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Haemodynamic and Metabolism Response During Early Rehabilitation in Sedated Patients

U

University Hospital, Rouen

Status and phase

Completed
Phase 3

Conditions

Sedated Patients
Critically Ill Patients Under Mechanical Ventilation

Treatments

Other: Passive legs mobilisation
Other: Passive cycloergometer
Other: Muscular electrical stimulation
Other: FES cycling

Study type

Interventional

Funder types

Other

Identifiers

NCT02920684
2015-A01633-46

Details and patient eligibility

About

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.

Enrollment

20 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Crossover Assignment

Masking

Single Blind

20 participants in 4 patient groups

Passive legs mobilisation
Active Comparator group
Description:
A physiotherapist performs passive legs movement
Treatment:
Other: Passive legs mobilisation
Passive cycloergometer
Active Comparator group
Description:
A motorized cycloergometer performs passive legs cycling
Treatment:
Other: Passive cycloergometer
Muscular electrical stimulation
Active Comparator group
Description:
Quadriceps neuromuscular electrical stimulation
Treatment:
Other: Muscular electrical stimulation
FES cycling
Active Comparator group
Description:
A motorised cycloergometer performs a quadriceps neuromuscular electrical stimulation during passive
Treatment:
Other: FES cycling

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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