NCT04503486

Brief Summary

The aim is to study the impact of muscle strength measured in ICU and after ICU discharge on health-related quality of life measured after hospital discharge.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
100

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Aug 2020

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
unknown

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 1, 2020

Completed
Same day until next milestone

Study Start

First participant enrolled

August 1, 2020

Completed
6 days until next milestone

First Posted

Study publicly available on registry

August 7, 2020

Completed
2.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 31, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 31, 2022

Completed
Last Updated

August 11, 2020

Status Verified

August 1, 2020

Enrollment Period

2.1 years

First QC Date

August 1, 2020

Last Update Submit

August 9, 2020

Conditions

Critical IllnessMuscle StrengthQuadriceps StrengthGrip StrengthQuality of Life

Outcome Measures

Primary Outcomes (6)

  • health-related quality of life

    assessed using the Sarcopenia Quality of Life (SARQOL) questionnaire short form: 8 questions with qualitative responses

    1 month after ICU discharge

  • health-related quality of life

    assessed using the Sarcopenia Quality of Life (SARQOL) questionnaire short form: 8 questions with qualitative responses

    3 months after ICU discharge

  • health-related quality of life

    assessed using the Sarcopenia Quality of Life (SARQOL) questionnaire short form: 8 questions with qualitative responses

    6 months after ICU discharge

  • health-related quality of life

    assessed using the EuroQOL 5 dimensions (EQ-5D) questionnaire: a first part assess the 5 dimensions of health state (each dimension is scored from 1 to 3, 3 indicating extreme problems). A second part is visual analog scale ranging from 0 (the worst health you can imagine) to 100 (the best health you can imagine)

    1 month after ICU discharge

  • health-related quality of life

    assessed using the EuroQOL 5 dimensions (EQ-5D) questionnaire: a first part assess the 5 dimensions of health state (each dimension is scored from 1 to 3, 3 indicating extreme problems). A second part is visual analog scale ranging from 0 (the worst health you can imagine) to 100 (the best health you can imagine)

    3 months after ICU discharge

  • health-related quality of life

    assessed using the EuroQOL 5 dimensions (EQ-5D) questionnaire: a first part assess the 5 dimensions of health state (each dimension is scored from 1 to 3, 3 indicating extreme problems). A second part is visual analog scale ranging from 0 (the worst health you can imagine) to 100 (the best health you can imagine)

    6 months after ICU discharge

Interventions

handgrip strengthDIAGNOSTIC_TEST

measure of handgrip strength using Jamar Dynamometer and a standardized protocol, strength expressed in kg

quadriceps strengthDIAGNOSTIC_TEST

maximal isometric quadriceps strength measured using a handheld dynamometer and a standardized protocol, strength expressed in Newton

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

the study includes patients in ICU after a stay of at least 7 days. They are included as soon as they are collaborative.

You may qualify if:

  • critically ill patients with an ICU stay of at least 7 days
  • collaborative

You may not qualify if:

  • non collaborative, confusion, coma
  • limb paresis or plegia
  • patient refusal

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University Hospital of Liège

Liège, 4000, Belgium

RECRUITING

MeSH Terms

Conditions

Critical Illness

Condition Hierarchy (Ancestors)

Disease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Central Study Contacts

Anne-Françoise Rousseau, MD, PhD

CONTACT

+3243667495afrousseau@chuliege.be

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
head of clinic

Study Record Dates

First Submitted

August 1, 2020

First Posted

August 7, 2020

Study Start

August 1, 2020

Primary Completion

August 31, 2022

Study Completion

August 31, 2022

Last Updated

August 11, 2020

Record last verified: 2020-08

Data Sharing

IPD Sharing
Will not share

Locations

BE(1)