Early Exercise Training in Critically Ill Patients

NCT00695383 | Completed

• 1 other identifier: G 0523.06
• Study Type: interventional
• Target: 90
• Locations: 1 country
• Sites: 1

Brief Summary

This randomized controlled trial was designed to investigate whether a daily training session using a bedside cycle ergometer, 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

Critical Illness; Intensive Care; Muscle Weakness; Deconditioning

Keywords

Exercise therapy; Physiotherapy; Critical illness; Intensive care; Muscle weakness; Mechanical ventilation

Outcome Measures

Primary Outcomes (1)

• six-minute walking distance

  hospital discharge

Secondary Outcomes (2)

• quadriceps force

  ICU discharge and hospital discharge

• functional status (Berg Balance Scale, Functional Ambulation Categories, SF-36 Physical Function-item)

  ICU discharge and hospital discharge

Study Arms (2)

1

EXPERIMENTAL

Behavioral: Bedside cycle exercise therapy

2

ACTIVE COMPARATOR

Behavioral: Standard physiotherapy program

Interventions

Bedside cycle exercise therapy BEHAVIORAL

A 20-minute cycling exercise session is performed 5 days a week using a bedside cycle ergometer. Patients can cycle passively and actively against increasing resistance. Besides this, patients receive the standard physiotherapy program as in arm 2

Also known as: exercise therapy, exercise training, exercise, cycle training, cycle exercise, Motomed Letto

1

Standard physiotherapy program BEHAVIORAL

The standard physiotherapy program consists of daily chest physiotherapy and a mobilization session on 5 days per week.

Also known as: Usual physiotherapy, Routine physiotherapy, Mobilization

2

Eligibility Criteria

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

You may qualify if:

• ICU stay \> 5 days
• Expected prolonged stay of at least 7 more days
• Cardiorespiratory status that allows at least passive exercise therapy

You may not qualify if:

• Persistent or progressive neurological or (neuro)muscular disease
• Coagulation disorders (INR \> 1.5, \[BP\] \< 50000/mm³)
• Intracranial pressure \> 20 mmHg
• Psychiatric disorders or severe confusion

Sponsors & Collaborators

• KU Leuven: lead
• Fund for Scientific Research, Flanders, Belgium: collaborator

Study Sites (1)

Department of Rehabilitation Sciences, University Hospitals KULeuven

Leuven, Vlaams-Brabant, 3000, Belgium

Location

MeSH Terms

Conditions

Critical Illness; Muscle Weakness

Interventions

Exercise Therapy; Exercise; Plyometric Exercise

Condition Hierarchy (Ancestors)

Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Muscular Diseases; Musculoskeletal Diseases; Neuromuscular Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms

Intervention Hierarchy (Ancestors)

Rehabilitation; Aftercare; Continuity of Patient Care; Patient Care; Therapeutics; Physical Therapy Modalities; Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena; Physical Conditioning, Human

Study Officials

• Rik Gosselink, PT, phD

  Department of Rehabilitation Sciences, University Hospitals KULeuven

  STUDY DIRECTOR

• Chris Burtin, PT, MSc

  Department of Rehabilitation Sciences, University Hospitals KULeuven

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: June 9, 2008
• First Posted: June 11, 2008
• Study Start: December 1, 2005
• Primary Completion: February 1, 2007
• Study Completion: February 1, 2007
• Last Updated: June 11, 2008

Record last verified: 2008-06

Locations

BE (1)