The Effects of Early Mobilization and Endurance Training for Patients With Prolonged Mechanical Ventilator

NCT05154786 | Completed

• 1 other identifier: REC108-28
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

The primary hypothesis is that prolonged mechanically ventilated adults who participate in an early mobilization and endurance exercise training protocol, have an improved pulmonary outcome and functional capacity and more functionally independent at hospital discharge compared to patients receiving the usual physiotherapy care. Further, the investigators expect improvements in weaning rate from mechanical ventilator, less time on mechanical ventilation, a shorter length of stay in the respiratory care center and the hospital, and a higher quality of life at 6 months after hospital discharge compared to patients receiving usual care. The investigators will conduct a prospective, single-center, allocation concealed and assessor-blinded randomised controlled trial with superiority design and 6-month follow-up. The study is being conducted in the interdisciplinary respiratory care center of Taichung Tzu Chi Hospital, Taiwan. To be eligible to participate in the study patients must be aged 18 to 75, be expected to stay on mechanical ventilator for at least 21 days, which reflects a prolonged stay at mechanical ventilator. Standard care (control group) Participants randomised to the control group will receive usual physiotherapy and respiratory care center standard care, which includes weaning protocols and bed exercise program based on previous publications. In this procedure, physiotherapy and mobilization will start after medical prescription. Treatments are based on the therapist's assessment and are accordingly individually tailored. Sessions will usually take place once daily from Monday to Friday. The participants randomised to the experimental group will receive a standardised exercise program involving early mobilization and endurance training. The endurance training will be conducted with grading exercise level. In the course of endurance training, The participants will be prompted verbally for at least 10 min. The aim during all mobilizations will be to involve the participants as actively as possible to promote independence.

Conditions

Mechanical Ventilation Complication

Keywords

Mechanical Ventilators; Weaning; Exercise therapy

Outcome Measures

Primary Outcomes (3)

• Weaning Rate

  weaning from mechanical ventilator

  up to 6 weeks

• Days of Mechanical Ventilator

  days for mechanical ventilator using

  up to 6 weeks

• Length of Stay

  length of stay for RCC

  up to 6 weeks

Secondary Outcomes (2)

• Physical Activity

  up to 6 weeks

• Activity of Daily Life

  up to 6 weeks

Study Arms (2)

Early Mobilization and endurance training

EXPERIMENTAL

Early Mobilization and endurance training for prolonged mechanical ventilator

Other: Early Mobilization and endurance training

Usual care

ACTIVE COMPARATOR

Weaning protocols, bed exercise, and early mobilization.

Other: Usual Care

Interventions

Early Mobilization and endurance training OTHER

The early mobilization and endurance training will be conducted with grading exercise level. In the course of endurance training. After achieving patient's active participation in sitting on the bed, the goal will be to train for at least 20 min. If this is accomplished, exercise level and training period increased until a maximum of 7 on modified RPE. If these are well-tolerated and no contraindications as per medical prescription exist, the treatment will be further advanced to mobilizing participants to the bedside. After being able to sit for at least 10 min on the side of the bed, regardless of whether support is needed, participants will be moved into a chair with an individually adapted transfer according to the individual's resources.While sitting, functional tasks and activities of daily living will be performed and gradually increased to standing and walking exercises.

Early Mobilization and endurance training

Usual Care OTHER

The weaning protocols, bed exercise, positioning, respiratory therapy, and early mobilization.

Usual care

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Stay on mechanical ventilation for at least 21 days
• Stable hemodynamic condition
• Can follow simple oral order

You may not qualify if:

• Consciousness disturbance
• Impaired cognition
• Glucose levels \< 70 or \>200 mg/dL
• Preexisting neurological or neuromuscular disease with functional deficits
• Contraindications to exercise (acute thrombosis, preexisting open wounds)

Sponsors & Collaborators

• Taichung Tzu Chi Hospital: lead

Study Sites (1)

Taichung Tzu Chi Hospital, Buddhist Tzu Chi Medical Foundation

Taichung, Not in USA, 427, Taiwan

Location

Related Publications (8)

• Levine S, Nguyen T, Taylor N, Friscia ME, Budak MT, Rothenberg P, Zhu J, Sachdeva R, Sonnad S, Kaiser LR, Rubinstein NA, Powers SK, Shrager JB. Rapid disuse atrophy of diaphragm fibers in mechanically ventilated humans. N Engl J Med. 2008 Mar 27;358(13):1327-35. doi: 10.1056/NEJMoa070447.

  PMID: 18367735 BACKGROUND

• Zanni JM, Korupolu R, Fan E, Pradhan P, Janjua K, Palmer JB, Brower RG, Needham DM. Rehabilitation therapy and outcomes in acute respiratory failure: an observational pilot project. J Crit Care. 2010 Jun;25(2):254-62. doi: 10.1016/j.jcrc.2009.10.010. Epub 2009 Nov 26.

  PMID: 19942399 BACKGROUND

• Jolley SE, Bunnell AE, Hough CL. ICU-Acquired Weakness. Chest. 2016 Nov;150(5):1129-1140. doi: 10.1016/j.chest.2016.03.045. Epub 2016 Apr 7.

  PMID: 27063347 BACKGROUND

• Kayambu G, Boots R, Paratz J. Physical therapy for the critically ill in the ICU: a systematic review and meta-analysis. Crit Care Med. 2013 Jun;41(6):1543-54. doi: 10.1097/CCM.0b013e31827ca637.

  PMID: 23528802 RESULT

• Elkins M, Dentice R. Inspiratory muscle training facilitates weaning from mechanical ventilation among patients in the intensive care unit: a systematic review. J Physiother. 2015 Jul;61(3):125-34. doi: 10.1016/j.jphys.2015.05.016. Epub 2015 Jun 16.

  PMID: 26092389 RESULT

• Morris PE, Berry MJ, Files DC, Thompson JC, Hauser J, Flores L, Dhar S, Chmelo E, Lovato J, Case LD, Bakhru RN, Sarwal A, Parry SM, Campbell P, Mote A, Winkelman C, Hite RD, Nicklas B, Chatterjee A, Young MP. Standardized Rehabilitation and Hospital Length of Stay Among Patients With Acute Respiratory Failure: A Randomized Clinical Trial. JAMA. 2016 Jun 28;315(24):2694-702. doi: 10.1001/jama.2016.7201.

  PMID: 27367766 RESULT

• Moss M, Nordon-Craft A, Malone D, Van Pelt D, Frankel SK, Warner ML, Kriekels W, McNulty M, Fairclough DL, Schenkman M. A Randomized Trial of an Intensive Physical Therapy Program for Patients with Acute Respiratory Failure. Am J Respir Crit Care Med. 2016 May 15;193(10):1101-10. doi: 10.1164/rccm.201505-1039OC.

  PMID: 26651376 RESULT

• Mendez-Tellez PA, Needham DM. Early physical rehabilitation in the ICU and ventilator liberation. Respir Care. 2012 Oct;57(10):1663-9. doi: 10.4187/respcare.01931.

  PMID: 23013903 RESULT

MeSH Terms

Interventions

Early Ambulation; Endurance Training

Intervention Hierarchy (Ancestors)

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

Study Officials

• Chi-Wen Lin

  Taichung Tzu Chi Hospital, Buddhist Tzu Chi Medical Foundation

  PRINCIPAL INVESTIGATOR

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: Physical Therapist

Study Record Dates

• First Submitted: October 29, 2021
• First Posted: December 13, 2021
• Study Start: January 1, 2022
• Primary Completion: December 31, 2022
• Study Completion: December 31, 2022
• Last Updated: May 3, 2023

Record last verified: 2023-05

Data Sharing

• IPD Sharing: Will not share

Locations

TW (1)