Tolerance of Early Exercise in Intensive Care Unit

Critical Illness Clinical Trial

Official title:

Tolerance of Early Exercise in Intensive Care Unit

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02408250
• Other study ID #: CHU-0226
• Status: Completed
• Start date: April 2015
• Est. completion date: October 31, 2018

Study information

• Verified date: February 2019
• Source: University Hospital, Clermont-Ferrand
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: October 31, 2018
• Est. primary completion date: October 31, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Critical Illness

Intervention

Procedure:
• Exercise program
Exercise program in intensive care unit established from a decisional algorithm and applied to the critical care unit patients

Locations

Country	Name	City	State
France	CHU de Clermont-Ferrand	Clermont-Ferrand

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Clermont-Ferrand

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Score difference on a discomfort visual analogic scale between before and after program completion		at day 1
Secondary	Functional capacity (PFIT: Physical Function ICU Test score)		at day 1
Secondary	length of stay on intensive care unit		at day 1
Secondary	mortality in ICU		at day 1
Secondary	Unit of discharge (specialty of the unit)		at day 1