5 Years Quality of Life and Early Mobilization in ICU

NCT ID: NCT05527678

Last Updated: 2023-05-17

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Total Enrollment

138 participants

Study Classification

OBSERVATIONAL

Study Start Date

2022-10-28

Study Completion Date

2023-05-02

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

In a study published in 2018 the research team had collected the Medical Research Council score (MRCs) at Intensive Care Unit (ICU) discharge.

The investigators would like to be able to examine, if the preliminary results obtained by in 2020 by Van Aerde's team are confirmed in their cohort.

The investigators hypothesize that patients with an MRCs less than or equal to 55 at discharge from the ICU, have a higher mortality rate than those with a score greater than 55.

The investigators would also like to examine whether or not an MRCs score ≤ 55 is associated with a difference in quality of life and autonomy, after 5 and more years post ICU.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Study design Prospective, observational study.

1. Research of vital status
2. Completion of two questionnaires (Short Form-36 and Katz Index of Independence in Activities of Daily Living), to assess quality of life and level of autonomy in activities of daily living, either by telephone or completed directly by hand by the patient from his place of residence.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Quality of Life ICU Acquired Weakness Morality

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

5 years ICU survivors

Survivors 5 years after ICU and who participated in the Promorea1 study will be contacted to assess their quality of life.

Questionnaires

Intervention Type OTHER

Written or by phone

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Questionnaires

Written or by phone

Intervention Type OTHER

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* Have participated in the Promorea1 study
* Alive at the time the questionnaires were sent

Exclusion Criteria

* Opposition to the use of vital status data
* Extra-national patient not on the national registry
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Centre Hospitalier Régional d'Orléans

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Guillaume FOSSAT, Pt Msc

Role: PRINCIPAL_INVESTIGATOR

Centre Hospitalier Régional d'Orléans

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Centre Hospitalier Régional d'Orléans

Orléans, Centre-Val de Loire, France

Site Status

Countries

Review the countries where the study has at least one active or historical site.

France

References

Explore related publications, articles, or registry entries linked to this study.

Ware JE Jr, Sherbourne CD. The MOS 36-item short-form health survey (SF-36). I. Conceptual framework and item selection. Med Care. 1992 Jun;30(6):473-83.

Reference Type RESULT
PMID: 1593914 (View on PubMed)

Fossat G, Baudin F, Courtes L, Bobet S, Dupont A, Bretagnol A, Benzekri-Lefevre D, Kamel T, Muller G, Bercault N, Barbier F, Runge I, Nay MA, Skarzynski M, Mathonnet A, Boulain T. Effect of In-Bed Leg Cycling and Electrical Stimulation of the Quadriceps on Global Muscle Strength in Critically Ill Adults: A Randomized Clinical Trial. JAMA. 2018 Jul 24;320(4):368-378. doi: 10.1001/jama.2018.9592.

Reference Type RESULT
PMID: 30043066 (View on PubMed)

Van Aerde N, Meersseman P, Debaveye Y, Wilmer A, Gunst J, Casaer MP, Bruyninckx F, Wouters PJ, Gosselink R, Van den Berghe G, Hermans G. Five-year impact of ICU-acquired neuromuscular complications: a prospective, observational study. Intensive Care Med. 2020 Jun;46(6):1184-1193. doi: 10.1007/s00134-020-05927-5. Epub 2020 Jan 22.

Reference Type RESULT
PMID: 31970446 (View on PubMed)

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

CHRO-2022-02

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

MICU Recovery Clinic
NCT02560129 COMPLETED