Study of Safety and Efficacy on Neuromyopathy of Early Standing With the Assistance of Tilt Table in Critically Patients

NCT ID: NCT02047617

Last Updated: 2017-02-27

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 145 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-08-31
• Study Completion Date: 2015-10-31

Brief Summary

Critically ill patients frequently develop muscle weakness due to critical illness-related acute neuropathy and/or myopathy. This disorder is associated with difficulties in weaning from mechanical ventilation, prolonged intensive care unit and hospital stay, and increased mortality rates. In addition, many patients continue to suffer from decreased exercise capacity and quality of life for months to years after the acute event.

Besides controlling risk factors, no specific prevention or treatment exists. Recommendations advice to start early with active and passive exercise in critically ill patients (1). Having critically ill patients alert and engaged in progressive rehabilitation leading to mobilization, despite the use of life support therapies may reduce muscle atrophy and lead to improved strength and physical function (2).

This randomized controlled trial was designed to investigate whether a daily training session using a tilt table, started early in stable critically ill patients with an expected prolonged ICU stay, could induce a beneficial effect on exercise performance, quadriceps force and functional autonomy at ICU and hospital discharge compared to a standard physiotherapy program.

Conditions

Patients Are Recruited From One Thoracic and Cardiac Surgery ICU

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: NONE

Study Groups

the standard physiotherapy group

Physiotherapy rehabilitation techniques used in the management of this group include passive range of motion, active range of motion/bed exercises, sitting at edge of bed, sitting in armchair, active transfer from the bed to chair. Mobilization and rehabilitation program is progressively introduced after clinical stabilization with a goal of progressing to ambulation and pulmonary rehabilitation.

Group Type: ACTIVE_COMPARATOR

the standard physiotherapy group

Intervention Type: DEVICE

Mobilization and rehabilitation program is progressively introduced after clinical stabilization

standing table group

The same program as standard physiotherapy group is applied, with daily sessions of standing table in supplement. Standing table was performed on a motorized tilt table (ref: table de verticalisation, Franco\&fils). The protocol involved a stepwise process to gradually raise the subject into a standing position on the standing table platform, at 10° intervals from 30° to 80°.

Group Type: EXPERIMENTAL

standing table group

Intervention Type: DEVICE

The protocol involved a stepwise process to gradually raise the subject into a standing position on the standing table platform

Interventions

the standard physiotherapy group

Mobilization and rehabilitation program is progressively introduced after clinical stabilization

Intervention Type: DEVICE

standing table group

The protocol involved a stepwise process to gradually raise the subject into a standing position on the standing table platform

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

• Patients who had been intubated and mechanically ventilated for more than 3 days, without weaning of ventilation sheduled in 24 hours

Exclusion Criteria

• Polytrauma,
• Cerebral , spinal cord or spinal injury,
• Pelvic or lower limb fracture

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Centre Chirurgical Marie Lannelongue

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Céline SARFATI, physiotherapist

Role: PRINCIPAL_INVESTIGATOR

Centre Chirurgical Marie Lannelongue

Locations

Centre Chirurgical MarieLannelongue

Le Plessis-Robinson, Île-de-France Region, France

Countries

France

References

Gosselink R, Bott J, Johnson M, Dean E, Nava S, Norrenberg M, Schonhofer B, Stiller K, van de Leur H, Vincent JL. Physiotherapy for adult patients with critical illness: recommendations of the European Respiratory Society and European Society of Intensive Care Medicine Task Force on Physiotherapy for Critically Ill Patients. Intensive Care Med. 2008 Jul;34(7):1188-99. doi: 10.1007/s00134-008-1026-7. Epub 2008 Feb 19.

Reference Type: BACKGROUND

PMID: 18283429 (View on PubMed)

Schweickert WD, Pohlman MC, Pohlman AS, Nigos C, Pawlik AJ, Esbrook CL, Spears L, Miller M, Franczyk M, Deprizio D, Schmidt GA, Bowman A, Barr R, McCallister KE, Hall JB, Kress JP. Early physical and occupational therapy in mechanically ventilated, critically ill patients: a randomised controlled trial. Lancet. 2009 May 30;373(9678):1874-82. doi: 10.1016/S0140-6736(09)60658-9. Epub 2009 May 14.

Reference Type: BACKGROUND

PMID: 19446324 (View on PubMed)

Sarfati C, Moore A, Pilorge C, Amaru P, Mendialdua P, Rodet E, Stephan F, Rezaiguia-Delclaux S. Efficacy of early passive tilting in minimizing ICU-acquired weakness: A randomized controlled trial. J Crit Care. 2018 Aug;46:37-43. doi: 10.1016/j.jcrc.2018.03.031. Epub 2018 Apr 5.

Reference Type: DERIVED

PMID: 29660670 (View on PubMed)

Other Identifiers

IDRCB 2012-A00665-38

Identifier Type: OTHER

Identifier Source: secondary_id

P12-37815003/2012A00665-38

Identifier Type: -

Identifier Source: org_study_id