Effects of Continuous Mobility Training in Prolonged Mechanical Ventilation

NCT05688267 | Completed

• 1 other identifier: 2022CLin
• Study Type: interventional
• Target: 56
• Locations: 1 country
• Sites: 1

Brief Summary

Background: The exercise intervention can help participants with prolonged mechanical ventilation improve ventilator weaning; however, the content of exercise intervention is diverse and inconsistent. Objective: This study aims to design the continuous mobility training and examine the clinical effects in participants with prolonged mechanical ventilation. Methods: This prospective, single-center, concealed allocation, evaluator-blind, randomized control study divided participants transferred from the intensive care unit to the respiratory care center into two groups. The control group underwent the routine ventilator weaning plan and hand bicycle training, while the experimental group underwent routine ventilator weaning plan and continuous mobility training plan. The success rate of ventilator weaning, length of mechanical ventilation, length of stay at the respiratory care center, and total length of hospital stay were analyzed.

Conditions

Prolonged Mechanical Ventilation

Keywords

Mechanical Ventilator; Ventilator Weaning; Exercise

Outcome Measures

Primary Outcomes (1)

• The success rate of ventilator weaning

  The success rate of ventilator weaning

  up to 6 weeks

Secondary Outcomes (3)

• The length of mechanical ventilation

  up to 6 weeks

• The length of stay at the respiratory care center

  up to 6 weeks

• The total length of hospital stay

  up to 12 weeks

Study Arms (2)

Experimental group

EXPERIMENTAL

The continuous mobility training adopted grading exercise level, which was evaluated and implemented by physical therapists, and focused on continuous mobility training courses with different levels. At each stage, the participants were instructed to perform spontaneous breathing exercise, which were confirmed by the physical therapists. The five stages are half-lying on the bed, sitting at the bedside, sitting on the chair, standing and marching on spot.

Other: Continuous Mobility Training

Control group

PLACEBO COMPARATOR

Participants of control group formed the routine care group, received the routine mechanical ventilation weaning plan and underwent hand bicycle training. The physicians assessed the participants and appropriately adjusted the settings of the mechanical ventilation modules to gradually reduce the participants' dependence on mechanical ventilation. Hand bicycle training was conducted by nurse practitioners once a day. The participants' bedhead was raised, and the participants held the cycle ergometer with both hands once they could tolerate upright positions for 15-20 minutes. Training intensity was targeted at the level of symptom limitation, on the basis of a modified Borg scale rating of 3-5. Intermittent and short-term periods of rest were allowed for participants to achieve the goal of a total of 15-20 minutes exercise session.

Other: Usual Care

Interventions

Continuous Mobility Training OTHER

The continuous mobility training adopted 5 grading exercise level, which was evaluated and implemented by physical therapists, and focused on continuous mobility training courses with different levels. At each stage, the participants were instructed to perform spontaneous breathing exercise, which were confirmed by the physical therapists.

Experimental group

Usual Care OTHER

Participants of control group formed the routine care group, received the routine mechanical ventilation weaning plan and underwent hand bicycle training.

Control group

Eligibility Criteria

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

You may qualify if:

• Aged over 18 years, regardless of sex.
• Use of mechanical ventilation and transfer from the intensive care unit to the respiratory care center for weaning.
• Stable vital signs.
• Ability to understand simple instructions and agree to participate in this research program after explanation.

You may not qualify if:

• Unconsciousness, severe cognitive impairment, or inability to follow instructions.
• Severe heart failure (NYHA ≥ 3).
• Diagnosis of terminal illness and undergoing palliative care.
• Inability to receive exercise therapy due to physical conditions, fracture, lower limb surgery, acute thrombosis, open wounds, extracorporeal membrane oxygenation.
• Assessment by other attending physician that the participant's condition, progression of disease course or treatment plan were not suitable for exercise therapy.

Sponsors & Collaborators

• Taichung Tzu Chi Hospital: lead

Study Sites (1)

Taichung Tzu Chi Hospital

Taichang, 427, Taiwan

Location

Related Publications (35)

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MeSH Terms

Conditions

Motor Activity

Condition Hierarchy (Ancestors)

Behavior

Study Officials

• Chi-Wen Lin

  Taichung Tzu Chi Hospital

  STUDY CHAIR

Study Design

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

Study Record Dates

• First Submitted: December 29, 2022
• First Posted: January 18, 2023
• Study Start: February 1, 2023
• Primary Completion: June 17, 2023
• Study Completion: June 20, 2023
• Last Updated: June 22, 2023

Record last verified: 2023-06

Data Sharing

• IPD Sharing: Will not share

Locations

TW (1)