Tolerance of Early Exercise in Intensive Care Unit

NCT02408250 | Completed

• 1 other identifier: CHU-0226
• Study Type: observational
• Target: 30
• Locations: 1 country
• Sites: 1

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.

Conditions

Critical Illness

Keywords

algorithm; critical illness; early exercise; feasibility; intensive care unit; physical therapy

Outcome Measures

Primary Outcomes (1)

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

  at day 1

Secondary Outcomes (4)

• 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

Interventions

Exercise program PROCEDURE

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

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

critical care unit patients

You may qualify if:

• Men and women
• Over 18 years old
• Hospitalized in intensive care unit

You may not qualify if:

• 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

Sponsors & Collaborators

• University Hospital, Clermont-Ferrand: lead

Study Sites (1)

CHU de Clermont-Ferrand

Clermont-Ferrand, 63003, France

Location

MeSH Terms

Conditions

Critical Illness; Motor Activity

Interventions

Resistance Training

Condition Hierarchy (Ancestors)

Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Behavior

Intervention Hierarchy (Ancestors)

Exercise Therapy; Rehabilitation; Aftercare; Continuity of Patient Care; Patient Care; Therapeutics; Physical Therapy Modalities; Physical Conditioning, Human; Exercise; Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 16, 2015
• First Posted: April 3, 2015
• Study Start: April 1, 2015
• Primary Completion: October 31, 2018
• Study Completion: October 31, 2018
• Last Updated: February 20, 2019

Record last verified: 2019-02

Locations

FR (1)