Tolerance of Early Exercise in Intensive Care Unit

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 Overview

• Status: Completed
• Conditions: Critical Illness
• Intervention / Treatment: Procedure: Exercise program

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 Type: Observational
• Enrollment (Actual): 30

Contacts and Locations

Study Locations

• France
  • Clermont-Ferrand, France, 63003
    • CHU de Clermont-Ferrand

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

critical care unit patients

Description

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 Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Score difference on a discomfort visual analogic scale between before and after program completion	at day 1

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: University Hospital, Clermont-Ferrand

Study record dates

Study Major Dates

• Study Start (Actual): April 1, 2015
• Primary Completion (Actual): October 31, 2018
• Study Completion (Actual): October 31, 2018

Study Registration Dates

• First Submitted: March 16, 2015
• First Submitted That Met QC Criteria: April 2, 2015
• First Posted (Estimate): April 3, 2015

Study Record Updates

• Last Update Posted (Actual): February 20, 2019
• Last Update Submitted That Met QC Criteria: February 19, 2019
• Last Verified: February 1, 2019

More Information

Terms related to this study

• Keywords: intensive care unit; feasibility; algorithm; physical therapy; critical illness; early exercise
• Additional Relevant MeSH Terms: Pathologic Processes; Disease Attributes; Critical Illness
• Other Study ID Numbers: CHU-0226