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

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

Interventions

OTHER

Early Mobilization and endurance training

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.

OTHER

Usual Care

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

Sponsors & Collaborators

• Taichung Tzu Chi Hospital

  lead OTHER

Principal Investigators

• Chi-Wen Lin · Taichung Tzu Chi Hospital, Buddhist Tzu Chi Medical Foundation

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Model

PARALLEL

Eligibility

Min Age

18 Years

Max Age

75 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2022-01-01

Primary Completion

2022-12-31

Completion

2022-12-31

Countries

• Taiwan

Study Locations