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Early Rehabilitation in Critical Illness Survivors (ER)

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ClinicalTrials.gov Identifier: NCT02754505
Recruitment Status : Completed
First Posted : April 28, 2016
Last Update Posted : April 28, 2016
Sponsor:
Information provided by (Responsible Party):
Tatjana Paternostro-Sluga, Danube Hospital

Brief Summary:

Background: Few studies showed that early rehabilitation on the Intensive Care Unit (ICU) results in a better functional outcome at hospital discharge and reduced hospital stay. Effects of early rehabilitation at the general ward directly after transfer from the ICU on the length of stay (LOS) in hospital and on the functional outcome are missing.

Methods: In a prospective randomised controlled trial (RCT) 53 consecutive critical-illness-survivors were enrolled at nine ICUs. Early rehabilitation program (protocol) consisted of exercise therapy, active breathing techniques and electrical stimulation after discharge from the ICU to ward-based care. The usual care group received physical therapy as ordered by the primary care team after discharge from the ICU. LOS at the general ward after transfer from the ICU was recorded. Furthermore, Early-Rehabilitation-Barthel-Index (ERBI), Visual-Analogue-Scale for pain (VAS), 3-Minute-walk-test (3min), Beck-Depression-Inventory (BDI), State-Trait-Anxiety-Inventory (STAI), and Medical-Research-Council-scale (MRCS) were assessed.


Condition or disease Intervention/treatment Phase
Rehabilitation Other: Early rehabilitation Other: Usual care Not Applicable

  Show Detailed Description

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 53 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Can Early Rehabilitation on the General Ward Following an Intensive Care Unit Stay Reduce Hospital Length of Stay in Critical-illness-survivors? A Randomised Controlled Trial
Study Start Date : February 2008
Actual Primary Completion Date : September 2011
Actual Study Completion Date : December 2011

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Early rehabilitation group
Directly after transfer to a general ward the early rehabilitation group started with an early rehabilitation program, as ordered by an experienced physiatrist. The applied intervention (early rehabilitation) is a combination out of different therapeutic modalities (for further information please see interventions).
Other: Early rehabilitation
The early rehabilitation program consisted of a coordinated exercise therapy and neuromuscular electrical stimulation, for two hours and five days a week until discharge from the acute hospital. Exercise therapy included strength training (three days/week, one to three sets of 12-15 repetitions, 8-10 exercises involving the major muscle groups: thighs, calves, buttocks, trunk, shoulder girdle), aerobic exercise (large muscle activities five days/week, 10-30 min/session, 50-80% maximal heart rate) and active breathing techniques. For neuromuscular electrical stimulation we applied Compex-P© devices producing biphasic symmetric impulses with a frequency of 50 Hz and a pulse width of 0.35 ms (stimulus regime: 8 s on/24 s off) five days/week, 30 min/session involving the anterior thighs and buttocks.

Usual care group
The usual care group received single physical therapy sessions as ordered by the primary care team after transfer from the ICU to the general ward. The applied intervention (usual care) is a combination out of different therapeutic modalities (for further information please see interventions).
Other: Usual care
exercise therapy, respiratory therapy, neuromuscular electrical stimulation (as described above).




Primary Outcome Measures :
  1. days in hospital after transfer from the ICU to a general ward [ Time Frame: up to 52 days ]
    The primary endpoint was defined as days after transfer from the ICU to a general ward until hospital discharge. This was recorded until two months after transfer.



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Ages Eligible for Study:   17 Years and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • > 16 years
  • ICU stay for at least five days
  • APACHE II Score ≥ 20
  • ERBI ≥ -150
  • ability of sitting on the edge of the bed for at least one minute

Exclusion Criteria:

  • disease of the central motor nervous system (e.g. stroke)
  • multiple trauma
  • diagnosis of irreversible condition with little rehabilitation potential (e.g. cardiac insufficiency - New York Heart Association IV)
  • language barrier
  • if a transfer in another hospital was foreseeable

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02754505


Locations
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Austria
Department of Physical Medicine and Rehabilitation, Danube Hospital
Vienna, Austria, 1090
Sponsors and Collaborators
Danube Hospital

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Responsible Party: Tatjana Paternostro-Sluga, Professor, Senior Physician, Danube Hospital
ClinicalTrials.gov Identifier: NCT02754505     History of Changes
Other Study ID Numbers: 375/2007
First Posted: April 28, 2016    Key Record Dates
Last Update Posted: April 28, 2016
Last Verified: April 2016

Keywords provided by Tatjana Paternostro-Sluga, Danube Hospital:
Keywords: intensive care, muscle wasting, discharge, neuromuscular weakness, mobilization

Additional relevant MeSH terms:
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Critical Illness
Disease Attributes
Pathologic Processes