Haemodynamic and Metabolism Response During Early Rehabilitation in Sedated Patients

August 1, 2017 updated by: BOUCHRA LAMIA, University Hospital, Rouen

Despite several positive studies, benefits of early rehabilitation on recovery and motor performance improvement need to be demonstrate. A recent study finds that despite early rehabilitation, 1 survivor of 2 (52%) acquired an ICU weakness. The low intensity exercises applied in intensive care is common and most patients stay in bed.

Under these conditions, the optimal choice of the rehabilitation technique for bedridden patient and its intensity should be studied.

The objective of the study is to evaluate the cardiovascular and metabolic response of patients during four interventions: Passive legs mobilization, Passive cycloergometter, Quadriceps neuromuscular electrical stimulation and Functional electrical stimulation.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

20

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Montivilliers, France, 76290
        • Le Havre, Jacques Monod Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Mechanical ventilation
  • Sedated
  • Ramsay < 4

Exclusion Criteria:

  • Rehabilitation contraindication
  • Patient with pacemaker
  • Patient under volume assist control
  • FiO2 > 80%
  • Patient under neuromuscular blockers
  • Neurologic comorbidity

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Passive legs mobilisation
A physiotherapist performs passive legs movement
Other: Passive legs mobilisation
A physiotherapist performs a passive leg movement
Active Comparator: Passive cycloergometer
A motorized cycloergometer performs passive legs cycling
Other: Passive cycloergometer
A motorised cycloergometer performs a passive cycling
Active Comparator: Muscular electrical stimulation
Quadriceps neuromuscular electrical stimulation
Other: Muscular electrical stimulation
A neuromuscular electrical stimulation device performs a quadriceps located stimulation
Active Comparator: FES cycling
A motorised cycloergometer performs a quadriceps neuromuscular electrical stimulation during passive
Other: FES cycling
A motorised cycloergometer performs a passive cycling with quadriceps neuromuscular stimulation

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Cardiac output by cardiac ultrasonography
Time Frame: Every 3 minutes during 10 minutes exercise
Every 3 minutes during 10 minutes exercise

Secondary Outcome Measures

Outcome Measure
Time Frame
Muscular oxygenation of vastus lateralis muscle by Near Infrared Spectroscopy
Time Frame: Continuously during ten minutes exercise
Continuously during ten minutes exercise
Pulmonary artery Pressure by cardiac ultrasonography
Time Frame: Every 3 minutes during 10 minutes exercise
Every 3 minutes during 10 minutes exercise
Tricuspid annular plane systolic excursion by cardiac ultrasonography
Time Frame: Every 3 minutes during 10 minutes exercise
Every 3 minutes during 10 minutes exercise
Expiratory volume
Time Frame: Continuously during ten minutes exercise
Continuously during ten minutes exercise
Respiratory rate
Time Frame: Continuously during ten minutes exercise
Continuously during ten minutes exercise

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospital, Rouen

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

December 1, 2016

Primary Completion (Actual)

August 1, 2017

Study Completion (Actual)

August 1, 2017

Study Registration Dates

First Submitted

September 25, 2016

First Submitted That Met QC Criteria

September 29, 2016

First Posted (Estimate)

September 30, 2016

Study Record Updates

Last Update Posted (Actual)

August 2, 2017

Last Update Submitted That Met QC Criteria

August 1, 2017

Last Verified

August 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2015-A01633-46

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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