Tolerance of Early Exercise in Intensive Care Unit

Completed

• Conditions: Critical Illness

• Registration Number: NCT02408250
• Lead Sponsor: University Hospital, Clermont-Ferrand

Brief Summary

Practice guidelines recommend early physical therapy in intensive care unit. Feasibility, safety and efficacy are confirmed by growing evidence based data. However, the scientific literature emphasizes the heterogeneity of targeted populations, lack of precisions concerning eligibility criteria, program modalities, timing initiation, progressions and stopping criteria. However, all these results remain to be precised and confirmed. So, the investigators hypothesize that an early exercise program in intensive care unit formalized from a decisional algorithm is well tolerated in clinical practice.

Detailed Description

Practice guidelines recommend early physical therapy in intensive care unit. Feasibility, safety and efficacy are confirmed by growing evidence based data. However, the scientific literature emphasizes the heterogeneity of targeted populations, lack of precisions concerning eligibility criteria, program modalities, timing initiation, progressions and stopping criteria. However, all these results remain to be precised and confirmed. So, the investigators hypothesize that an early exercise program in intensive care unit formalized from a decisional algorithm is well tolerated in clinical practice.

Study Timeline

• Study First Submitted: 2015-03-16
• Study Start: 2015-04
• Study First Submitted QC: 2015-04-02
• Study First Posted: 2015-04-03
• Primary Completion: 2018-10-31
• Study Completion: 2018-10-31
• Status Verified: 2019-02
• Last Update Submitted: 2019-02-19
• Last Update Posted: 2019-02-20

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 30

Inclusion Criteria

• Men and women
• Over 18 years old
• Hospitalized in intensive care unit
• Patients whose clinical condition allows initiating an early exercise program from critical care physician inclusion

Exclusion Criteria

• Less than 18 years old or disabled adult
• Head or spinal severe trauma
• Severe trauma of the lower limbs or pelvis
• Musculoskeletal and neurological conditions which do not permit to realise the exercise program
• Patient for whom the reason for hospitalization does not justify early physical therapy

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Score difference on a discomfort visual analogic scale between before and after program completion	at day 1

Secondary Outcome Measures

Name	Time	Method
Functional capacity (PFIT: Physical Function ICU Test score)	at day 1
mortality in ICU	at day 1
length of stay on intensive care unit	at day 1
Unit of discharge (specialty of the unit)	at day 1

Trial Locations

Locations (1)

CHU de Clermont-Ferrand; 🇫🇷 Clermont-Ferrand, France