this group will be offered a rehabilitation program (as described in the intervention group, but with only one session with a physical activity educator at home) and one dietitian consultation.

Interventions

Intervention group_rehabilitation programOTHER

Regular physical activity, supervised by a physical education educator, a systematic malnutrition screening and a nutritional follow-up performed by a dietetician. Patients will follow a 4-week rehabilitation program, comprising 3 physical activity sessions per week for 4 weeks. First sessions will be supervised by a physical activity educator and patients will perform the following sessions at home, using physical training software. The physical activity educator will call patients once a week to ensure the sessions are correctly performed and adapt the program if necessary. Patients will also undergo a nutritional assessment carried out by a dietitian at the beginning of the program. A dietitian will call patients once a week to ensure their nutritional status is appropriate.

Intervention group_rehabilitation program

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Age above 18 years
  • Laboratory (RT-PCR and/or serology) confirmed infection with SARS-CoV-2
  • Date of first symptoms of SARS-CoV-2 infection \> 4 weeks and \< 4 months
  • Persisting functional and/or respiratory deficit and/or asthenia and/or malnutrition beyond the first 4 weeks after COVID, defined as :
  • Increase of mMRC (Modified Medical Research Council) score ≥ 1 between the month before COVID and beyond the first 4 weeks after COVID and/or
  • Asthenia score (Pichot asthenia scale) \> 22 beyond the first 4 weeks after COVID, if patient had no asthenia before COVID (asthenia score \<8) and/or
  • Weight loss \> 5% within 6 months, comparing minimum weight between the month before COVID and beyond the first 4 weeks after COVID and/or
  • BMI (Body Mass Index) \< 20 (if age \< 70 years) or \< 22 (if age ≥ 70 years) if BMI (Body Mass Index) ≥ 20 (if age \< 70 years) or ≥ 22 (if age ≥ 70 years) the month before COVID
  • Patient affiliated to social security system
  • Patient gave written informed consent

You may not qualify if:

  • Patient unable to undergo a rehabilitation program due to comorbidities, such as major cardio-vascular disease or severe dementia
  • Patient currently benefiting from physiotherapy sessions, in particular motor and / or respiratory therapy and / or an exercise re-training and / or respiratory rehabilitation program
  • Patient living in a residential facility for dependent elderly people
  • Patient not speaking french
  • Pregnant women

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (5)

Hôtel Dieu Paris

Paris, France

Location

Centre Hospitalier de Cornouaille

Quimper, France

Location

CHU Rennes

Rennes, France

Location

Centre Hospitalier de Saint-Brieuc

Saint-Brieuc, France

Location

Centre Hospitalier Bretagne Atlantique

Vannes, France

Location

MeSH Terms

Conditions

Malnutrition

Condition Hierarchy (Ancestors)

Nutrition DisordersNutritional and Metabolic Diseases

Study Officials

  • Lilian Alix, Dr

    Rennes University Hospital

    PRINCIPAL INVESTIGATOR

  • Aranzazu PEDROSA GONZALEZ, Dr

    Centre Hospitalier de Saint-Brieuc

    PRINCIPAL INVESTIGATOR

  • Christophe POPINEAU, Dr

    Centre Hospitalier Bretagne Atlantique

    PRINCIPAL INVESTIGATOR

  • Patricia THOREUX, Pr

    Hôtel Dieu Paris

    PRINCIPAL INVESTIGATOR

  • Nadia SAIDANI, Dr

    Centre Hospitalier de Cornouaille

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Model Details: Multicenter, randomized, comparative, parallel-group trial
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 9, 2020

First Posted

July 10, 2020

Study Start

July 30, 2020

Primary Completion

August 29, 2022

Study Completion

January 13, 2023

Last Updated

January 26, 2023

Record last verified: 2023-01

Data Sharing

IPD Sharing
Will not share

Locations

FR(5)