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OpenTrials
Completed

NCT Number: NCT02408250

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

CHU de Clermont-Ferrand

Clermont-Ferrand, 63003, France

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Exercise program

Procedure

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

Primary outcomes

  1. Score difference on a discomfort visual analogic scale between before and after program completion

    Time frame: at day 1

Secondary outcomes

  1. Functional capacity (PFIT: Physical Function ICU Test score)

    Time frame: at day 1

  2. length of stay on intensive care unit

    Time frame: at day 1

  3. mortality in ICU

    Time frame: at day 1

  4. Unit of discharge (specialty of the unit)

    Time frame: at day 1

Sponsors and collaborators

Lead sponsor

University Hospital, Clermont-Ferrand

Other

Registry information

Important dates

Study start
2015
Primary completion
2018
Study completion
2018
First posted
Apr 3, 2015
Registry last updated
Feb 20, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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