Early Rehabilitation in Critical Illness Survivors

NCT02754505 | Completed

• 1 other identifier: 375/2007
• Study Type: interventional
• Target: 53
• Locations: 1 country
• Sites: 1

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.

Conditions

Rehabilitation

Keywords

Keywords: intensive care, muscle wasting, discharge, neuromuscular weakness, mobilization

Outcome Measures

Primary Outcomes (1)

• days in hospital after transfer from the ICU to a general ward

  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.

  up to 52 days

Study Arms (2)

Early rehabilitation group

OTHER

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

Usual care group

OTHER

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

Interventions

Early rehabilitation OTHER

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.

Early rehabilitation group

Usual care OTHER

exercise therapy, respiratory therapy, neuromuscular electrical stimulation (as described above).

Usual care group

Eligibility Criteria

• Age: 17 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• \> 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Danube Hospital: lead

Study Sites (1)

Department of Physical Medicine and Rehabilitation, Danube Hospital

Vienna, Vienna, 1090, Austria

Location

MeSH Terms

Conditions

Muscular Atrophy

Condition Hierarchy (Ancestors)

Neuromuscular Manifestations; Neurologic Manifestations; Nervous System Diseases; Atrophy; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms; Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor, Senior Physician

Study Record Dates

• First Submitted: March 29, 2016
• First Posted: April 28, 2016
• Study Start: February 1, 2008
• Primary Completion: September 1, 2011
• Study Completion: December 1, 2011
• Last Updated: April 28, 2016

Record last verified: 2016-04

Locations

AU (1)