NCT02920684

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
20

participants targeted

Target at below P25 for phase_3

Timeline
Completed

Started Dec 2016

Shorter than P25 for phase_3

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 25, 2016

Completed
5 days until next milestone

First Posted

Study publicly available on registry

September 30, 2016

Completed
2 months until next milestone

Study Start

First participant enrolled

December 1, 2016

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2017

Completed
Last Updated

August 2, 2017

Status Verified

August 1, 2017

Enrollment Period

8 months

First QC Date

September 25, 2016

Last Update Submit

August 1, 2017

Conditions

Critically Ill Patients Under Mechanical VentilationSedated Patients

Keywords

Early rehabilitationMechanical ventilationPhysiotherapy

Outcome Measures

Primary Outcomes (1)

  • Cardiac output by cardiac ultrasonography

    Every 3 minutes during 10 minutes exercise

Secondary Outcomes (5)

  • Muscular oxygenation of vastus lateralis muscle by Near Infrared Spectroscopy

    Continuously during ten minutes exercise

  • Pulmonary artery Pressure by cardiac ultrasonography

    Every 3 minutes during 10 minutes exercise

  • Tricuspid annular plane systolic excursion by cardiac ultrasonography

    Every 3 minutes during 10 minutes exercise

  • Expiratory volume

    Continuously during ten minutes exercise

  • Respiratory rate

    Continuously during ten minutes exercise

Study Arms (4)

Passive legs mobilisation

ACTIVE COMPARATOR

A physiotherapist performs passive legs movement

Other: Passive legs mobilisation

Passive cycloergometer

ACTIVE COMPARATOR

A motorized cycloergometer performs passive legs cycling

Other: Passive cycloergometer

Muscular electrical stimulation

ACTIVE COMPARATOR

Quadriceps neuromuscular electrical stimulation

Other: Muscular electrical stimulation

FES cycling

ACTIVE COMPARATOR

A motorised cycloergometer performs a quadriceps neuromuscular electrical stimulation during passive

Other: FES cycling

Interventions

Passive legs mobilisationOTHER

A physiotherapist performs a passive leg movement

Passive legs mobilisation
Passive cycloergometerOTHER

A motorised cycloergometer performs a passive cycling

Passive cycloergometer
Muscular electrical stimulationOTHER

A neuromuscular electrical stimulation device performs a quadriceps located stimulation

Muscular electrical stimulation
FES cyclingOTHER

A motorised cycloergometer performs a passive cycling with quadriceps neuromuscular stimulation

FES cycling

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Mechanical ventilation
  • Sedated
  • Ramsay \< 4

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Le Havre, Jacques Monod Hospital

Montivilliers, 76290, France

Location

Related Publications (2)

  • Medrinal C, Combret Y, Prieur G, Robledo Quesada A, Bonnevie T, Gravier FE, Dupuis Lozeron E, Frenoy E, Contal O, Lamia B. Comparison of exercise intensity during four early rehabilitation techniques in sedated and ventilated patients in ICU: a randomised cross-over trial. Crit Care. 2018 Apr 27;22(1):110. doi: 10.1186/s13054-018-2030-0.

    PMID: 29703223DERIVED

  • Medrinal C, Combret Y, Prieur G, Robledo Quesada A, Bonnevie T, Gravier FE, Frenoy E, Contal O, Lamia B. Effects of different early rehabilitation techniques on haemodynamic and metabolic parameters in sedated patients: protocol for a randomised, single-bind, cross-over trial. BMJ Open Respir Res. 2017 Jan 30;4(1):e000173. doi: 10.1136/bmjresp-2016-000173. eCollection 2017.

    PMID: 28255448DERIVED

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD, PhD

Study Record Dates

First Submitted

September 25, 2016

First Posted

September 30, 2016

Study Start

December 1, 2016

Primary Completion

August 1, 2017

Study Completion

August 1, 2017

Last Updated

August 2, 2017

Record last verified: 2017-08

Locations

FR(1)